Source: CV Sciences, Inc.
Company Addresses its Lead Drug Candidate Aimed at a $2B Market Opportunity
Management of CV Sciences, Inc. (OTCQB: CVSI)
(the "Company", "CV Sciences", "our" or "we"), commented today
regarding the U.S. Department of Defense's (DoD's) recent campaign to
provide assistance to military personnel looking to quit the use of
smokeless tobacco.
Earlier this year, the DoD launched a website and support program called the "Great American Spit-Out" at UcanQuit2.org
to assist servicemen and women in quitting the use of harmful smokeless
tobacco products. The "Great American Spit-Out" webpage on the DoD
website offered referrals across the U.S. to local support groups and an
opportunity for visitors to chat instantly with an online tobacco
cessation coach to provide free counseling to help people deal with
their addiction.
"We greatly appreciate the U.S. Department of
Defense bringing not only awareness but offering solutions available to
the public through the UcanQuit2.org website," explained Michael Mona,
Jr., President and CEO of CV Sciences. "The DoD recognizes the same
problem that we identified during the development of our smokeless
tobacco cessation product. The DoD clearly indicates that by quitting
smokeless tobacco, you can 'drop the risk for developing cancer of the
cheek, gums, and inner surface of the lips.' We strongly believe that
highlighting these examples is critical as we at CV Sciences are
addressing a massive unmet medical need in the treatment of smokeless
tobacco addiction. Currently, there are no FDA-approved drugs to treat
this widespread and deadly addiction. Our lead drug candidate, CVSI-007,
is aimed at addressing this huge unmet need. We estimate that the
current treatment market in the U.S. alone is greater than $2 billion."
The DoD's site lists the dangers of smokeless tobacco and provides support resources here:
https://ucanquit2.org/Events/2017/Great-American-Spit-Out-2017.aspx
About CV Sciences, Inc.
CV Sciences, Inc. (OTCQB: CVSI)
operates two distinct business segments: a drug development division
focused on developing and commercializing novel therapeutics utilizing
synthetic CBD; and, a consumer product division in manufacturing,
marketing and selling plant-based CBD products to a range of market
sectors. CV Sciences, Inc. has primary offices and facilities in San
Diego, California and Las Vegas, Nevada. Additional information is
available from OTCMarkets.com or by visiting www.cvsciences.com.
We focus on assisting private and public companies by creating industry specific investor relations programs that raise awareness.
Monday, March 27, 2017
CV Sciences, Inc. Launches First Online Education Platform for Retail Sales Associates and Industry Professionals
Source: CV Sciences, Inc. Source: Experticity
Company expands hemp-derived CBD education efforts and builds expertise and brand advocacy amongst its growing number of wholesale and retailer partners
CV Sciences, Inc., (OTCBB: CVSI) preeminent supplier and manufacturer of hemp-derived CBD oil bulk and consumer products, today announced the launch of the first online education platform designed to enhance its brand education and advocacy through Experticity. Currently over 750 consumer brands, including The North Face, Dyson, and Quiksilver, are working with Experticity to educate and tap into real-life experts (industry professionals, category opinion leaders, online influencers and passionate retail sales associates) to create a new breed of buying experience -- one that is informed, genuine and mutually beneficial for retailers and consumers. CV Sciences' education platform will cover a variety of topics pertaining to hemp, phytocannabinoids, and its industry-dominating consumer products brand, PlusCBD Oil™.
A recent study by Experticity has shown that education-based trainings have proven effective at increasing sales, with Experticity members having 22.2 times more buying conversations each week that involve product recommendations than the average person. Eighty-two percent of those who received Experticity member recommendations also ended up purchasing products as a result.
"Investing in retailer education is a practice we know demonstrates results," states Sarah Syed, Director of Marketing at CV Sciences. "CV Sciences is dedicated to supporting our retailer and wholesale partners by employing methods we know have a broad impact on consumer buying decisions."
The expertise and understanding of the value of business-to-business geared education shines through industry professionals overseeing CV Sciences' marketing and education programs. "The relationship was a natural fit for us," said Ms. Syed. "Experticity's online training platforms are an effective way to ensure that front-line sales associates in retail outlets are completely up to speed on our brand, products, and their features. As PlusCBD Oil™ continues to be sold by hundreds of retail sales associates across the United States, we are proud to be the first hemp-derived CBD manufacturer to offer this unique approach to sales. We believe it enhances our existing efforts to be the educators in the hemp-derived CBD marketplace."
CV Sciences' commitment to education is what sets PlusCBD Oil™ apart from the plethora of hemp-derived CBD brands entering the marketplace. Beyond educating its retailer partners, the company offers ongoing education programs to the public to ensure consumers are learning the most up-to-date information on hemp-derived CBD, the state of the hemp industry, and ultimately what to look for in purchasing the right hemp-derived product.
For more information on CV Sciences' education efforts, please contact education@cvsciences.com.
ABOUT EXPERTICITY: Experticity (www.experticity.com) has built the world's largest community of influential category experts, connecting them with the world's top brands to create a new breed of buying experience -- one that is informed, genuine and mutually beneficial. Experticity's community of more than a million experts is comprised of industry professionals, category opinion leaders, online influencers and passionate retail sales associates who are actively sought out for trusted recommendations on what to buy. To learn more about Experticity and how its rapidly growing community of brands and experts are transforming today's buying experience, visit experticity.com.
ABOUT CV SCIENCES: CV Sciences, Inc. (OTCBB: CVSI), located in Las Vegas, Nevada, focuses on drug development activities on products containing cannabidiol (CBD) as the active pharmaceutical ingredient, and also is engaged in the development, marketing and sale of end consumer products containing CBD, which is refined into its PlusCBD Oil™ brand. Additional information is available from OTCMarkets.com or by visiting PlusCBDoil.com.
Company expands hemp-derived CBD education efforts and builds expertise and brand advocacy amongst its growing number of wholesale and retailer partners
CV Sciences, Inc., (OTCBB: CVSI) preeminent supplier and manufacturer of hemp-derived CBD oil bulk and consumer products, today announced the launch of the first online education platform designed to enhance its brand education and advocacy through Experticity. Currently over 750 consumer brands, including The North Face, Dyson, and Quiksilver, are working with Experticity to educate and tap into real-life experts (industry professionals, category opinion leaders, online influencers and passionate retail sales associates) to create a new breed of buying experience -- one that is informed, genuine and mutually beneficial for retailers and consumers. CV Sciences' education platform will cover a variety of topics pertaining to hemp, phytocannabinoids, and its industry-dominating consumer products brand, PlusCBD Oil™.
A recent study by Experticity has shown that education-based trainings have proven effective at increasing sales, with Experticity members having 22.2 times more buying conversations each week that involve product recommendations than the average person. Eighty-two percent of those who received Experticity member recommendations also ended up purchasing products as a result.
"Investing in retailer education is a practice we know demonstrates results," states Sarah Syed, Director of Marketing at CV Sciences. "CV Sciences is dedicated to supporting our retailer and wholesale partners by employing methods we know have a broad impact on consumer buying decisions."
The expertise and understanding of the value of business-to-business geared education shines through industry professionals overseeing CV Sciences' marketing and education programs. "The relationship was a natural fit for us," said Ms. Syed. "Experticity's online training platforms are an effective way to ensure that front-line sales associates in retail outlets are completely up to speed on our brand, products, and their features. As PlusCBD Oil™ continues to be sold by hundreds of retail sales associates across the United States, we are proud to be the first hemp-derived CBD manufacturer to offer this unique approach to sales. We believe it enhances our existing efforts to be the educators in the hemp-derived CBD marketplace."
CV Sciences' commitment to education is what sets PlusCBD Oil™ apart from the plethora of hemp-derived CBD brands entering the marketplace. Beyond educating its retailer partners, the company offers ongoing education programs to the public to ensure consumers are learning the most up-to-date information on hemp-derived CBD, the state of the hemp industry, and ultimately what to look for in purchasing the right hemp-derived product.
