Onconova Therapeutics Regains Rigosertib Rights in Greater China

Source:  Onconova Therapeutics, Inc. 1/23/2020

• Onconova has the rights to rigosertib, its lead Phase 3 drug candidate, in the key pharmaceutical markets of the United States, Europe, and Greater China
• The Company plans to partner certain available territories including Greater China in connection with the anticipated reporting of topline data from the registrational INSPIRE Trial in 1H 2020
• Rigosertib is partnered from agreements in 2019 with Knight Therapeutics for Canada, Specialised Therapeutics for Australia & New Zealand, and with Inceptua Medicines Access for a multi-country pre-approval access program. Onconova partnered rigosertib in 2018 with Pint Pharma for Latin America, and in 2011 with SymBio Pharmaceuticals for Japan & Korea

Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3-stage biopharmaceutical company discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), today announced that it has regained the rights to rigosertib in Greater China.  Onconova regained the rights from HanX Biopharmaceuticals (HanX) as a result of the termination of the Onconova-HanX License Agreement pursuant to its terms due to HanX failing to make required payments under the agreement.  In exchange for transition assistance and upon further regulatory, development and commercial progress in Greater China, HanX may be eligible to receive from Onconova incentive milestones and royalty payments.  The Greater China territory, including mainland China, Hong Kong, Macau and Taiwan, represents one of the key world pharmaceutical markets. 

“We are pleased to regain rigosertib rights for Greater China, and we are encouraged by the opportunity to partner rigosertib in select territories including Greater China as we approach the potential corporate catalyst of topline data for the registrational INSPIRE Trial in 1H 2020,” said Dr. Steven Fruchtman, President and Chief Executive Officer of Onconova.   “We thank HanX for their collaborative efforts to advance rigosertib in this key market including the filing of the rigosertib IND in China.”  Dr. Fruchtman continued, “In 2019, we added partners Knight Therapeutics for Canada, Specialised Therapeutics for Australia & New Zealand, and Inceptua Medicines Access in select countries for pre-approval access to our roster of global corporate partners, joining Pint Pharma for Latin America and SymBio Pharmaceuticals for Japan & Korea.  The United States, Europe, and Greater China represent the major pharmaceutical markets Onconova directly controls heading into INSPIRE data read out.” 

About Onconova Therapeutics, Inc. 

Onconova Therapeutics, Inc. is a Phase 3-stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer, with an initial focus on Myelodysplastic Syndromes (MDS).  Using a proprietary chemistry platform, Onconova has created a pipeline of targeted agents designed to work against specific cellular pathways that are important in cancer cells.  Advanced clinical trials with the Company’s lead compound, rigosertib, are aimed at what the Company believes are unmet medical needs of patients with MDS.  Onconova has conducted trials with two other research compounds and has a pre-clinical program with a CDK4/6 and Ark5 inhibitor, ON 123300.

For more information, please visit http://www.onconova.com. 

About Myelodysplastic Syndromes

Myelodysplastic syndromes (MDS) are conditions that can occur when the blood-forming cells in the bone marrow become dysfunctional and thus produce an inadequate number of circulating blood cells. It is frequently associated with the presence of blasts or leukemic cells in the marrow.  This leads to low numbers of one or more types of circulating blood cells, and to the need for blood transfusions. In MDS, some of the cells in the bone marrow are abnormal (dysplastic) and may have genetic abnormalities associated with them.  Different cell types can be affected, although the most common finding in MDS is a shortage of red blood cells (anemia).  Patients with higher-risk MDS may progress to the development of acute leukemia. 

About Rigosertib

Rigosertib, Onconova’s lead candidate, is a proprietary Phase 3 small molecule.  A key publication in a preclinical model demonstrated rigosertib’s ability to block cellular signaling by targeting RAS effector pathways (Divakar, S.K., et al., 2016: "A Small Molecule RAS-Mimetic Disrupts RAS Association with Effector Proteins to Block Signaling." Cell 165, 643). Onconova is currently in the clinical development stage with oral and IV rigosertib, including clinical trials studying single agent IV rigosertib in second-line higher-risk MDS patients (pivotal Phase 3 INSPIRE trial) and oral rigosertib plus azacitidine in first-line and refractory higher-risk MDS patients (Phase 2).  Patents covering oral and injectable rigosertib have been issued in the US and are expected to provide coverage until at least 2037. 

