Vaccine for COVID-19 Health Crises "Possible" by Summer After FDA Fast-Tracks Clinical Trials

PALM BEACH, Florida, April 1, 2020 /PRNewswire/ -- The World House has called on U.S. health regulators to expedite potential therapies aimed at treating COVID-19 amid the fast-spreading coronavirus outbreak, saying it could lead to a breakthrough while a vaccine is still under development. Reuters reported that the President, speaking at a news conference, pointed to efforts on Gilead Sciences Inc's experimental antiviral drug Remdesivir and the generic antimalarial drug hydroxychloroquine, saying he had called on the U.S. Food and Drug Administration to streamline its regulatory approval process. "We have to remove every barrier," Trump said. Trials on potential coronavirus therapies are already in the works, and FDA Commissioner Stephen Hahn said his agency was working quickly to examine all possibilities. "In the short term, we're looking at drugs that are already approved for other indications," Hahn said.  "Since this outbreak first emerged, we've been working closely with our partners across the U.S government and around the globe to expedite the development and availability of critical medical products to help end this outbreak as quickly as possible… said FDA Commissioner Stephen M. Hahn, M.D… "The FDA remains deeply committed to utilizing our regulatory tools and leveraging our technical and scientific expertise to advance the availability of critical medical products to respond to this outbreak in the most expeditious, safe and effective manner possible."  Active healthcare stocks in news today include:  Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), CytoDyn Inc. (OTCQB: CYDY), Novavax, Inc. (NASDAQ: NVAX), Kiniksa Pharmaceuticals, Ltd. (NASDAQ: KNSA), Athersys, Inc. (NASDAQ: ATHX).

The McClatchy Washington Bureau added a Coronavirus pneumonia drug is possible 'by summer' after FDA fast-tracks clinical trial. They added: "Medicine for the most severe respiratory symptoms caused by the coronavirus could clear clinical trials as soon as this summer, its manufacturer said on Monday, after receiving approval to test the drug from the Food and Drug Administration.  The FDA hopes that Actemra, which is already approved for use in the United States against rheumatoid arthritis, may also be able to relieve similar inflammations experienced by severely ill coronavirus patients who have pneumonia.

Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) BREAKING NEWS - Citius Signs Exclusive Option with Novellus to License Novel Stem-Cell Therapy for Acute Respiratory Distress Syndrome (ARDS) Associated with COVID-19  - Citius Pharmaceuticals ("Citius" or the "Company"), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today signed an exclusive six-month option agreement to in-license a stem-cell therapy for acute respiratory distress syndrome (ARDS) from a subsidiary of Novellus, Inc., a preclinical-stage biotechnology company based in Cambridge, MA.

Novellus's patented process uses its exclusive non-immunogenic synthetic messenger ribonucleic acid (mRNA) molecules to create induced pluripotent stem cells (iPSCs) that, in turn, generate mesenchymal stem cells (MSCs) with superior immunomodulatory properties. MSCs have been shown to be safe in over 900 clinical trials and to be safe and effective in treating a number of inflammatory diseases, including ARDS.

"ARDS is the most common cause of respiratory failure and mortality in COVID-19 patients. Currently, there is no proven treatment for ARDS. Literature supports the use of counter-inflammatory MSCs for ARDS, and papers published in China have shown that at least seven COVID-19 patients with ARDS responded to MSC therapy. Clearly this is an avenue that shows promise and should be pursued as a potential treatment for ARDS. We believe Novellus is at the forefront of creating allogeneic, iPSC-derived MSCs. These cells have the potential to overcome the limitations of MSCs derived from adult donors, which are telomere shortened and introduce variability into the manufacturing process," said Citius Chief Executive Officer Myron Holubiak.

Novellus Chief Science Officer Matt Angel, PhD, stated, "Using our mRNA-based cell-reprogramming technology, Novellus can provide a near-unlimited supply of MSCs for treating patients with ARDS, including those critically ill from COVID-19. These will be allogeneic ('off-the-shelf') cells that in vitro have demonstrated much greater expansion potential and much higher immunomodulatory protein expression than donor-derived MSCs. We are excited to employ our technology to such an urgent medical crisis and believe that our MSCs represent an ideal source of cells to be used in this extremely important development effort."

Holubiak added, "No effective pharmacotherapy for ARDS exists, and ARDS-related morbidity and mortality are high. MSCs have been studied in the treatment of lung injury, and we aim to build upon this work with Novellus's iPSC-derived MSCs to improve the immunomodulatory response in humans. We have assembled a team of experts who are dedicated to advancing this project to an Investigational New Drug (IND) application as quickly as possible."     

