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BioSig Technologies, Inc. (BSGM)

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  • GlobeNewswire

    SORRENTO THERAPEUTICS AND VIRALCLEAR ENTER INTO AGREEMENT TO EXPLORE THE COMBINATION OF ANTIBODY AND ANTIVIRAL ASSETS AGAINST COVID-19

    Westport, CT, Sept. 30, 2020 (GLOBE NEWSWIRE) -- * Sorrento to initiate testing with a selection of its agents in combination with ViralClear’s anti-viral compound for possible synergistic anti-viral effect against SARS-CoV-2 in the preclinical model of Golden Syrian hamster. * ViralClear to contribute its oral antiviral merimepodib (IMPDH inhibitor) which is currently in a Phase 2 trial in combination with remdesivir to treat COVID-19. * Sorrento to initially make available STI-1400 neutralizing antibody candidate for testing. ViralClear Pharmaceuticals, Inc. (Nasdaq BSGM) and Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced the companies are exploring the synergistic potential of small molecules and antibodies combination therapies against COVID-19.In general, multi-modal approaches are considered the most likely to succeed anti-viral strategies. Even with highly effective stand-alone therapies, a synergistic combination can be pursued to help reduce the effective dose needed of each individual agent and aim to ensure maximum effect. The agreement between ViralClear Pharmaceuticals, Inc. (Parent company BioSig Technologies, Inc. Nasdaq: BSGM), and Sorrento Therapeutics will allow for testing of merimepodib with neutralizing antibodies in the Golden Syrian hamster model of COVID-19. The study will look for synergy at the effective doses between the two drugs already in human clinical trials and will try to specifically demonstrate that the combined benefits in strengthening and accelerating viral clearance exceed what each drug could deliver by itself.Pending the outcome of these studies, the results might be presented to the FDA to support the initiation of a human clinical trial of the drug combination.About ViralClear Pharmaceuticals and Merimepodib BioSig’s Technologies, Inc (Nasdaq: BSGM  www.biosig.com) subsidiary, ViralClear Pharmaceuticals, Inc. (ViralClear), is seeking to develop a novel pharmaceutical called merimepodib to treat patients with COVID-19. Merimepodib is intended to be orally administered, and has demonstrated broad-spectrum in vitro antiviral activity, including strong activity against SARS-CoV-2 in cell cultures. Merimepodib was previously in development as a treatment for chronic hepatitis C and psoriasis by Vertex Pharmaceuticals Incorporated (Vertex), with 12 clinical trials (7 in phase 1 and 5 in phase 2) with over 400 subjects and patients and an extensive preclinical safety package was completed. A manuscript titled, “The IMPDH inhibitor merimepodib provided in combination with the adenosine analogue Remdesivir reduces SARS-CoV-2 replication to undetectable levels in vitro”, was submitted to an online peer-reviewed life sciences journal. This manuscript is authored by Natalya Bukreyeva, Rachel A. Sattler, Emily K. Mantlo, John T. Manning, Cheng Huang and Slobodan Paessler of the UTMB Galveston National Laboratory and Dr. Jerome Zeldis of ViralClear as a corresponding author. This article highlights pre-clinical data generated under contract with Galveston National Laboratory at The University of Texas Medical Branch. About Sorrento Therapeutics, Inc.  Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers. Sorrento's multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies ("G-MAB™ library"), clinical stage immuno-cellular therapies ("CAR-T", "DAR-T"), antibody-drug conjugates ("ADCs"), and clinical stage oncolytic virus ("Seprehvir®", “Seprehvec™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIDTRAP™, ACE-MAB™, COVI-MAB™, COVI-GUARD™, COVI-SHIELD™ and T-VIVA-19™; and diagnostic test solutions, including COVI-TRACK™, COVI-STIX™ and COVI-TRACE™. Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin ("RTX"), and ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a phase 1B trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients.  ZTlido® was approved by the FDA on February 28, 2018.For more information, visit www.sorrentotherapeutics.comForward-looking Statements This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. CONTACT: Andrew Ballou BioSig Technologies, Inc. Vice President, Investor Relations 54 Wilton Road, 2nd floor Westport, CT 06880 aballou@biosigtech.com 203-409-5444, x133