For more information on CV Sciences' education efforts, please contact education@cvsciences.com.
ABOUT EXPERTICITY: Experticity (www.experticity.com) has built the world's largest community of influential category experts, connecting them with the world's top brands to create a new breed of buying experience -- one that is informed, genuine and mutually beneficial. Experticity's community of more than a million experts is comprised of industry professionals, category opinion leaders, online influencers and passionate retail sales associates who are actively sought out for trusted recommendations on what to buy. To learn more about Experticity and how its rapidly growing community of brands and experts are transforming today's buying experience, visit experticity.com.
ABOUT CV SCIENCES: CV Sciences, Inc. (OTCBB: CVSI), located in Las Vegas, Nevada, focuses on drug development activities on products containing cannabidiol (CBD) as the active pharmaceutical ingredient, and also is engaged in the development, marketing and sale of end consumer products containing CBD, which is refined into its PlusCBD Oil™ brand. Additional information is available from OTCMarkets.com or by visiting PlusCBDoil.com.
CV Sciences, Inc. Highlights Major League Baseball (MLB) Decision to Prohibit All New Players From Using Smokeless Tobacco
Source: CV Sciences, Inc.
CV Sciences, Inc. (OTCBB: CVSI) (the "Company", "CV Sciences", "our" or "we"), today provided comments from its management with regards to the MLB's recent ban on smokeless chewing tobacco for new players.
Beginning this upcoming season, cities that include San Francisco, Boston, and Los Angeles will ban smokeless tobacco in the big-league ballparks and other sports venues. The city councils of Chicago and New York recently approved similar prohibitions on smokeless tobacco for Wrigley Field, U.S. Cellular Field, Citi Field and Yankee Stadium.
Michael Mona, Jr., President and CEO of CV Sciences commented, "We applaud baseball's new labor agreement that prohibits all new players from using smokeless tobacco, like chew, dip and snuff. The recent death of former San Diego Padres Hall of Famer Tony Gwynn has highlighted the seriousness of the issue. Mr. Gwynn attributed his long struggle with salivary gland cancer directly to his many years of chewing tobacco. Curt Schilling, former Boston Red Sox pitcher revealed his diagnosis of oral cancer which he stated was 'without a doubt, unquestionably' due to decades of chewing tobacco. We strongly believe that highlighting these examples are critical as we at CV Sciences are addressing a massive unmet medical need in the treatment of smokeless tobacco addiction. Currently, there are no FDA-approved drugs to treat this widespread and deadly addiction. Our lead drug candidate, CVSI-007, is aimed at addressing this huge unmet need. We estimate that the current treatment market in the U.S. alone is greater than $2 billion."
An article on baseballs' decision can be found here: http://tobaccofreebaseball.org/content/press-release-12_1_2016/
About CV Sciences, Inc.
CV Sciences, Inc. (OTCBB: CVSI) operates two distinct business segments: a drug development division focused on developing and commercializing novel therapeutics utilizing synthetic CBD; and, a consumer product division in manufacturing, marketing and selling plant-based CBD products to a range of market sectors. CV Sciences, Inc. has primary offices and facilities in Las Vegas, Nevada and San Diego, California. Additional information is available from OTCMarkets.com or by visiting www.cvsciences.com.
CV Sciences, Inc. (OTCBB: CVSI) (the "Company", "CV Sciences", "our" or "we"), today provided comments from its management with regards to the MLB's recent ban on smokeless chewing tobacco for new players.
Beginning this upcoming season, cities that include San Francisco, Boston, and Los Angeles will ban smokeless tobacco in the big-league ballparks and other sports venues. The city councils of Chicago and New York recently approved similar prohibitions on smokeless tobacco for Wrigley Field, U.S. Cellular Field, Citi Field and Yankee Stadium.
Michael Mona, Jr., President and CEO of CV Sciences commented, "We applaud baseball's new labor agreement that prohibits all new players from using smokeless tobacco, like chew, dip and snuff. The recent death of former San Diego Padres Hall of Famer Tony Gwynn has highlighted the seriousness of the issue. Mr. Gwynn attributed his long struggle with salivary gland cancer directly to his many years of chewing tobacco. Curt Schilling, former Boston Red Sox pitcher revealed his diagnosis of oral cancer which he stated was 'without a doubt, unquestionably' due to decades of chewing tobacco. We strongly believe that highlighting these examples are critical as we at CV Sciences are addressing a massive unmet medical need in the treatment of smokeless tobacco addiction. Currently, there are no FDA-approved drugs to treat this widespread and deadly addiction. Our lead drug candidate, CVSI-007, is aimed at addressing this huge unmet need. We estimate that the current treatment market in the U.S. alone is greater than $2 billion."
An article on baseballs' decision can be found here: http://tobaccofreebaseball.org/content/press-release-12_1_2016/
About CV Sciences, Inc.
CV Sciences, Inc. (OTCBB: CVSI) operates two distinct business segments: a drug development division focused on developing and commercializing novel therapeutics utilizing synthetic CBD; and, a consumer product division in manufacturing, marketing and selling plant-based CBD products to a range of market sectors. CV Sciences, Inc. has primary offices and facilities in Las Vegas, Nevada and San Diego, California. Additional information is available from OTCMarkets.com or by visiting www.cvsciences.com.
Tuesday, March 7, 2017
Cellular Biomedicine Group Awarded $2.29 Million Grant from the California Institute for Regenerative Medicine (CIRM) to Fund AlloJoin™ Allogeneic Stem Cell Therapy for Knee Osteoarthritis (KOA) in the U.S.
Source: Cellular Biomedicine Group, Inc.
Cellular Biomedicine Group Inc. (NASDAQ:CBMG) (“CBMG”
or the “Company”), a clinical-stage biopharmaceutical firm engaged in
the development of effective immunotherapies for cancer and stem cell
therapies for degenerative diseases, announced today that the governing
Board of the California Institute for Regenerative Medicine (CIRM),
California's stem cell agency, has awarded the Company $2.29 million to
support pre-clinical studies of AlloJoinTM, CBMG’s
“Off-the-Shelf” Allogeneic Human Adipose-derived Mesenchymal Stem Cells
for the treatment of Knee Osteoarthritis in the United States.
While
CBMG recently commenced two Phase I human clinical trials in China
using CAR-T to treat relapsed/refractory CD19+ B-cell Acute
Lymphoblastic Leukemia (ALL) and Refractory Diffuse Large B-cell
Lymphoma (DLBCL) as well as an ongoing Phase I trial in China for
AlloJoinTM in Knee Osteoarthritis (KOA), this latest
announcement represents CBMG’s initial entrance into the United States
for its “off-the-shelf” allogeneic stem cell candidate AlloJoinTM.
The
$2.29 million was granted under the CIRM 2.0 program, a comprehensive
collaborative initiative designed to accelerate the development of stem
cell-based treatments for people with unmet medical needs. After the
award, CIRM will be a more active partner with its recipients to further
increase the likelihood of clinical success and help advance a
pre-clinical applicant’s research along a funding pipeline towards
clinical trials. CBMG’s KOA pre-clinical program is considered
late-stage, and therefore it meets CIRM 2.0’s intent to accelerate
support for clinical stage development for identified candidates of stem
cell treatments that demonstrate scientific excellence.
"We
are deeply appreciative to CIRM for their support and validation of the
therapeutic potential of our KOA therapy,” said Tony (Bizuo) Liu, Chief
Executive Officer of CBMG. “We thank Dr. C. Thomas Vangsness, Jr., in
the Department of Orthopaedic Surgery at the Keck School of Medicine of
the University of Southern California and Dr. Qing Liu-Michael at the
Broad Center for Regenerative Medicine and Stem Cell Research at USC,
who helped significantly with the grant application process. The CIRM
grant is the first step in bringing our allogeneic human adipose-derived
mesenchymal stem cell treatment for knee osteoarthritis (AlloJoinTM) to the U.S. market.