About the INSPIRE Phase 3 Clinical Trial

The clinical trial INternational Study of Phase 3 IV RigosErtib, or INSPIRE, was finalized following guidance received from the U.S. Food and Drug Administration and European Medicines Agency.  INSPIRE is a global, multi-center, randomized, controlled study to assess the efficacy and safety of IV rigosertib in higher-risk MDS (HR-MDS) patients who had progressed on, failed to respond to, or relapsed after previous treatment with a hypomethylating agent (HMA) within nine cycles over the course of one year after initiation of HMA treatment.  This time frame optimizes the opportunity to respond to treatment with an HMA prior to declaring treatment failure, as per NCCN Guidelines.  Patients are randomized at a 2:1 ratio into two study arms: IV rigosertib plus Best Supportive Care versus Physician's Choice plus Best Supportive Care.  The primary endpoint of INSPIRE is overall survival.  The trial continued beyond the pre-specified interim analysis and is nearing its conclusion. Full details of the INSPIRE trial, such as inclusion and exclusion criteria, as well as secondary endpoints, can be found on clinicaltrials.gov (NCT02562443). 

About IV Rigosertib

The intravenous form of rigosertib has been studied in Phase 1, 2, and 3 clinical trials involving more than 1000 patients, and is currently being evaluated in a randomized Phase 3 international INSPIRE trial for patients with HR-MDS after failure of HMA therapy. 

About Oral Rigosertib 

The oral form of rigosertib was developed to provide a potentially more convenient dosage form for use where the duration of treatment may extend to multiple years. This dosage form may also support combination therapy modalities.  To date, over 400 patients have been dosed with the oral formulation of rigosertib in clinical trials.  Combination therapy of oral rigosertib with azacitidine, the standard of care in HR-MDS, has also been studied. Currently, oral rigosertib is being developed as a combination therapy together with azacitidine for patients with higher-risk MDS who require HMA therapy.  A Phase 1/2 trial of the combination therapy has been fully enrolled, and the updated efficacy and safety data was presented at the ASH 2019 Annual Meeting in December 2019.

Onconova Therapeutics Announces Exclusive License Agreement with Specialised Therapeutics for Rigosertib in Australia and New Zealand

Source:  Onconova Therapeutics, Inc. 12/18/19

• Specialised Therapeutics receives exclusive license to commercialize rigosertib in Australia and New Zealand
• Onconova to be eligible to receive up to US $30.4 million in clinical, regulatory, and sales-based milestones and tiered double-digit royalties

Onconova Therapeutics, Inc. (NASDAQ: ONTX) (“Onconova”), a Phase 3-stage biopharmaceutical company discovering and developing novel products to treat cancer, with a focus on myelodysplastic syndromes (MDS), today announced it has entered into a Distribution, License, and Supply Agreement whereby Specialised Therapeutics Asia (“STA”) shall have the exclusive rights to commercialize rigosertib in Australia and New Zealand.  In addition, Onconova may be entitled to receive clinical, regulatory, and sales-based milestone payments up to US $30.4 million and tiered double-digit royalties on net sales.

“We are pleased to partner with Specialised Therapeutics Asia, which has a strong track record of commercializing new products in oncology and hematology across Australia and New Zealand,” said Dr. Steven Fruchtman, President and Chief Executive Officer of Onconova.  “We look forward to working together and, pending a successful readout of the ongoing INSPIRE Trial, potentially providing rigosertib as a new therapeutic option for patients diagnosed with MDS.”

STA Chief Executive Officer, Mr. Carlo Montagner, said that “patients with high-risk MDS have limited treatment options following currently available first-line treatment. There is no currently approved treatment following failure of standard chemotherapy with hypomethylating agents. Patients are left with the option of entering clinical trials, if available, or supportive care,” he said. “If approved, rigosertib would address an unmet medical need and may be a valuable inclusion to the STA therapeutic portfolio. We are delighted to enter into this collaboration with Onconova and look forward to the results of the ongoing phase 3 INSPIRE Trial of intravenous (IV) rigosertib.”

About Myelodysplastic Syndromes

MDS is a group of blood disorders that affect bone marrow function, whereby the bone marrow cells appear dysplastic and their capacity to produce cells is defective.  As a result, patients with MDS have low blood cell counts and require frequent blood transfusions.  In approximately one-third of patients, higher-risk MDS can progress to acute myelogenous leukemia (AML).

About Rigosertib

Rigosertib, Onconova’s lead candidate, is a proprietary Phase 3 small molecule.  A key publication in a preclinical model described rigosertib’s ability to block cellular signaling by targeting RAS effector pathways (Divakar, S.K., et al., 2016: "A Small Molecule RAS-Mimetic Disrupts RAS Association with Effector Proteins to Block Signaling." Cell 165, 643). Onconova is currently in the clinical development stage with oral and IV rigosertib, including clinical trials studying single agent IV rigosertib in second-line higher-risk MDS patients (pivotal Phase 3 INSPIRE Trial) and oral rigosertib plus azacitidine in first-line and refractory higher-risk MDS patients (Phase 2).  Patents covering oral and injectable rigosertib have been issued in the US and are expected to provide coverage until at least 2037. 