In other healthcare news of note:

Kiniksa Pharmaceuticals, Ltd. (NASDAQ: KNSA) a biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients with significant unmet medical need, recently announced early evidence of treatment response with mavrilimumab, an investigational fully-human monoclonal antibody that targets granulocyte macrophage colony stimulating factor receptor alpha (GM-CSFRα), in a treatment protocol in patients with severe coronavirus 2019 (COVID-19) pneumonia and hyperinflammation. The treatment protocol was conducted by Professor Lorenzo Dagna, MD, FACP, Head, Unit of Immunology, Rheumatology, Allergy and Rare Diseases IRCCS San Raffaele Scientific Institute and Vita-Salute San Raffaele University in Milan, Italy within a COVID-19 Program directed by Professor Alberto Zangrillo, Head of Department of Anesthesia and Intensive Care of the Scientific Institute San Raffaele Hospital and Professor in Anesthesiology and Intensive Care, Università Vita-Salute San Raffaele.

The treatment protocol with the investigational drug mavrilimumab was a prospective, interventional, single-active-arm, single-center pilot experience. Patients suffering from severe pulmonary involvement of COVID-19, acute respiratory distress, fever, and clinical and biological markers of systemic hyperinflammation status were treated with a single intravenous dose of mavrilimumab. The objective was to reduce incidence of progression of acute respiratory failure, the need of mechanical ventilation, and the transfer to the intensive care unit.

CytoDyn Inc. (OTCQB: CYDY) recently announced that the U.S. Food and Drug Administration (FDA) just provided clearance for initiation of a Phase 2 trial with CytoDyn's leronlimab to treat COVID-19 patients with mild to moderate indications. The Company's investigational new drug, leronlimab, has been administered to 10 severely ill patients with COVID-19 at a leading medical center in the New York City area under an emergency IND recently granted by the FDA. The treatment with leronlimab is intended to serve as a therapy for patients who experience mild-to-moderate respiratory complications as a result of contracting SARS-CoV-2 causing the Coronavirus Disease 2019 (COVID-19).

The Phase 2 clinical trial is a randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of leronlimab in patients with mild to moderate documented COVID-19 illness and calls for 75 planned patients in up to 10 centers in the United States. Patients enrolled in the trial are expected to have a treatment window of approximately 6 weeks.

Novavax, Inc. (NASDAQ: NVAX) recently announced positive top-line results of its pivotal Phase 3 clinical trial of NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate with its proprietary Matrix-M™ adjuvant, in adults aged 65 and older. Using the Food and Drug Administration's (FDA) criteria for accelerated approval of seasonal influenza vaccines, the trial evaluated the immunogenicity and safety of NanoFlu compared to Fluzone^® Quadrivalent, a U.S.-licensed quadrivalent influenza vaccine.

"With these data, we now have a clear path forward to licensure with our differentiated recombinant influenza vaccine," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "These strong Phase 3 results align with and validate our previous clinical trials, in which NanoFlu showed higher HAI antibody responses than the leading flu vaccine for older adults. We expect that both Fast Track designation and the accelerated approval pathway from the FDA will help Novavax bring NanoFlu to market as quickly as possible to address the serious public health threat of influenza."

Athersys, Inc. (NASDAQ: ATHX) recently announced the addition of Ms. Maia Hansen, an experienced leader in operations and supply chain management, to the Athersys leadership team. Ms. Hansen has been appointed Senior Vice President, Operations and Supply Chain to help establish and manage a sustainable supply chain built to enable reliable, cost-effective and best in class commercial manufacturing and product distribution capabilities to support commercial success. Ms. Hansen will have overall responsibility for supply chain strategy, related operations and capability building. She will work closely with Mr. Greg Liposky, Senior Vice President and Head of Manufacturing, and the rest of the executive team to establish a premier product supply organization and capabilities oriented to sustainable, large scale commercialization.

Ms. Hansen has extensive operations and supply chain experience in the pharmaceutical, medical device and consumer health sectors.  We are very excited to have Maia join the leadership team at Athersys. As we've described previously, we are committed to building a world-class organization that is well-positioned to deliver on the promise of our innovative regenerative medicine technology, and to helping advance the boundaries of medicine in areas where there is a substantial unmet medical need. Maia brings tremendous experience and capabilities, and she will play an important role as we move forward," commented Dr. Gil Van Bokkelen, Chairman and CEO at Athersys.

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