  • GlobeNewswire

    ViralClear Expands Ongoing Phase 2 Trial Size for its Oral Anti-Viral for the Treatment of COVID-19, Expands Trial Locations and Appoints Contract Manufacturing Organization to Manufacture Phase 3 Supplies of Merimepodib Oral Solution

    Westport, CT, Sept. 22, 2020 (GLOBE NEWSWIRE) -- * Size of ongoing Phase 2 trial of merimepodib in combination with remdesivir increased from 40 to 80 subjects, with focus on hospitalized patients requiring non-invasive ventilation/high flow oxygen devices * Added 2 new Principal Investigators for the ongoing Phase 2 trial expanding the total number of locations to 10 * Contract Manufacturing Organization (CMO) appointed to manufacture Phase 3 supplies of merimepodib oral solution * Merimepodib monotherapy trial to be conducted in the outpatient setting after current combination trial completesBioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”) and its majority owned subsidiary, ViralClear Pharmaceuticals, Inc.  (ViralClear), today conducted an investor update call on Viral Clear’s merimepodib drug development program for the treatment of COVID-19. The size of the ongoing randomized, double-blind, placebo-controlled Phase 2 trial of merimepodib in combination with remdesivir is being increased from 40 to 80 subjects.  When the trial was first initiated, it was thought that COVID-19 patients with National Institute of Allergy and Infectious Disease (NIAID) 8-point ordinal scores of 3 and 4 (i.e., hospitalized patients who require non-invasive ventilation and patients who require high flow oxygen devices and supplemental oxygen, respectively) would have similar outcomes in terms of their disease.  However, based on a review of blinded data from the ongoing trial, subjects with scores of 3 and 4 are showing distinct differences.  All subjects who were admitted with a score of 4 have had an uneventful course of disease and were rapidly discharged from the hospital due to improvement in clinical condition.  The subjects who were admitted with a score of 3 fared differently: one group of subjects improved and were discharged from the hospital and are doing well at long-term follow-up, while others have not improved.  Based on the above and the small numbers of subjects in each NIAID group, ViralClear decided to increase the enrollment in the current study to 80 subjects, with a focus on subjects with an NIAID score of 3 at entry.  The decision to increase the subject number in the trial was also based on advice from industry experts and discussions with government agencies and non-governmental organizations.  Once additional subjects are enrolled and further clinical data is obtained, the team will discuss with the FDA the appropriate size for a Phase 3 trial.  Two additional Principal Investigators were added to the ongoing Phase 2 trial to improve the enrollment rate, increasing the total number of locations to 10.   ViralClear has contracted with a US-based Contract Manufacturing Organization (CMO) to manufacture the registration stability batches [required for the New Drug Application (NDA) filing] of the merimepodib oral solutions (drug product) that will also serve as clinical trial supplies for the Phase 3 trial.  In July 2020, Viralclear previously announced an agreement with another US-based CMO, AMRI, to produce the registration stability batches of the merimepodib (active pharmaceutical ingredient).The merimepodib monotherapy trial to be conducted in the outpatient setting will be initiated after the completion of the current Phase 2 combination trial.  The Emergency Use Authorizations (EUAs) for remdesivir and convalescent plasma, as well as the increasing use of dexamethasone as a standard of care in hospitalized COVID-19 patients, has precluded an evaluation of merimepodib monotherapy in this setting (i.e., hospitalized patients). About BioSig Technologies BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (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.About Merimepodib and ViralClear BioSig’s Technologies, Inc (Nasdaq: BSGM) subsidiary, ViralClear Pharmaceuticals, Inc. (ViralClear), is seeking to develop a novel pharmaceutical called merimepodib to treat patients with COVID-19. Merimepodib is intended to be orally administered, and has demonstrated broad-spectrum in vitro antiviral activity, including strong activity against SARS-CoV-2 in cell cultures. Merimepodib was previously in development as a treatment for chronic hepatitis C and psoriasis by Vertex Pharmaceuticals Incorporated (Vertex), with 12 clinical trials (7 in phase 1 and 5 in phase 2) with over 400 subjects and patients and an extensive preclinical safety package was completed. A manuscript titled, “The IMPDH inhibitor merimepodib provided in combination with the adenosine analogue Remdesivir reduces SARS-CoV-2 replication to undetectable levels in vitro”, was submitted to an online peer-reviewed life sciences journal. This manuscript is authored by Natalya Bukreyeva, Rachel A. Sattler, Emily K. Mantlo, John T. Manning, Cheng Huang and Slobodan Paessler of the UTMB Galveston National Laboratory and Dr. Jerome Zeldis of ViralClear as a corresponding author. This article highlights pre-clinical data generated under contract with Galveston National Laboratory at The University of Texas Medical Branch.Forward-looking StatementsThis press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. CONTACT: Andrew Ballou BioSig Technologies, Inc. Vice President, Investor Relations 54 Wilton Road, 2nd floor Westport, CT 06880 aballou@biosigtech.com 203-409-5444, x133