About the INSPIRE Phase 3 Clinical Trial

The clinical trial INternational Study of Phase 3 IV RigosErtib, or INSPIRE, was finalized following guidance received from the U.S. Food and Drug Administration and European Medicines Agency.  INSPIRE is a global, multi-center, randomized, controlled study to assess the efficacy and safety of IV rigosertib in higher-risk MDS (HR-MDS) patients who had progressed on, failed to respond to, or relapsed after previous treatment with a hypomethylating agent (HMA) within nine cycles over the course of one year after initiation of HMA treatment.  This time-frame optimizes the opportunity to respond to treatment with an HMA prior to declaring treatment failure, as per NCCN Guidelines.  Patients are randomized at a 2:1 ratio into two study arms: IV rigosertib plus Best Supportive Care versus Physician's Choice plus Best Supportive Care.  The primary endpoint of INSPIRE is overall survival.  The trial continued beyond the pre-specified interim analysis and is nearing its conclusion. Full details of the INSPIRE trial, such as inclusion and exclusion criteria, as well as secondary endpoints, can be found on clinicaltrials.gov (NCT02562443). 

About Onconova Therapeutics, Inc. 

Onconova Therapeutics, Inc. is a Phase 3-stage biopharmaceutical company discovering and developing novel small molecule drug candidates to treat cancer, with a focus on Myelodysplastic Syndromes (MDS).  Using a proprietary chemistry platform, Onconova has created a pipeline of targeted agents designed to work against specific cellular pathways that are important in cancer cells.  Advanced clinical trials with the Company’s lead compound, rigosertib, are aimed at what the Company believes are unmet medical needs of patients with MDS.  Onconova has conducted trials with two other research compounds and has a pre-clinical program with a CDK4/6 and Ark5 inhibitor, ON 123300. 

For more information, please visit http://www.onconova.com. 

About Specialised Therapeutics Asia

Headquartered in Singapore, Specialised Therapeutics Asia Pte Ltd (STA) is an international biopharmaceutical company established to commercialise new therapies and technologies to patients throughout South East Asia, as well as in Australia and New Zealand. STA and its regional affiliates collaborate with leading global pharmaceutical and diagnostic companies to bring novel, innovative and life-changing healthcare solutions to patients affected by a range of diseases. Its mission is to provide therapies where there is an unmet need. The company’s broad therapeutic portfolio currently includes novel agents in oncology, haematology, neurology, ophthalmology and supportive care.

Additional information can be found at www.stbiopharma.com.

Onconova Therapeutics and Pint Pharma Announce Brazilian Health Authority Approval for Initiating INSPIRE Trial with Intravenous Rigosertib in Higher-Risk Myelodysplastic Syndromes in Brazil

Source:  Onconova Therapeutics, Inc. 12/17/19

• The INSPIRE Trial enters the final stage of enrollment after surpassing 90% of the required number of randomized patients in November 2019 
• Pint Pharma Facilitates Opening of Phase 3 INSPIRE Trial in Brazil
• Topline Data Expected in First Half 2020

Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), and Pint Pharma, a European-based pharmaceutical company focused on the development, registration and commercialization of specialty-based treatments for the Latin American market, today announced the receipt of approval from the Brazilian Health authority to initiate the INSPIRE Trial in Brazil with intravenous rigosertib in Higher-Risk MDS (HR-MDS).  In November 2019 enrollment in the INSPIRE Trial surpassed 90% percent of the required enrollment, and the Company continues to anticipate reporting topline data in the first half of 2020, following full enrollment and reaching the number of required survival events.

“As we enter the final stage of enrollment of the INSPIRE Trial, we thank our corporate partner Pint Pharma for their collaboration in opening the study in Brazil,” said Dr. Steven Fruchtman, President and CEO of Onconova Therapeutics, Inc. “The INSPIRE Trial surpassed 90% percent of the required enrollment in November 2019 and we expect the addition of up to 16 clinical trial sites in Brazil will provide further momentum to our anticipated reporting of topline data in the first half of 2020, following full enrollment and reaching the number of required survival events.”

“We are excited to collaborate with Onconova in opening new clinical sites and look forward to the recruitment of eligible patients for the INSPIRE Trial in Brazil,” said David Munoz, Chief Executive Officer of Pint Pharma. He added, “We are also pleased that local physicians will gain invaluable experience with rigosertib by their participation on the INSPIRE Trial.”

Dr. Ric Woodman, Chief Medical Officer of Onconova, is working closely with Dr. Valnei Canutti, Chief Scientific Officer of Pint. Dr. Woodman commented, “There is a great unmet medical need and interest to conduct studies in patients with HR-MDS in this geographical region. I look forward to a productive collaboration with Pint Pharma and working with Dr. Canutti, an expert in conducting trials in Brazil as well as an expert in MDS.”

