– Financialnewsmedia.com News Commentary
PALM BEACH, Fla., Aug. 27, 2020 /PRNewswire/ — Across the globe, there has been an increasing prevalence on brain cancer over the past few years and the industry is expected to grow as a result. The major driving factor responsible for the growth of brain tumors is the increasing prevalence of neurological disorders, worldwide. Neurological disorders are identified as one of the most prevalent disorders, due to longer life expectancy, increasing exposure to infections and sedentary lifestyle. There are only a few brain cancer specific drugs and their high cost is acting as a restraint for brain tumor therapeutics market at present, but that should change in the future because various pharmaceutical companies are spending heavily on R&D activities (including all levels of trials) which can bring more treatment options to the market in future. Several industry reports project continued growth in the market. One such report said that the global brain tumor therapeutics market has been estimated to reach USD 2.74 billion in 2023. The market is expected to register a CAGR of 11% during the forecast period 2018 to 2023, while another report projects the global brain tumor therapeutics market is expected to gain market growth in the forecast period of 2019 to 2025, with a CAGR of 7.20% in the forecast period of 2019 to 2025 and will expected to reach $3.4 billion by 2025, from $2.25 billion in 2019. Active biotech and pharma companies in the markets this week include CNS Pharmaceuticals, Inc. (NASDAQ: CNSP), Mallinckrodt plc (NYSE: MNK), Amarin Corporation plc (NASDAQ: AMRN), Merck (NYSE: MRK), Immunic, Inc. (NASDAQ: IMUX).
The mortality rate of brain cancer in both adult and pediatric population is very high and there is also a high recurrence rate of malignant brain tumors. This necessitates the development of newer drugs in the market that demonstrate greater efficacy in treating such aggressive cancers. The median duration of patient survival of brain tumors is estimated to be between 12 and 18 months with maximal treatment. Only 2-5% of patients survive for more than three years. Despite progress in surgery, radiotherapy and chemotherapeutic strategies, effective treatments for brain cancer are limited by the lack of specific therapies for the brain and retardation of drug delivery to brain tumors due to the presence of the blood-brain barrier (BBB). Therefore, there is a substantial need for novel and effective therapeutic drugs and strategies that prolong survival and improve the quality of life for brain tumor patients.
CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) BREAKING NEWS: CNS Pharmaceuticals Announces Appointment of Dr. Patrick Wen, Director of Center for Neuro-Oncology at Dana-Farber Cancer Institute, to Science Advisory Board – CNS Pharmaceuticals, a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announces Patrick Wen, M.D., a professor of neurology at Harvard Medical School and director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute, has joined the Company’s Science Advisory Board.
“We are excited to add Dr. Wen, a neuro-oncologist with a passion for and background in investigating cures for deadly brain cancers, such as glioblastoma, to our Science Advisory Board,” commented John Climaco, CEO of CNS Pharmaceuticals. “We believe Dr. Wen’s extensive experience in the field of neuro-oncology will prove invaluable as we continue to prepare for our upcoming Berubicin clinical trials. The addition of Dr. Wen strongly complements our strategy to further drive the development of Berubicin as we look forward to initiating our Phase I pediatric and Phase II adult studies in Poland and our Phase II trial in the U.S.”
Dr. Wen is an accomplished neuro-oncologist with a proven track record of treating brain tumors and neurologic complications of cancer. He graduated from the Medical College of St. Bartholomew’s Hospital, University of London, and completed his internal medicine training at the University of London postgraduate hospitals. Subsequently, Dr. Wen completed his neurology residency in the Harvard-Longwood Neurology Training Program. He is currently a professor of neurology at Harvard Medical School and a director of the Center for Neuro-Oncology at Dana-Farber.