Our AlloJoinTM
program has previously undergone extensive manufacturing development
and pre-clinical studies and is undergoing a Phase I clinical trial in
China. In order to demonstrate comparability with cell banks previously
produced in China for our U.S. IND filing, we are addressing the
pre-clinical answers required for the FDA. With the funds provided by
CIRM, we will replicate and validate the manufacturing process and
control system at the cGMP facility located at Children’s Hospital Los
Angeles to support the filing of an IND with the FDA. The outcome of
this grant will enable us to have qualified final cell products ready to
use in a Phase I clinical trial with Dr. Vangsness as the Principal
Investigator and the Keck School of Medicine of USC as a trial site. Dr.
Vangsness is familiar with both stem cell biology and KOA, and has led
the only randomized double-blind human clinical study to investigate
expanded allogeneic mesenchymal stem cells to date. Our endeavor in the
U.S. market will further strengthen our commercialization pipeline.”
CBMG recently announced promising interim 3-month safety data from its Phase I clinical trial in China for AlloJoinTM, its off-the-shelf allogeneic stem cell therapy for KOA. The trial is on schedule to be completed by the third quarter of 2017.
About CIRM
At
CIRM, we never forget that we were created by the people of California
to accelerate stem cell treatments to patients with unmet medical needs,
and to act with a sense of urgency commensurate with that mission. To
meet this challenge, our team of highly trained and experienced
professionals actively partners with both academia and industry in a
hands-on, entrepreneurial environment to fast track the development of
today's most promising stem cell technologies.
With
$3 billion in funding and over 280 active stem cell programs in our
portfolio, CIRM is the world's largest institution dedicated to helping
people by bringing the future of medicine closer to reality.
For more information, please visit www.cirm.ca.gov.
About Knee Osteoarthritis
According
to the Foundation for the National Institutes of Health, there are 27
million Americans with Osteoarthritis (OA), and symptomatic Knee
Osteoarthritis (KOA) occurs in 13% of persons aged 60 and older. The
International Journal of Rheumatic Diseases, 2011 reports that
approximately 57 million people in China suffer from KOA. Currently no
treatment exists that can effectively preserve knee joint cartilage or
slow the progression of KOA. Current common drug-based methods of
management, including anti-inflammatory medications (NSAIDs), only
relieve symptoms and carry the risk of side effects. Patients with KOA
suffer from compromised mobility, leading to sedentary lifestyles;
doubling the risk of cardiovascular diseases, diabetes, and obesity; and
increasing the risk of all causes of mortality, colon cancer, high
blood pressure, osteoporosis, lipid disorders, depression and anxiety.
According to the Epidemiology of Rheumatic Disease (Silman AJ, Hochberg
MC. Oxford Univ. Press, 1993:257), 53% of patients with KOA will eventually become disabled.
About Cellular Biomedicine Group (CBMG)
Cellular
Biomedicine Group, Inc. develops proprietary cell therapies for the
treatment of cancer and degenerative diseases. Our immuno-oncology and
stem cell projects are the result of research and development by CBMG’s
scientists and clinicians from both China and the United States. Our GMP
facilities in China, consisting of twelve independent cell production
lines, are designed and managed according to both China and U.S. GMP
standards. To learn more about CBMG, please visit www.cellbiomedgroup.com.Cellular Biomedicine Group (CBMG) Approved to Commence Phase I Trial (CALL-1) for C-CAR011 in Adult Patients with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (ALL) in China
Source: Cellular Biomedicine Group, Inc.
Cellular Biomedicine Group Inc. (NASDAQ:CBMG)
(“CBMG” or the “Company”), a clinical-stage biomedicine firm engaged in
the development of effective immunotherapies for cancer and stem cell
therapies for degenerative diseases, is pleased to announce the approval
and commencement of patient enrollment in China for its CALL-1 (“CAR-T
against Acute Lymphoblastic Leukemia”) Phase I clinical trial utilizing
its optimized proprietary C-CAR011 construct of CD19 chimeric antigen
receptor T-cell (CAR-T) therapy for the treatment of patients with
relapsed or refractory (r/r) CD19+ B-cell Acute Lymphoblastic Leukemia
(ALL). The CALL-1 trial has begun enrollment with final data expected to
be available at the end of 2017. Depending on the Phase I CALL-1
results, CBMG expects to initiate a larger Phase II clinical trial as
soon as practicable.
“Our CALL-1 trial represents the second CBMG-sponsored clinical trial after the recent launch of our CARD-1 trial in refractory DLBCL patients.
This is another major corporate milestone and demonstrates CBMG’s
ability to execute on our immuno-oncology plan and to forward our
prioritized assets into clinical development in China,” said Tony
(Bizuo) Liu, Chief Executive Officer of CBMG.
CBMG’s
CALL-1 Phase I dose-escalation trial will use the 3+3 design to
evaluate the safety, efficacy and persistence of C-CAR011 in CD19+ r/r
ALL patients.
“Relapsed or refractory CD19+
adult ALL patients have limited options and poor prognosis,” said Dr. Li
Yu from the PLA General Hospital (“PLAGH”), the Principal Investigator
for the CALL-1 trial. “I am excited to be able to participate in the
trial of C-CAR011 which may someday provide a treatment option for these
patients.”
“We are excited to launch this trial
to better understand the potential C-CAR011 can have to address a large
cancer population in China,” said Dr. Yihong Yao, Chief Scientific
Officer of CBMG.
About the CALL-1 Clinical Trial
CALL-1 is a Phase I single-site, single-arm dose-escalating trial consisting of three patient cohorts using escalating C-CAR011 cell dosing levels with three patients in each cohort. Phase I dose expansion will enroll an additional 6-12 patients to confirm the optimal dose. The primary end points are Dose-Limiting Toxicity (DLT) and Treatment Emergent Adverse Events (TEAE). Secondary endpoints will measure Overall Response Rate (CR + CRi, complete remission with incomplete hematopoietic recovery), MRD-CR rate at 8 weeks according to the NCCN Guideline Version 2.2016, Acute Lymphoblastic Leukemia, and overall survival at 6 months.
CALL-1 is a Phase I single-site, single-arm dose-escalating trial consisting of three patient cohorts using escalating C-CAR011 cell dosing levels with three patients in each cohort. Phase I dose expansion will enroll an additional 6-12 patients to confirm the optimal dose. The primary end points are Dose-Limiting Toxicity (DLT) and Treatment Emergent Adverse Events (TEAE). Secondary endpoints will measure Overall Response Rate (CR + CRi, complete remission with incomplete hematopoietic recovery), MRD-CR rate at 8 weeks according to the NCCN Guideline Version 2.2016, Acute Lymphoblastic Leukemia, and overall survival at 6 months.
Dr.
Li Yu, Director emeritus, Professor and Chief Physician of the
Department of Hematology at the PLAGH in Beijing, China will conduct the
trial. The PLAGH was founded in 1953 and is a top-ranking medical
center in China, integrating medical care, education and research. The
PLAGH has 125 clinical, medical and technological departments, 4,000
patient beds with annual volumes of more than 3.8 million outpatient
visits, 110,000 admissions and over 65,000 surgical operations
performed.
About C-CAR011
CBMG’s proprietary anti-CD19 chimeric antigen receptor T-cell (CAR-T) construct represents advancement over CBMG’s prior CBM-C19.1 construct, which completed a human proof-of-concept trial demonstrating an optimistic response rate with controllable toxicities. C-CAR011 is entirely engineered and manufactured in CBMG’s own GMP manufacturing facility in China.
CBMG’s proprietary anti-CD19 chimeric antigen receptor T-cell (CAR-T) construct represents advancement over CBMG’s prior CBM-C19.1 construct, which completed a human proof-of-concept trial demonstrating an optimistic response rate with controllable toxicities. C-CAR011 is entirely engineered and manufactured in CBMG’s own GMP manufacturing facility in China.