Dr. Canutti added, “We anticipate meaningful contributions from Brazil to accrual to the INSPIRE Trial and are excited about receiving health authority approval to initiate INSPIRE in Brazil. There are significant numbers of patients with HR-MDS in Brazil with no approved approach following failure of the standard of care azacitidine. We at Pint, in collaboration with our partner Onconova, look forward to Brazil’s contributions to complete accrual to this important pivotal global trial.”

About Pint Pharma

Pint Pharma is devoted to the development, registration, and commercialization of specialty-based treatments. Pint Pharma benefits from leaders with extensive experience in the pharmaceutical sector and who are based strategically throughout Latin America and Europe. Pint Pharma has a long track record of developing strong relationships with global pharmaceutical and healthcare companies. Pint Pharma strives to be the first Pan-Latin American provider of innovative and high value-added treatments within Rare Diseases, Specialty Care, and Oncology.

About Onconova Therapeutics, Inc. 

Onconova Therapeutics, Inc. is a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with an initial focus on Myelodysplastic Syndromes (MDS).  Using a proprietary chemistry platform, Onconova has created a pipeline of targeted agents designed to work against specific cellular pathways that are important in cancer cells.  Advanced clinical trials with the Company’s lead compound, rigosertib, are aimed at what the Company believes are unmet medical needs of patients with MDS.  Onconova has conducted trials with two other research compounds and has a pre-clinical program with a CDK4/6 and Ark5 inhibitor, ON 123300.

For more information, please visit http://www.onconova.com. 

About Myelodysplastic Syndromes

Myelodysplastic syndromes (MDS) are conditions that can occur when the blood-forming cells in the bone marrow become dysfunctional and thus produce an inadequate number of circulating blood cells. It is frequently associated with the presence of blasts or leukemic cells in the marrow.  This leads to low numbers of one or more types of circulating blood cells, and to the need for blood transfusions. In MDS, some of the cells in the bone marrow are abnormal (dysplastic) and may have genetic abnormalities associated with them.  Different cell types can be affected, although the most common finding in MDS is a shortage of red blood cells (anemia).  Patients with higher-risk MDS may progress to the development of acute leukemia. 

About Rigosertib

Rigosertib, Onconova’s lead candidate, is a proprietary Phase 3 small molecule.  A key publication in a preclinical model demonstrated rigosertib’s ability to block cellular signaling by targeting RAS effector pathways (Divakar, S.K., et al., 2016: "A Small Molecule RAS-Mimetic Disrupts RAS Association with Effector Proteins to Block Signaling." Cell 165, 643). Onconova is currently in the clinical development stage with oral and IV rigosertib, including clinical trials studying single agent IV rigosertib in second-line higher-risk MDS patients (pivotal Phase 3 INSPIRE trial) and oral rigosertib plus azacitidine in first-line and refractory higher-risk MDS patients (Phase 2).  Patents covering oral and injectable rigosertib have been issued in the US and are expected to provide coverage until at least 2037. 

About the INSPIRE Phase 3 Clinical Trial

The clinical trial INternational Study of Phase 3 IV RigosErtib, or INSPIRE, was finalized following guidance received from the U.S. Food and Drug Administration and European Medicines Agency.  INSPIRE is a global, multi-center, randomized, controlled study to assess the efficacy and safety of IV rigosertib in higher-risk MDS (HR-MDS) patients who had progressed on, failed to respond to, or relapsed after previous treatment with a hypomethylating agent (HMA) within nine cycles over the course of one year after initiation of HMA treatment.  This time frame optimizes the opportunity to respond to treatment with an HMA prior to declaring treatment failure, as per NCCN Guidelines.  Patients are randomized at a 2:1 ratio into two study arms: IV rigosertib plus Best Supportive Care versus Physician's Choice plus Best Supportive Care.  The primary endpoint of INSPIRE is overall survival.  The trial continued beyond the pre-specified interim analysis and is nearing its conclusion. Full details of the INSPIRE Trial, such as inclusion and exclusion criteria, as well as secondary endpoints, can be found on clinicaltrials.gov (NCT02562443). 

About IV Rigosertib

The intravenous form of rigosertib has been studied in Phase 1, 2, and 3 clinical trials involving more than 1000 patients, and is currently being evaluated in a randomized Phase 3 international INSPIRE trial for patients with HR-MDS after failure of HMA therapy. 

About Oral Rigosertib 

The oral form of rigosertib was developed to provide a potentially more convenient dosage form for use where the duration of treatment may extend to multiple years. This dosage form may also support combination therapy modalities.  To date, over 400 patients have been dosed with the oral formulation of rigosertib in clinical trials.  Combination therapy of oral rigosertib with azacitidine, the standard of care in HR-MDS, has also been studied. Currently, oral rigosertib is being developed as a combination therapy together with azacitidine for patients with higher-risk MDS who require HMA therapy.  A Phase 1/2 trial of the combination therapy has been fully enrolled, and efficacy and safety data was presented at The American Society of Hematology (ASH) Annual Meeting in December 2019.