  • GlobeNewswire

    Reminder: ViralClear to Host Conference Call and Webcast on September 22, 2020 to Discuss Phase 2 Human Trial of AntiViral Merimepodib Oral Solution for Treatment of COVID-19

    Westport, CT, Sept. 21, 2020 (GLOBE NEWSWIRE) -- * Randomized, Double-Blind, Placebo-Controlled, Clinical Trial of Merimepodib in Combination with Remdesivir in Hospitalized Adults with COVID-19 Who Require Non-Invasive Ventilation/High Flow Oxygen Devices or Supplemental Oxygen * Presentation to include webcastBioSig Technologies, Inc.’s (Nasdaq: BSGM) (“BioSig” or the “Company”) subsidiary, ViralClear Pharmaceuticals, Inc. (ViralClear), today announced that it will host a call and webcast to discuss its Phase 2 clinical trial.  The study is a randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of merimepodib (MMPD) in combination with remdesivir for hospitalized adult patients who have confirmed infection with SARS-CoV-2 and require non-invasive ventilation/high flow oxygen devices or supplemental oxygen (score of 3 or 4, respectively, on the NIAID 8-point ordinal scale).  The trial is being conducted at 10 investigational sites across the United States (US), with Dr. Andrew Badley, the chair of Mayo Clinic COVID-19 Research Task Force serving as the study director.    Conference Call Details: Date: Tuesday, September 22, 2020 Time: 11:00 AM Eastern Time (ET) Dial in Number: 877-407-8293/ 201-689-8349. Webcast link: https://78449.themediaframe.com/dataconf/productusers/biosig/mediaframe/40859/indexl.html A replay will be available for two weeks starting on September 22, 2020, at approximately 3:00 PM ET. To access the replay, please dial 877-660-6853 / 201-612-7415. The conference ID is 13709930.About BioSig Technologies BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (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.About Merimepodib and ViralClear BioSig’s Technologies, Inc (Nasdaq: BSGM) subsidiary, ViralClear Pharmaceuticals, Inc. (ViralClear), is seeking to develop a novel pharmaceutical called merimepodib to treat patients with COVID-19. Merimepodib is intended to be orally administered, and has demonstrated broad-spectrum in vitro antiviral activity, including strong activity against SARS-CoV-2 in cell cultures. Merimepodib was previously in development as a treatment for chronic hepatitis C and psoriasis by Vertex Pharmaceuticals Incorporated (Vertex), with 12 clinical trials (7 in phase 1 and 5 in phase 2) with over 400 subjects and patients and an extensive preclinical safety package was completed.Forward-looking Statements This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. CONTACT: Andrew Ballou BioSig Technologies, Inc. Vice President, Investor Relations 54 Wilton Road, 2nd floor Westport, CT 06880 aballou@biosigtech.com 203-409-5444, x133