About Acute Lymphoblastic Leukemia (ALL)
Acute Lymphoblastic Leukemia (ALL), also called acute lymphocytic leukemia, starts from the early type of white blood cells called lymphocytes in the bone marrow. The leukemia cells then invade the blood fairly quickly and may spread to other parts of the body, including the lymph nodes, liver, spleen, central nervous system (brain and spinal cord), and testicles (in males). The World Health Organization defines "acute" when greater than 20% of the cells in the bone marrow are blasts, which can progress quickly, and if untreated, would likely be fatal within months. According to the U.S. National Cancer Institute, 6,600 patients are diagnosed with ALL in the U.S. annually. Additionally, it is estimated that 27,000 patients in China will be diagnosed with ALL annually. While pediatric patients make up approximately 60% of the total and achieve an 85% effective cure rate, only 40% of Adult ALL patients achieve long-term disease-free survival.
Acute Lymphoblastic Leukemia (ALL), also called acute lymphocytic leukemia, starts from the early type of white blood cells called lymphocytes in the bone marrow. The leukemia cells then invade the blood fairly quickly and may spread to other parts of the body, including the lymph nodes, liver, spleen, central nervous system (brain and spinal cord), and testicles (in males). The World Health Organization defines "acute" when greater than 20% of the cells in the bone marrow are blasts, which can progress quickly, and if untreated, would likely be fatal within months. According to the U.S. National Cancer Institute, 6,600 patients are diagnosed with ALL in the U.S. annually. Additionally, it is estimated that 27,000 patients in China will be diagnosed with ALL annually. While pediatric patients make up approximately 60% of the total and achieve an 85% effective cure rate, only 40% of Adult ALL patients achieve long-term disease-free survival.
About Cellular Biomedicine Group (CBMG)
Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of cancer and degenerative diseases. Our immuno-oncology and stem cell projects are the result of research and development by CBMG’s scientists and clinicians from both China and the United States. Our GMP facilities in China, consisting of twelve independent cell production lines, are designed and managed according to both China and U.S. GMP standards. To learn more about CBMG, please visit: www.cellbiomedgroup.com
Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of cancer and degenerative diseases. Our immuno-oncology and stem cell projects are the result of research and development by CBMG’s scientists and clinicians from both China and the United States. Our GMP facilities in China, consisting of twelve independent cell production lines, are designed and managed according to both China and U.S. GMP standards. To learn more about CBMG, please visit: www.cellbiomedgroup.com
Cellular Biomedicine Group (CBMG) Expands Cell Production With Capacity to Produce CAR-T Therapies to Treat 10,000 Cancer Patients Annually
Source: Cellular Biomedicine Group, Inc.
Cellular Biomedicine Group Inc. (NASDAQ:CBMG)
(“CBMG” or the “Company”), a clinical-stage biomedicine firm engaged in
the development of effective immunotherapies for cancer and stem cell
therapies for degenerative diseases, is pleased to announce the signing
of a ten-year lease of a 113,038 square feet building located in the
“Pharma Valley” in Shanghai Zhangjiang High-Tech Park. The new GMP
facility that will be built on these premises will consist of 40,000
square feet dedicated to advanced cell manufacturing. By the end of
2017, the Company anticipates that the new Zhangjiang, an expanded Wuxi,
and Beijing GMP facilities combined will have 70,000 square feet, and
the Company expects that it will be capable of supporting simultaneous
clinical trials for five different CAR-T and stem cell products, or
approximately the ability to treat 10,000 cancer patients and 10,000
stem cell patients per year.
“We are very
excited to continue to add to our in-house manufacturing capabilities.
This new development, once built out, will substantially expand our
total production facility’s square footage across three key cities in
China. In conjunction with the upcoming expanded GMP facility in Wuxi
for clinical grade Plasmid and Viral Vectors bank production, we will
have an integrated Chemistry, Manufacturing, and Controls (“CMC”)
process for CAR-T production through predominately closed and automated
systems. We believe this will enable us to serve scaled-up demand for
our current and future CAR-T clinical studies and will allow CBMG to
move quickly and efficiently from R&D into manufacturing of CAR-T
cells for clinical use, IND filings, and future commercialization,” said
Tony (Bizuo) Liu, Chief Executive Officer of CBMG.
CBMG
recently announced the approval and commencement of patient enrollment
in China for its CARD-1 Phase I clinical trial utilizing its optimized
proprietary C-CAR011 construct of CD19 chimeric antigen receptor T-cell
(CAR-T) therapy for the treatment of patients with refractory Diffuse
Large B-cell Lymphoma (DLBCL) as well as announcing promising interim
3-month safety data from its Phase I clinical trial in China for
AlloJoin™ off-the-shelf allogeneic stem cell therapy for Knee
Osteoarthritis (KOA).
About Cellular Biomedicine Group (CBMG)
Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of cancer and degenerative diseases. Our immuno-oncology and stem cell projects are the result of research and development by CBMG’s scientists and clinicians from both China and the United States. Our GMP facilities in China, consisting of twelve independent cell production lines, are designed and managed according to both China and U.S. GMP standards. To learn more about CBMG, please visit: www.cellbiomedgroup.com
Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of cancer and degenerative diseases. Our immuno-oncology and stem cell projects are the result of research and development by CBMG’s scientists and clinicians from both China and the United States. Our GMP facilities in China, consisting of twelve independent cell production lines, are designed and managed according to both China and U.S. GMP standards. To learn more about CBMG, please visit: www.cellbiomedgroup.com
Cellular Biomedicine Group Announces Three-Month Interim Safety Data from Phase I Clinical Trial for AlloJoin™ Off-the-Shelf Allogeneic Stem Cell Therapy for Knee Osteoarthritis
Source: Cellular Biomedicine Group, Inc.
AlloJoin™ Phase I 12-week Preliminary Safety Data Summary
The Phase I study of AlloJoin™ for KOA is led by Shanghai Renji Hospital, one of the largest teaching hospitals in China, with Principal Investigator ChunDe Bao, MD, Professor of Medicine, Vice Chairman of the Chinese Rheumatology Association. The Institutional Review Board (IRB)-approved study enrolled 18 patients with knee osteoarthritis (Kellgren-Lawrence Grading Scale: grade II-III) to participate in the randomized, double blinded trial. The patients received two dose intra-articular injections at three-week intervals.
An archived presentation is available on the Company website here:
http://www.cellbiomedgroup.com/investor-relations/presentations/.
- No Serious Adverse Events Observed-
Cellular Biomedicine Group Inc. (NASDAQ:CBMG)
(“CBMG” or the “Company”), a clinical-stage biomedicine firm engaged in
the development of effective immunotherapies for cancer and stem cell
therapies for degenerative diseases, today announced interim 3-month
safety data from its Phase I clinical trial in China for
AlloJoin™ off-the-shelf allogeneic stem cell therapy for Knee
Osteoarthritis (KOA). The preliminary data was presented on December 8th
at the World Stem Cell Summit in West Palm Beach, Florida. The interim
analysis of the trial has preliminarily demonstrated a safety and
tolerability profile of AlloJoin™ in the three doses tested, and adverse
events (AE) are similar to that of the Company’s prior autologous
trials. No serious adverse events (SAE) have been observed. The trial
is on schedule to be completed by the third quarter of 2017.
“We
are very pleased with the results of the trial in China thus far and we
look forward to the full data readout including symptom and disease
modification efficacy measurements at the 6 month and 12 month time
points,” said Dr. Richard Wang, Chief Operating Officer of Cellular
Biomedicine Group, and GM of the Stem Cell Therapy Business Unit. “The
preliminary results of the CBMG proprietary allogeneic stem cell
technology have encouraged us to continue to explore clinical safety and
efficacy of the therapy in patients with Knee Osteoarthritis, to
reproduce the positive cartilage regeneration results observed in our
autologous trials with ReJoin®, and to apply for late phase registration
trials to potentially launch the first disease modification therapy for
KOA. The development of an allogeneic product could increase the number
of patients that can be treated by manufactured haMPCs from a single
healthy donor as an off-the-shelf treatment, allowing for ease of
manufacturing and clinical use at a much lower cost. We continue to
evaluate the feasibility of initiating a clinical study of AlloJoin™ for
KOA under an IND in the United States."