BioSig to Commence Patient Cases at Mayo Clinic

Source:  BioSig Technologies, Inc. 1/16/2020

Second institution to begin patient enrollments with PURE EP(TM) System

BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company developing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that the Company installed its PURE EP(tm) System at Mayo Clinic in Florida.

Mayo Clinic is the second institution to conduct patient cases under BioSig’s clinical trial titled “Novel Cardiac Signal Processing System for Electrophysiology Procedures (PURE EP 2.0 Study)”. Patient enrollments are due to begin mid-January 2020. Texas Cardiac Arrhythmia Research Foundation (TCARF) in Austin, Texas, was the first institution to conduct patient cases under the clinical trial in the fourth quarter of 2019. 

The Shareholder Letter issued by the Company on November 14, 2019 announced several upcoming installations of the Company’s PURE EP^TM System. The Company believes that trial data may play an important role in advancing broader commercial adoption across the universe of medical centers providing catheter ablation treatments.

About BioSig Technologies
BioSig Technologies is a medical technology company developing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace (www.biosig.com).

The Company’s first product, PURE EP^TM System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

 

BioSig Awarded Additional US Patent Claims for its PURE EP(TM) System

Source:  BioSig Technologies, Inc. 1/14/2020

• Company allowed a fifth utility patent
• Claims address methods for removing voltage offset from biomedical signals
• Eleven additional patent applications covering PURE EP^TM System are currently pending

BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company developing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that the US Patent Office allowed a fifth utility patent covering its PURE EP^TM System. The recently allowed patent application number 16/195,562 entitled "APPARATUS AND METHODS FOR REMOVING A LARGE-SIGNAL VOLTAGE OFFSET FROM A BIOMEDICAL SIGNAL" was filed on November 19, 2018. The claims address methods for removing a voltage offset from a biomedical signal, such as low amplitude cardiac signals during an ablation procedure in the presence of noise.

The allowed patent application complements BioSig’s expanding patent portfolio, which now includes five allowed/issued patents. Eleven additional worldwide utility patent applications are pending covering various aspects of its PURE EP^TM System for recording, measuring, calculating and displaying of electrocardiograms during cardiac ablation procedures. BioSig also has 21 allowed/issued worldwide design patents, which cover various features of its display screens and graphical user interface for enhanced visualization of biomedical signals. 

"We are pleased to announce this newest patent allowance, which further acknowledges the novelty of our advanced biomedical signal processing technology,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.

The PURE EP^TM System is indicated as a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory under the supervision of licensed healthcare practitioners who are responsible for interpreting the data.

About BioSig Technologies
BioSig Technologies is a medical technology company developing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace (www.biosig.com). Led by a proven management team and a veteran Board of Directors, BioSig Technologies is preparing to commercialize its PURE EP^TM System. The technology has been developed to address an unmet need in a large and growing market.

The Company’s first product, PURE EP^TM System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. The system is indicated for use under the supervision of licensed healthcare practitioners who are responsible for interpreting the data. This novel cardiac signal acquisition and display system is engineered to assist electrophysiologists in clinical decision-making during electrophysiology procedures in patients with abnormal heart rates and rhythms. BioSig’s ultimate goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and potentially deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and received FDA 510(k) clearance for the PURE EP^TM System in August 2018.

BioSig Technologies Announces New Collaboration on Development of Artificial Intelligence Solutions in Healthcare

Source:  BioSig Technologies, Inc. 12/3/19

·The Company partners with Reified Capital, a provider of advanced artificial intelligence-focused technical advisory services to the private sector

·Collaboration to focus on machine learning and artificial intelligence solutions for healthcare

·Initial solutions to be centered on BioSig’s core competencies in electrophysiology 

BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company developing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that the Company entered into a technical collaboration with Reified Capital, a provider of advanced artificial intelligence-focused technical advisory services to the private sector. Reified was co-founded by Dr. Alexander D. Wissner-Gross and Timothy M. Sullivan, the founders of Gemedy.

The new collaboration with Cambridge, Massachusetts-based Reified will focus on developing a foundational artificial intelligence platform on the basis of integrated healthcare datasets, beginning with ECG and EEG data acquired by BioSig’s first product, PURE EP(tm) System - a novel real-time signal processing platform engineered to provide electrophysiologists with high fidelity cardiac signals. Electrophysiology focused technological solutions developed under the terms of this collaboration will be integrated into the PURE EP(tm) technology platform. Reified is led by Harvard- and MIT-trained computer scientist and physicist Dr. Wissner-Gross, an award-winning computer scientist, physicist, entrepreneur and author. Technical expertise that the Reified team is planning to bring to the project includes data analysis, algorithmic modeling and development.

“Integration of AI can open new avenues for improved diagnosis and more effective therapy delivery for bioelectronic medicine in particular and healthcare in general. We are thrilled to partner with Alex and his outstanding team, and look forward to working with them on developing world-class artificial intelligence and machine learning solutions, which, we believe, will benefit a worldwide physician audience,” commented Kenneth L Londoner, Chairman and CEO of BioSig Technologies, Inc.

“The application of modern AI and machine learning techniques to electrophysiology presents one of the most promising healthcare opportunities of our time,” said Dr. Wissner-Gross. “We look forward to our forthcoming collaboration with BioSig Technologies.”

On November 21, 2019 the Company announced that it commenced patient enrollment in its first clinical trial for the PURE EP(tm) System.

About Reified Capital
Reified Capital, LLC is a provider of advanced artificial intelligence-focused technical advisory services to the private sector. Reified’s areas of expertise include machine learning, data analysis, modeling and simulation, cybersecurity, knowledge management, cyber-physical systems, and autonomous systems.

About BioSig Technologies
BioSig Technologies is a medical technology company developing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace (www.biosig.com). Led by a proven management team and a veteran Board of Directors, BioSig Technologies is preparing to commercialize its PURE EP(tm) System. The technology has been developed to address an unmet need in a large and growing market.

The Company’s first product, PURE EP(tm) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. The system is indicated for use under the supervision of licensed healthcare practitioners who are responsible for interpreting the data. This novel cardiac signal acquisition and display system is engineered to assist electrophysiologists in clinical decision-making during electrophysiology procedures in patients with abnormal heart rates and rhythms. BioSig’s ultimate goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and potentially deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and received FDA 510(k) clearance for the PURE EP(tm) System in August 2018.

BioSig Technologies Signs Three New Licensing Agreements with Mayo Clinic

Source:  BioSig Technologies, Inc. 11/26/19

·New areas of collaboration identified between Mayo Clinic and BioSig

·Focus on previously untapped arrhythmia treatments

·Additional development areas covering novel therapies for autonomic nervous system disease 

BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company developing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that the Company and its majority-owned subsidiary signed three new patent and know-how license agreements with Mayo Foundation for Medical Education and Research. 

Under the terms of the newly reached agreements the Company plans to establish a new product pipeline to complement more advanced features of BioSig’s first product, PURE EP^TM System, and develop solutions for novel ways to treat autonomic nervous system disease. The new R&D pipeline includes hardware, software and algorithmic solutions to be integrated into PURE EP^TM platform technology. BioSig intends to take the licensed intellectual properties and products, which have been developed by Mayo Clinic over the last decade, through FDA approval, manufacturing, and commercialization. The development program will be run under the leadership of Samuel J. Asirvatham, M.D., Mayo Clinic’s Vice-Chair of Innovation and Medical Director, Electrophysiology Laboratory.

“Sustainable innovation in medicine goes beyond individual products and entails consistent approach to improving the way therapies are delivered. A significant part of our R&D efforts is dedicated to basic science to advance understanding of arrhythmia origination and analysis of the spectrum of other conditions which often accompany heart disease. Mayo Clinic’s mission to providing the best care through integrated clinical practice, research and education deeply resonates with BioSig’s own mission to lead through innovation in bioelectronic medicine, and we are pleased to unveil this new, exciting, chapter in our Company’s development,” commented Kenneth L Londoner, Chairman and CEO of BioSig Technologies, Inc.

“Development of leading-edge therapeutic solutions requires profound knowledge of the leading academic institutions and commitment and dedication of the industry. As part of the growing relationship between physicians at Mayo Clinic and BioSig, my colleagues and I look forward to contributing to the success of the new projects,” said Samuel Asirvatham, M.D., Vice Chair, Innovation and Medical Director, Electrophysiology Laboratory, Mayo Clinic, Rochester, MN.

The Company signed a 10-year collaboration agreement with Mayo Clinic in March 2017.  On November 21, 2019 the Company announced that it commenced patient enrollment in its first clinical trial for the PURE EP^TM System.

Mayo Clinic and Dr. Asirvatham have a financial interest in the technology referenced in this news release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.

About BioSig Technologies
BioSig Technologies is a medical technology company developing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace (www.biosig.com). Led by a proven management team and a veteran Board of Directors, BioSig Technologies is preparing to commercialize its PURE EP^TM  System. The technology has been developed to address an unmet need in a large and growing market.