- Because subjects are still blinded, there is no break-down information available for the three dosing groups
- No SAEs have been observed for any patients in the trial (similar to the Company’s autologous trials)
- The most common AEs are knee pain and swelling after injection
- The severity of AE is similar to that of the Company’s autologous trials (mild to moderate)
- The occurrence appears different from the Company’s autologous trials; more patients reported pain (77% vs. 50%) and less reported swelling (54% vs. 72%)
- The Company will report further safety data and efficacy data at the 6-month and 12-month periods
The Phase I study of AlloJoin™ for KOA is led by Shanghai Renji Hospital, one of the largest teaching hospitals in China, with Principal Investigator ChunDe Bao, MD, Professor of Medicine, Vice Chairman of the Chinese Rheumatology Association. The Institutional Review Board (IRB)-approved study enrolled 18 patients with knee osteoarthritis (Kellgren-Lawrence Grading Scale: grade II-III) to participate in the randomized, double blinded trial. The patients received two dose intra-articular injections at three-week intervals.
The
primary endpoint for this trial is safety after cell therapy. The
secondary endpoints are knee-related pain, stiffness and function
measured using the Western Ontario and McMaster Universities (WOMAC)
osteoarthritis index questionnaire and cartilage repair/regeneration
post cell therapy, defined through changes of both knee joints’
cartilage volume measured with 3D spoiled gradient-recalled echo (SPGR)
quantitative magnetic resonance imaging (MRI) and read with a
semi-automated segmentation method (ITK-SNAP). A number of biomarkers
and their changes in response to the therapy will also be studied as
exploratory end points. The trial is registered with the U.S. National
Institutes of Health (NIH) under the number NCT02641860 (click here to view).
http://www.cellbiomedgroup.com/investor-relations/presentations/.
About Cellular Biomedicine Group (CBMG)
Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of cancer and degenerative diseases. Our immuno-oncology and stem cell projects are the result of research and development by CBMG’s scientists and clinicians from both China and the United States. Our GMP facilities in China, consisting of twelve independent cell production lines, are designed and managed according to both China and U.S. GMP standards. To learn more about CBMG, please visit: www.cellbiomedgroup.com
Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of cancer and degenerative diseases. Our immuno-oncology and stem cell projects are the result of research and development by CBMG’s scientists and clinicians from both China and the United States. Our GMP facilities in China, consisting of twelve independent cell production lines, are designed and managed according to both China and U.S. GMP standards. To learn more about CBMG, please visit: www.cellbiomedgroup.com
Cellular Biomedicine Group (CBMG) Approved to Commence Phase I Trial (CARD-1) for C-CAR011 in Patients with Refractory Diffuse Large B-cell Lymphoma (DLBCL) in China
Source: Cellular Biomedicine Group, Inc.
Cellular Biomedicine Group Inc. (NASDAQ:CBMG)
(“CBMG” or the “Company”), a clinical-stage biomedicine firm engaged in
the development of effective immunotherapies for cancer and stem cell
therapies for degenerative diseases, is pleased to announce the approval
and commencement of patient enrollment in China for its CARD-1 (“CAR-T
Against DLBCL”) Phase I clinical trial utilizing its optimized
proprietary C-CAR011 construct of CD19 chimeric antigen receptor T-cell
(CAR-T) therapy for the treatment of patients with refractory Diffuse
Large B-cell Lymphoma (DLBCL). The CARD-1 trial has begun enrollment
with final data expected to be available in the second half of 2017.
Based on the CARD-1 results, CBMG expects to initiate a larger Phase II
clinical trial as soon as practicable.
“Our
CARD-1 trial represents the first CBMG-sponsored clinical trial after
CBMG’s acquisition of its CAR-T technology and data from the PLA General
Hospital (PLAGH, also known as 301 Hospital) in Beijing. We are proud
of this major corporate milestone where CBMG has taken existing
technology and improved it with proprietary optimization and initiated
new clinical trials in China,” said Tony (Bizuo) Liu, Chief Executive
Officer of CBMG. “We believe we are one of the very few companies that
uniquely possesses internal viral vector production and transduction
capabilities within our own integrated GMP facility. This allows CBMG to
move quickly and efficiently from R&D to manufacturing CAR-T cells
for clinical use.”
According to a recent large,
multi-cohort dataset analysis, patients with refractory DLBCL have
clinical response rates of only 20%-30% with a median overall survival
of approximately six months. These poor refractory DLBCL patient
outcomes represent a significant unmet medical need. CBMG’s CARD-1 Phase
I dose-escalation trial will use the traditional 3x3 design to evaluate
the safety, efficacy and persistence of C-CAR011 in refractory DLBCL
patients.
“DLBCL is the largest subtype of
Non-Hodgkin Lymphoma (NHL), and those refractory patients whose
treatment has failed have limited options and a very poor prognosis
compared to relapsed patients who had previously responded to
treatment,” said Dr. Jianyong Li from Jiangsu Provincial People’s
Hospital in Nanjing China, the Principal Investigator for the CARD-1
trial. “I am excited to be able to participate in the trial of C-CAR011
which may someday provide a treatment option for these refractory
patients.”
“We are very excited as CARD-1
represents the first of a planned series of clinical trials utilizing
CBMG’s optimized CAR-T drug candidates,” said Dr. Yihong Yao, Chief
Scientific Officer of CBMG. “We look forward to announcing additional
trials and CAR-T candidates in the future.”
About the CARD-1 Clinical Trial
CARD-1 is a Phase I single-site, single-arm dose-escalating trial consisting of three patient cohorts using escalating C-CAR011 cell dosing levels with three patients in each cohort. The primary end points are Dose-Limiting Toxicity (DLT) and Treatment Emergent Adverse Events (TEAE). Secondary endpoints will measure Overall Response Rate (Complete plus Partial Responses) at 4 weeks and 12 weeks and Disease Control Rate (Complete plus Partial Responses plus Stable Disease) at 12 weeks according to the International Working Group (IWG) revised criteria. The trial summary is registered with clinicaltrials.gov under the number NCT02976857.
CARD-1 is a Phase I single-site, single-arm dose-escalating trial consisting of three patient cohorts using escalating C-CAR011 cell dosing levels with three patients in each cohort. The primary end points are Dose-Limiting Toxicity (DLT) and Treatment Emergent Adverse Events (TEAE). Secondary endpoints will measure Overall Response Rate (Complete plus Partial Responses) at 4 weeks and 12 weeks and Disease Control Rate (Complete plus Partial Responses plus Stable Disease) at 12 weeks according to the International Working Group (IWG) revised criteria. The trial summary is registered with clinicaltrials.gov under the number NCT02976857.
The trial will be conducted by Dr.
Jianyong Li at the Jiangsu Provincial People’s Hospital in Nanjing
China. The Jiangsu Provincial People’s Hospital (also known as the First
Affiliated Hospital of Nanjing Medical University, Jiangsu Clinical
Medicine Research Institute and the Red Cross Hospital of Jiangsu) was
founded in 1936 and performs medical treatment, provides education, and
conducts advanced research. The hospital has 3,000 beds and over 4,000
employees with total floor space of 3 million square feet covering 50
acres. The Department of Clinical Medicine of Nanjing Medical University
is located inside the hospital, offering clinical medicine doctoral
degree and postdoctoral research programs, with 45 teaching and research
sections and more than 200 professors. The hospital maintains
cooperative relationships with other research hospitals and laboratories
in countries such as the US, Japan, Canada, Australia and Italy.
About C-CAR011
CBMG’s proprietary anti-CD19 chimeric antigen receptor T-cell (CAR-T) construct represents advancement over CBMG’s prior CBM-C19.1 construct. C-CAR011 is entirely engineered and manufactured in CBMG’s own GMP manufacturing facility in China.
CBMG’s proprietary anti-CD19 chimeric antigen receptor T-cell (CAR-T) construct represents advancement over CBMG’s prior CBM-C19.1 construct. C-CAR011 is entirely engineered and manufactured in CBMG’s own GMP manufacturing facility in China.