The Company’s first product, PURE EP^TM System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. The system is indicated for use under the supervision of licensed healthcare practitioners who are responsible for interpreting the data. This novel cardiac signal acquisition and display system is engineered to assist electrophysiologists in clinical decision-making during electrophysiology procedures in patients with abnormal heart rates and rhythms. BioSig’s ultimate goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and potentially deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and received FDA 510(k) clearance for the PURE EP^TM System in August 2018.

BioSig Commences Clinical Trial Enrollment for PURE EP System

Source:  BioSig Technologies, Inc. 11/21/19

BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company developing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that the Company commenced its first clinical trial for its PURE EP™ System.

Texas Cardiac Arrhythmia Research Foundation (TCARF) in Austin, Texas, is the first institution to conduct patient cases under the clinical trial titled, “Novel Cardiac Signal Processing System for Electrophysiology Procedures (PURE EP 2.0 Study)”. Eight patient enrollments were achieved during the first week of the trial. The data collected during the trial is planned to be submitted for abstract consideration at leading industry events throughout 2020, including The Heart Rhythm Scientific Sessions in May 2020.

“Our first clinical trial is an inflection point for our Company, and we are pleased to initiate it with Texas Cardiac Arrhythmia Institute at St. David’s Hospital in Austin, Texas,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.

The Shareholder Letter issued by the Company on November 14, 2019 announced several upcoming installations of the Company’s PURE EP(tm) System, including Mayo Clinic Jacksonville, FL, which is also expected to take part in the clinical trial. This allows the Company to commercialize its product in the rapidly growing $4.6 billion electrophysiology market, and the Company believes trial data may play an important role in advancing broader commercial adoption across the universe of medical centers providing catheter ablation treatments.

About BioSig Technologies
BioSig Technologies is a medical technology company developing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace (www.biosig.com). Led by a proven management team and a veteran Board of Directors, BioSig Technologies is preparing to commercialize its PURE EP^TM  System. The technology has been developed to address an unmet need in a large and growing market.

The Company’s first product, PURE EP^TM System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. The system is indicated for use under the supervision of licensed healthcare practitioners who are responsible for interpreting the data. This novel cardiac signal acquisition and display system is engineered to assist electrophysiologists in clinical decision-making during electrophysiology procedures in patients with abnormal heart rates and rhythms. BioSig’s ultimate goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and potentially deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and received FDA 510(k) clearance for the PURE EP^TM System in August 2018.

Exicure Announces First Neurological Development Program in Friedreich’s Ataxia and Expands Scientific Advisory Board

Source:  Exicure, Inc. 12/16/19

 - Exicure to collaborate with Friedreich’s Ataxia Research Alliance (FARA)

- Hank Paulson, MD, PhD and Susan Perlman, MD, added to Scientific Advisory Board

Exicure, Inc. (NASDAQ:XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA™) technology, today announced Friedreich’s ataxia (FA) as the therapeutic indication for the company’s first neurology development program. Exicure also announced the expansion of its Scientific Advisory Board. 

“Over the past year Exicure has developed extensive preclinical data supporting the development of our SNAs for neurological disorders. We’re eager to evaluate our technology for this important unmet medical need,” said David Giljohann, PhD, Exicure’s chief executive officer. “We are also pleased to add the experience and team from the Friedreich’s Ataxia Research Alliance (FARA),” added Dr. Giljohann.

Patients living with FA experience a devastating and progressive loss of neurological function. There are no approved therapies for FA. Exicure’s FA program will be designed and developed with guidance from and in collaboration with FARA.

"FA is a rare, progressive and life-shortening disease, and there is a critical need for effective treatments," explained FARA's Chief Executive Officer, Jennifer Farmer. "Exicure’s SNA technology is unique in its ability to target the affected gene in FA. FARA has championed collaborative approaches to drug development, and we’re thrilled to work with Exicure as they develop their genetically targeted therapeutic candidate.”

Exicure expects IND-enabling work to begin in 2020. Exicure’s preclinical data in rodents and non-human primates showed distribution of SNAs to all brain regions following intrathecal administration, including those relevant in FA. Additional preclinical rodent data, in a head-to-head comparison with an FDA-approved oligonucleotide, nusinersen, showed improved potency in mice when put into an SNA format.

Exicure also is announcing the expansion of the company’s Scientific Advisory Board to include neurology experts Dr. Susan Perlman, MD, Professor of Neurology at University of California Los Angeles and Medical Director for the National Ataxia Foundation and Dr. Hank Paulson, MD, PhD, Lucile Groff Professor of Neurology for Alzheimer's Disease and Related Disorders in the Department of Neurology at the University of Michigan.

“We are pleased to bring together this fantastic group of patient advocates, medical leaders, and disease experts to join the Exicure team in our mission to launch a program in Friedreich’s ataxia,” Dr. Giljohann concluded.