About Diffuse Large B-Cell Lymphoma (DLBCL)
Diffuse Large B-Cell Lymphoma (DLBCL) is the most common form of Non-Hodgkin Lymphoma (NHL) with DLBCL representing approximately 30% of newly diagnosed NHL cases in the United States and an even higher percentage of newly diagnosed NHL cases in China. DLBCL is an aggressive form of lymphoma that advances quickly and occurs in both men and women although slightly more common in men. The incidence of DLBCL increases with age with most patients over the age of 60. The current treatment options include chemotherapy, anti-CD20 targeted therapy, radiation and stem cell transplantation. However, for patients with refractory DLBCL (failed to respond to treatment) the poor clinical response rates of 20%-30% with median overall survival of approximately 6 months represents a significant unmet medical need.
Diffuse Large B-Cell Lymphoma (DLBCL) is the most common form of Non-Hodgkin Lymphoma (NHL) with DLBCL representing approximately 30% of newly diagnosed NHL cases in the United States and an even higher percentage of newly diagnosed NHL cases in China. DLBCL is an aggressive form of lymphoma that advances quickly and occurs in both men and women although slightly more common in men. The incidence of DLBCL increases with age with most patients over the age of 60. The current treatment options include chemotherapy, anti-CD20 targeted therapy, radiation and stem cell transplantation. However, for patients with refractory DLBCL (failed to respond to treatment) the poor clinical response rates of 20%-30% with median overall survival of approximately 6 months represents a significant unmet medical need.
About Cellular Biomedicine Group (CBMG)
Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of cancer and degenerative diseases. Our immuno-oncology and stem cell projects are the result of research and development by CBMG’s scientists and clinicians from both China and the United States. Our GMP facilities in China, consisting of twelve independent cell production lines, are designed and managed according to both China and U.S. GMP standards. To learn more about CBMG, please visit: www.cellbiomedgroup.com
Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of cancer and degenerative diseases. Our immuno-oncology and stem cell projects are the result of research and development by CBMG’s scientists and clinicians from both China and the United States. Our GMP facilities in China, consisting of twelve independent cell production lines, are designed and managed according to both China and U.S. GMP standards. To learn more about CBMG, please visit: www.cellbiomedgroup.com
Arch Therapeutics to Provide Corporate Update at the 29th Annual Roth Conference on Monday, March 13, 2017
Source: Arch Therapeutics, Inc.
Terrence Norchi, MD, CEO of Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of novel liquid, gel and solid hemostatic and wound care devices, will present a corporate update at the 29th Annual Roth Conference, which will take place from March 12-15, 2017 at The Ritz-Carlton, Laguna Niguel in Dana Point, California.
The presentation is scheduled for Monday, March 13, 2017 at 12:30 PM PT (3:30 PM ET). Dr. Norchi will be available to meet with investors who are registered to attend the conference. If you are an investor and wish to attend the Company's presentation or schedule a meeting, please click the following link: http://www.roth.com/main/page.aspx?PageID=7280.
You may access the live webcast by visiting: http://wsw.com/webcast/roth31/arth. The presentation will be available for download at: http://ir.archtherapeutics.com.
About Arch Therapeutics, Inc.
Arch Therapeutics, Inc. is a medical device company developing a novel approach to stop bleeding (hemostasis) and control leaking (sealant) during surgery and trauma care. Arch is developing products based on an innovative self-assembling materials technology platform with the goal of making surgery and interventional care faster and safer for patients. Arch's flagship development stage product candidates, known as the AC5 Surgical Hemostatic Device™ and AC5 Topical Hemostatic Device™, are being designed to achieve hemostasis during surgical, wound and interventional care.
About Roth Capital Partners, LLC
Roth Capital Partners, LLC (ROTH) is a relationship-driven investment bank focused on serving emerging growth companies and their investors. As a full-service investment bank, ROTH provides capital raising, M&A advisory, analytical research, trading, market-making services and corporate access. Headquartered in Newport Beach, CA, ROTH is privately-held and employee owned, and maintains offices throughout the U.S. For more information on ROTH, please visit www.roth.com.
Terrence Norchi, MD, CEO of Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of novel liquid, gel and solid hemostatic and wound care devices, will present a corporate update at the 29th Annual Roth Conference, which will take place from March 12-15, 2017 at The Ritz-Carlton, Laguna Niguel in Dana Point, California.
The presentation is scheduled for Monday, March 13, 2017 at 12:30 PM PT (3:30 PM ET). Dr. Norchi will be available to meet with investors who are registered to attend the conference. If you are an investor and wish to attend the Company's presentation or schedule a meeting, please click the following link: http://www.roth.com/main/page.aspx?PageID=7280.
You may access the live webcast by visiting: http://wsw.com/webcast/roth31/arth. The presentation will be available for download at: http://ir.archtherapeutics.com.
About Arch Therapeutics, Inc.
Arch Therapeutics, Inc. is a medical device company developing a novel approach to stop bleeding (hemostasis) and control leaking (sealant) during surgery and trauma care. Arch is developing products based on an innovative self-assembling materials technology platform with the goal of making surgery and interventional care faster and safer for patients. Arch's flagship development stage product candidates, known as the AC5 Surgical Hemostatic Device™ and AC5 Topical Hemostatic Device™, are being designed to achieve hemostasis during surgical, wound and interventional care.
About Roth Capital Partners, LLC
Roth Capital Partners, LLC (ROTH) is a relationship-driven investment bank focused on serving emerging growth companies and their investors. As a full-service investment bank, ROTH provides capital raising, M&A advisory, analytical research, trading, market-making services and corporate access. Headquartered in Newport Beach, CA, ROTH is privately-held and employee owned, and maintains offices throughout the U.S. For more information on ROTH, please visit www.roth.com.
Arch Therapeutics, Inc. $6.1 Million Registered Direct Offering
Source: Arch Therapeutics, Inc.
Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), a developer of innovative materials as hemostatic and wound care devices, today announced the pricing of a registered direct offering of 10,166,664 units, each unit consisting of a share of the Company's common stock, and 0.55 of a Series F Warrant ("Series F Warrant") to purchase one share of our common stock for the combined purchase price of $0.60 per unit. The Series F Warrants have an exercise price of $0.75 per share and are exercisable for a period of five years.
The gross proceeds to Arch from this offering are approximately $6.1 million before deducting estimated offering expenses payable by the Company. The offering is expected to close on or about February 24, 2017, subject to customary closing conditions. Approximately $825,000 of the offering proceeds will be used to satisfy our outstanding indebtedness to the Massachusetts Life Sciences Center ("MLSC") under the Life Sciences Accelerator Funding Agreement that we entered into MLSC on September 30, 2013 and amended on September 28, 2016.
The securities described above are being offered by Arch pursuant to a registration statement previously filed with and subsequently declared effective by the Securities and Exchange Commission ("SEC")(File Number 333- 213878) on October 20, 2016. A final prospectus supplement relating to the offering will be filed with the SEC and, once filed, will be available on the SEC's website at http://www.sec.gov.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Arch Therapeutics, Inc.
Arch Therapeutics, Inc. is a medical device company developing a novel approach to stop bleeding (hemostasis) and control leaking (sealant) during surgery and trauma care. Arch is developing products based on an innovative self-assembling materials technology platform with the goal of making surgery and interventional care faster and safer for patients. Arch's flagship development stage product candidates, known as the AC5 Surgical Hemostatic Device™ and AC5 Topical Hemostatic Device™, are being designed to achieve hemostasis during surgical, wound and interventional care.
Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), a developer of innovative materials as hemostatic and wound care devices, today announced the pricing of a registered direct offering of 10,166,664 units, each unit consisting of a share of the Company's common stock, and 0.55 of a Series F Warrant ("Series F Warrant") to purchase one share of our common stock for the combined purchase price of $0.60 per unit. The Series F Warrants have an exercise price of $0.75 per share and are exercisable for a period of five years.
The gross proceeds to Arch from this offering are approximately $6.1 million before deducting estimated offering expenses payable by the Company. The offering is expected to close on or about February 24, 2017, subject to customary closing conditions. Approximately $825,000 of the offering proceeds will be used to satisfy our outstanding indebtedness to the Massachusetts Life Sciences Center ("MLSC") under the Life Sciences Accelerator Funding Agreement that we entered into MLSC on September 30, 2013 and amended on September 28, 2016.
The securities described above are being offered by Arch pursuant to a registration statement previously filed with and subsequently declared effective by the Securities and Exchange Commission ("SEC")(File Number 333- 213878) on October 20, 2016. A final prospectus supplement relating to the offering will be filed with the SEC and, once filed, will be available on the SEC's website at http://www.sec.gov.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Arch Therapeutics, Inc.
Arch Therapeutics, Inc. is a medical device company developing a novel approach to stop bleeding (hemostasis) and control leaking (sealant) during surgery and trauma care. Arch is developing products based on an innovative self-assembling materials technology platform with the goal of making surgery and interventional care faster and safer for patients. Arch's flagship development stage product candidates, known as the AC5 Surgical Hemostatic Device™ and AC5 Topical Hemostatic Device™, are being designed to achieve hemostasis during surgical, wound and interventional care.
Arch Therapeutics Announces Issuance of Method-of-Use Patent Covering Self-Assembling Peptidomimetics
Source: Arch Therapeutics, Inc.
Patent Describes Use of Self-Assembling Peptidomimetics to Create Barriers that Prevent Movement of Bodily Fluids and Contaminants, as well as Other Applications
Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of novel liquid, gel and solid hemostatic and wound care devices, announced that the U.S. Patent and Trademark Office has issued a broad method-of-use patent for products that contain self-assembling peptidomimetics (U.S. Patent number 9,511,113). The patent is assigned to the Massachusetts Institute of Technology (MIT) and Versitech Limited and is licensed exclusively to Arch. Arch is developing products that contain self-assembling materials, such as the AC5™ family of devices, that may provide faster, safer and improved solutions for surgical, wound and interventional care. Arch anticipates that this patent will provide further value and opportunities for its pipeline.
The broad method-of-use claims cover techniques for preventing the loss or unwanted movement of body fluids through the application of products that contain peptidomimetics that self-assemble into barrier structures on tissue. Peptidomimetics, which are synthetic molecules made at least partially from amino acids that do not occur in nature, can mimic peptide structure and function, with potentially more desirable characteristics. Examples of procedures potentially supported by this intellectual property include the use of hemostatic agents to limit or stop bleeding, barrier structures that prevent contamination or infection, sealants to stop leaks, and applications in the wound care and tissue regeneration space.
Dr. Terrence W. Norchi, President and CEO of Arch Therapeutics, said, "We are committed to building and enhancing our portfolio of assets in order to add value to Arch and further protect our products in development and potential pipeline. This patent may offer insight into our future products opportunities."
Dr. Norchi continued, "In the meantime, we continue to make progress with our plans to submit both European and U.S. regulatory filings for AC5 devices, and there has been no new incremental request for information since we completed our clinical trial. We continue to work with our partners to finalize the manufacturing and quality information necessary to support our regulatory filings. We look forward to filing a CE Mark as soon as possible, and we are excited about our recently announced plans and opportunities regarding the U.S. 510(k) pathway."
The patent is expected to further enhance intellectual property protection around potential future products in development. It complements Arch's current intellectual property estate, which includes patents focused on self-assembling peptides made of amino acids that occur in nature and a patent covering peptidomimetic compositions-of-matter.
Arch has filed its own patent applications and, in addition, has worldwide exclusive rights to certain patents and patent applications assigned to MIT and Versitech Limited, the technology transfer company of the University of Hong Kong. The intellectual property estate either assigned to or exclusively licensed by Arch or its wholly owned subsidiary, Arch Biosurgery, Inc., includes 45 patents and pending applications in multiple jurisdictions, including seven issued patents in the U.S. The applications and rights cover self-assembling compositions and methods of making and using such compositions for medical applications, including stopping bleeding; preventing the movement of bodily fluids, contaminants, etc., within or on the human body; preventing adhesions; treatment of leaky or damaged tight junctions; and reinforcement of weak or damaged vessels, such as aneurysms, with patents covering this technology in the U.S., Israel, Europe, Japan, Canada, Australia, Hong Kong and China. Additional patent applications are pending in multiple jurisdictions.
About Arch Therapeutics, Inc.
Arch Therapeutics, Inc. is a medical device company developing a novel approach to stop bleeding (hemostasis) and control leaking (sealant) during surgery and trauma care. Arch is developing products based on an innovative self-assembling peptide technology platform with the goal of making surgery and interventional care faster and safer for patients. Arch's flagship development stage product candidates, known as the AC5 Surgical Hemostatic Device™ and AC5 Topical Hemostatic Device™, are being designed to achieve hemostasis during surgical, wound and interventional care.
Patent Describes Use of Self-Assembling Peptidomimetics to Create Barriers that Prevent Movement of Bodily Fluids and Contaminants, as well as Other Applications
Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of novel liquid, gel and solid hemostatic and wound care devices, announced that the U.S. Patent and Trademark Office has issued a broad method-of-use patent for products that contain self-assembling peptidomimetics (U.S. Patent number 9,511,113). The patent is assigned to the Massachusetts Institute of Technology (MIT) and Versitech Limited and is licensed exclusively to Arch. Arch is developing products that contain self-assembling materials, such as the AC5™ family of devices, that may provide faster, safer and improved solutions for surgical, wound and interventional care. Arch anticipates that this patent will provide further value and opportunities for its pipeline.
The broad method-of-use claims cover techniques for preventing the loss or unwanted movement of body fluids through the application of products that contain peptidomimetics that self-assemble into barrier structures on tissue. Peptidomimetics, which are synthetic molecules made at least partially from amino acids that do not occur in nature, can mimic peptide structure and function, with potentially more desirable characteristics. Examples of procedures potentially supported by this intellectual property include the use of hemostatic agents to limit or stop bleeding, barrier structures that prevent contamination or infection, sealants to stop leaks, and applications in the wound care and tissue regeneration space.
Dr. Terrence W. Norchi, President and CEO of Arch Therapeutics, said, "We are committed to building and enhancing our portfolio of assets in order to add value to Arch and further protect our products in development and potential pipeline. This patent may offer insight into our future products opportunities."
Dr. Norchi continued, "In the meantime, we continue to make progress with our plans to submit both European and U.S. regulatory filings for AC5 devices, and there has been no new incremental request for information since we completed our clinical trial. We continue to work with our partners to finalize the manufacturing and quality information necessary to support our regulatory filings. We look forward to filing a CE Mark as soon as possible, and we are excited about our recently announced plans and opportunities regarding the U.S. 510(k) pathway."
The patent is expected to further enhance intellectual property protection around potential future products in development. It complements Arch's current intellectual property estate, which includes patents focused on self-assembling peptides made of amino acids that occur in nature and a patent covering peptidomimetic compositions-of-matter.
Arch has filed its own patent applications and, in addition, has worldwide exclusive rights to certain patents and patent applications assigned to MIT and Versitech Limited, the technology transfer company of the University of Hong Kong. The intellectual property estate either assigned to or exclusively licensed by Arch or its wholly owned subsidiary, Arch Biosurgery, Inc., includes 45 patents and pending applications in multiple jurisdictions, including seven issued patents in the U.S. The applications and rights cover self-assembling compositions and methods of making and using such compositions for medical applications, including stopping bleeding; preventing the movement of bodily fluids, contaminants, etc., within or on the human body; preventing adhesions; treatment of leaky or damaged tight junctions; and reinforcement of weak or damaged vessels, such as aneurysms, with patents covering this technology in the U.S., Israel, Europe, Japan, Canada, Australia, Hong Kong and China. Additional patent applications are pending in multiple jurisdictions.