About Friedreich’s Ataxia (FA)
FA is a rare, degenerative, life-shortening neuro-muscular disorder that affects children and adults, and involves the loss of strength and coordination usually leading to wheelchair use; diminished vision, hearing and speech; scoliosis (curvature of the spine); increased risk of diabetes; and a life-threatening heart condition. There are no FDA-approved treatments. An estimated 5,000 patients in the US and 15,000 patients worldwide are affected by FA.

About FARA
The Friedreich's Ataxia Research Alliance (FARA) is a 501(c)(3), non-profit, charitable organization dedicated to accelerating research leading to treatments and a cure for Friedreich's ataxia. www.CureFA.org

About Exicure, Inc.
Exicure, Inc. is a clinical-stage biotechnology company developing therapeutics for immuno-oncology, inflammatory diseases and genetic disorders based on our proprietary Spherical Nucleic Acid, or SNA technology. Exicure believes that its proprietary SNA architecture has distinct chemical and biological properties that may provide advantages over other nucleic acid therapeutics and may have therapeutic potential to target diseases not typically addressed with other nucleic acid therapeutics. Exicure's lead program is in a Phase 1b/2 trial in patients with advanced solid tumors. Exicure is based outside of Chicago, IL and in Cambridge, MA.
For more information, visit Exicure’s website at www.exicuretx.com.

Exicure Reports Activity of AST-008 in Patients with Merkel Cell Carcinoma and Will Enroll Patients in Phase 2 Study

Source:  Exicure, Inc. 12/11/19

- Phase 1b/2 dose escalation trial of AST-008 shows tolerability of Exicure drug candidate

- Preliminary data show signs of activity in patients with Merkel cell carcinoma

- Exicure to proceed to Phase 2 study in Merkel cell carcinoma

Exicure, Inc. (NASDAQ:XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA™) technology, today announced an update from its Phase 1b/2 trial with AST-008 in patients with solid tumors. AST-008 is an investigational SNA consisting of toll-like receptor 9 (TLR9) agonists designed for immuno-oncology application, and is being evaluated in combination with pembrolizumab in patients with solid tumors.

“We’re very pleased with the preliminary data generated so far in our ongoing Phase 1b/2 trial and we look forward to enrolling patients in the Phase 2 portion of the trial,” said Dr. David Giljohann, CEO of Exicure. “Based on these results, we are considering adding additional cohorts to the trial in other cancers where AST-008 may have benefit,” concluded Dr. Giljohann. 

The primary objective of the dose escalation portion of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AST-008 alone and in combination with pembrolizumab, and to produce a recommended Phase 2 dose. Fourteen patients have been enrolled and dosed with AST-008. No treatment-related serious adverse events or dose-limiting toxicities have been observed. The fifth and final dose escalation cohort is now open and enrolling.

The study has enrolled five melanoma patients, four Merkel cell carcinoma (MCC) patients, two cutaneous squamous cell carcinoma patients, two head and neck squamous cell carcinoma patients, and one mucosal melanoma patient. Prior to enrolling, most patients had progressive disease on anti-PD-(L)1 antibodies. 

Available data show:

• AST-008 administration, alone or in combination with pembrolizumab, produced cytokine and chemokine expression and immune cell activation in patient blood indicative of desired immune activation.
• Of the 4 MCC patients, one patient, which had previously progressed on anti-PD-1 antibody therapy, has confirmed stable disease with decreased target lesion diameters for a period in excess of twelve weeks, while a second MCC patient experienced a target lesion complete response and a confirmed overall partial response longer than 24 weeks.
• Nine patients had progressive disease, two patients have not yet been evaluated and one is not evaluable.

“The initial results are highly encouraging and warrant expansion of the trial, and I'm looking forward to participating,” stated Dr. Steven O’Day, Executive Director of the John Wayne Cancer Institute and Cancer Clinic, and a principal investigator on the study.

Detailed results are expected to be presented at major upcoming oncology meetings. Based on these early results, showing positive biomarker data and initial tumor responses, Exicure anticipates enrolling MCC patients, which have previously failed anti PD-1/PD-L1 therapy, in its Phase 2 study during the first quarter of 2020.

About Exicure, Inc. Exicure, Inc. is a clinical-stage biotechnology company developing therapeutics for immuno-oncology, inflammatory diseases and genetic disorders based on our proprietary Spherical Nucleic Acid, or SNA technology. Exicure believes that its proprietary SNA architecture has distinct chemical and biological properties that may provide advantages over other nucleic acid therapeutics and may have therapeutic potential to target diseases not typically addressed with other nucleic acid therapeutics. Exicure's lead program is in a Phase 1b/2 trial in patients with advanced solid tumors. Exicure is based outside of Chicago, IL and in Cambridge, MA.
For more information, visit Exicure’s website at www.exicuretx.com.