About Arch Therapeutics, Inc.
Arch Therapeutics, Inc. is a medical device company developing a novel approach to stop bleeding (hemostasis) and control leaking (sealant) during surgery and trauma care. Arch is developing products based on an innovative self-assembling peptide technology platform with the goal of making surgery and interventional care faster and safer for patients. Arch's flagship development stage product candidates, known as the AC5 Surgical Hemostatic Device™ and AC5 Topical Hemostatic Device™, are being designed to achieve hemostasis during surgical, wound and interventional care.
Arch Therapeutics Reports AC5 Topical Hemostatic Device Successfully Stopped Bleeding in Patients on Antiplatelet Therapy in Recently Completed Clinical Study
Source: Arch Therapeutics, Inc.
Treatment Effect of AC5-Significantly Shortening of Time To Hemostasis vs Control- Was Consistent Whether Patients Were Taking Antiplatelet Therapy or Not
Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of devices for use in controlling bleeding and fluid loss in order to provide faster and safer surgical and interventional care, reports additional positive data in its recently completed single-center, randomized, single-blind prospective clinical study (NCT 02704104) of the AC5 Topical Hemostatic Device™ ("AC5™") in skin lesion patients with bleeding wounds. On August 15, 2016, the Company reported top-line data from the clinical study that indicated that AC5 was safe and that it reduced time to hemostasis in wounds versus controls. Today, the Company released the results of additional analysis of the subgroup of 10 patients who were taking a prescribed antiplatelet medication, commonly known as a blood thinner, such as aspirin, which indicated that AC5 had similar effects for the subgroup of patients taking an antiplatelet agent.
In
particular, in this newly reported analysis of the primary and
secondary outcomes for wounds among patients treated with an
antiplatelet agent, the primary objective of safety throughout the
surgical procedure and until the end of a 30-day follow-up period post
procedure was met and AC5 was well tolerated. Moreover, AC5 shortened
time to hemostasis ("TTH") versus a control whether or not patients were
taking antiplatelet therapy, suggesting that AC5 performance is not
affected by antiplatelet therapy. The reduced median TTH of the AC5
treated wounds versus the control wounds was statistically significant
for both the overall group of 46 patients (p<0.001) and for the
subgroup of 10 patients on antiplatelet therapy (p=0.005). Further, the
median TTH for wounds treated with AC5 was less than 30 seconds for both
the overall study group and for the subset of patients taking
antiplatelet therapy.
Terrence
W. Norchi, MD, President and CEO of Arch Therapeutics, said, "We have
eagerly awaited initial data to support the hypothesis that the
mechanism of action of AC5 is independent of a patient's underlying
bleeding or coagulation status. These results are an important first
step in highlighting an important differentiating feature of AC5 and our
self-assembling peptide technology platform."
Jack
Kelly, MD, Principal Investigator of the study, and a plastic,
reconstructive and aesthetic surgeon and Professor of Surgery at Galway
University Hospital, Galway, Ireland, said, "We have been impressed with
how patients in this study responded to treatment and how easy AC5 was
to use. The favorable safety and efficacy profile of AC5 in the overall
study was supported when looking at the subset of patients taking
antiplatelet therapy, which is particularly noteworthy. Many patients
have perturbed hemostasis pathways, whether from natural disease or the
use of prescribed or over the counter blood thinners, therefore we
always have a concern about more bleeding in these patients. AC5 may
provide their care providers a valuable tool to address those
challenges."
As
previously reported, this first study assessing the safety and
performance of AC5 in humans served to evaluate the safety and
performance of AC5 in patients scheduled to undergo excision of skin
lesions on their trunk or upper limbs. Of the 46 patients enrolled in
the human study, 10 patients were taking an antiplatelet agent and 36
were not. Each patient had two wounds, of which one was treated with AC5
and the other received standard care plus a sham treatment according to
a randomization process. Consequently, each patient served as her/his
own control.
The
study's overall primary objective of safety throughout the surgical
procedure and until the end of a 30-day follow-up period post procedure
was met and AC5 was well tolerated. No serious adverse events were
reported. A secondary endpoint was performance as assessed by time to
hemostasis. The median time to hemostasis of wounds in the AC5 treatment
group was 41% faster than for those in the control group. This result
was statistically significant (p<0.001, Wilcoxon signed rank test).
An additional secondary endpoint of healing of treated wounds was
assessed as measured by the ASEPSIS wound score at Days 7 and 30. The
majority of patients had an ASEPSIS score of 0 in both wounds on both
days, and all AC5-treated wounds healed satisfactorily as per wound
healing scoring criteria.
Previously,
Arch's clinical advisory committee deemed the study results to be
clinically significant and have recommended submitting a manuscript to a
peer-reviewed medical journal for publication. In light of this new
data, the committee added, "This first human study assessing the safety
and performance of AC5 has revealed an impressive and statistically
significant result in patients on an antiplatelet agent, indicating that
it may have broad potential scope in different applications."
The
advisors include Arthur Rosenthal, PhD, Professor of Practice,
Emeritus, Department of Biomedical Engineering, Boston University, and a
former member of Arch's Board of Directors; Steven Schwaitzberg, MD,
Professor and Chairman of the Department of Surgery at the University of
Buffalo's Jacobs School of Medicine and Biomedical Sciences and past
President of the Society of American Gastrointestinal Endoscopic
Surgeons; Paresh Shah, MD, Vice Chair of Surgery, Director of General
Surgery and Professor of Surgery at New York University Langone Medical
Center, New York University Langone School of Medicine; and William
Denman, MD, anesthesiologist at Massachusetts General Hospital, past
Chief Medical Officer of GE Healthcare and past Chief Medical Officer of
Covidien.
The
Company expects to submit further study details and data to a
peer-reviewed journal for publication. The Company also plans to include
data from this trial in its regulatory filings, including in a CE mark
application for AC5, which is currently anticipated to be filed at the
earliest by the end of this year. Arch is currently planning its next
clinical-regulatory steps for both the EU and the US.
The
study, conducted at University College Hospital, Galway, Ireland, was
carried out in collaboration with CÚRAM, Science Foundation Ireland
Centre for Research in Medical Devices and the HRB Clinical Research
Facility based at National University of Ireland Galway.
About Arch Therapeutics, Inc.
Arch
Therapeutics, Inc. is a medical device company developing a novel
approach to stop bleeding (hemostasis) and control leaking (sealant)
during surgery and trauma care. Arch is developing products based on an
innovative self-assembling peptide technology platform to make surgery
and interventional care faster and safer for patients. Arch's flagship
development stage product candidate, known as the AC5 Surgical
Hemostatic Device™, is being designed to achieve hemostasis in surgical
procedures.
About HRB Clinical Research Facility, Galway, Ireland
The
HRB Clinical Research Facility, Galway (CRFG) is a joint venture
between Galway University Hospitals (GUH), Saolta, and National
University of Ireland, Galway (NUIG) and has been in operation since
March 2008. The HRB-CRFG provides the infrastructure, physical space,
facilities, expertise and culture needed to optimally support clinical
research. It focuses on studies aimed at understanding a range of
diseases and speedily translating the knowledge obtained through this
research work into advances in patient care.
About CÚRAM
CÚRAM
is the Science Foundation Ireland Centre for Research in Medical
Devices, based at NUI Galway. Supported by Science Foundation Ireland
(SFI) and industry partners, CÚRAM enhances Ireland's standing as a
major hub for the global medical devices industry. Its goal is to
radically improve quality of life for patients with chronic illness by
developing the next generation of smart, implantable medical devices.
CÚRAM's innovative approach incorporates biomaterials, drug delivery,
cell based technologies, glycosciences and device design to enhance,
develop and validate both traditional and new combinational medical
devices, from molecular design stage to implant manufacturing. CÚRAM's
devices are being developed with strong clinical collaborations to
enable rapid translation of research findings to clinical application.
Key to the approach is the establishment of unique networks of national
and international collaborations, integrating world class clinical,
academic and industrial partners
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