As previously announced, CNS Pharmaceuticals recently engaged USA-based Pharmaceutics International, Inc. (Pii) and Italian BSP Pharmaceuticals SpA (BSP) for the production of the Berubicin drug product. The Company decided to implement a dual-track drug product manufacturing strategy to mitigate COVID-19-related risks, diversify its supply chain, and provide for localized availability of Berubicin. CNS has completed synthesis of Berubicin active pharmaceutical ingredient (API) and has shipped API to both manufacturers to prepare an injectable form of Berubicin for clinical use. Read this full release and more news for CNSP at: https://www.financialnewsmedia.com/news-cnsp/
Other recent developments in the biotech industry include:
Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, recently announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Stratatech Biologics License Application (BLA) for StrataGraft®, an investigational regenerative skin tissue therapy in development for the treatment of adult patients with deep partial-thickness thermal burns. The FDA granted the application priority review and assigned a Prescription Drug User Fee Act (PDUFA) target date of February 2, 2021.
Autograft, the current standard of care for deep partial-thickness thermal burns, involves the surgical harvesting of healthy skin from an uninjured site on the patient and transplanting the skin graft to the injury, leaving the patient with more wounded areas requiring care. Each year, approximately 40,000 patients in the U.S. require hospitalization for the treatment of severe burns. The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), expressed interest in StrataGraft skin tissue as a medical countermeasure in response to large-scale burn incidents, and provided funding and technical support for the continued development of StrataGraft skin tissue.
Amarin Corporation plc (NASDAQ: AMRN) recently announced that new data that add to the growing body of knowledge on VASCEPA® (icosapent ethyl) in patients at risk for major adverse cardiovascular events will be presented at ESC Congress 2020, the annual meeting of the European Society of Cardiology (ESC), being held virtually from August 29 – September 1, 2020. These new findings will be presented in one Late-Breaking Science presentation and four rapid fire abstract and e-poster presentations from a variety of academic collaborators based on research or analyses supported by Amarin.
“Cardiovascular disease is an ever-increasing global challenge commanding both attention and action,” said Craig Granowitz, M.D., Ph.D., Amarin’s senior vice president and chief medical officer. “Often devastating, cardiovascular disease demands new research to increase our understanding of how to address residual cardiovascular risk. Several scheduled presentations at ESC provide new data on VASCEPA and its potential to address heart health in at-risk patients.”
Merck (NYSE: MRK), known as MSD outside the United States and Canada, recently announced that KEYTRUDA, Merck’s anti-PD-1 therapy, has received two new approvals from the Japan Pharmaceuticals and Medical Devices Agency (PMDA). KEYTRUDA monotherapy is now approved for the treatment of patients whose tumors are PD-L1-positive, and have radically unresectable, advanced or recurrent esophageal squamous cell carcinoma (ESCC) who have progressed after chemotherapy. Additionally, KEYTRUDA was approved for use at an additional recommended dosage of 400 mg every six weeks (Q6W) administered as an intravenous infusion over 30 minutes across all adult indications, including KEYTRUDA monotherapy and combination therapy. This new dosage option will be available in addition to the current dose of 200 mg every three weeks (Q3W). With these approvals, KEYTRUDA has 13 indications across seven tumor types plus MSI-H tumors in Japan.
Immunic, Inc. (NASDAQ: IMUX) recently announced dosing of the first healthy volunteer in the company’s phase 1 clinical program of IMU-856, an orally available, small molecule modulator that targets a yet undisclosed protein which serves as a transcriptional regulator of intestinal barrier function. Based on preclinical data, the compound appears to represent a novel and paradigm-shifting approach to the treatment of gastrointestinal diseases by potentially restoring intestinal barrier function while maintaining immunocompetency. Immunic’s Australian subsidiary, Immunic Australia Pty Ltd., received clearance from the Bellberry Human Research Ethics Committee in Australia to begin a phase 1 trial of IMU-856 under the Clinical Trial Notification (CTN) scheme of the Australian Therapeutic Goods Administration (TGA). The phase 1 clinical program includes single and multiple ascending dose parts in healthy volunteers. Subsequently, Immunic also plans to extend this program to assess biomarker, safety and drug trough levels in patients with diarrhea-predominant irritable bowel syndrome (IBS-D), ulcerative colitis (UC) and Crohn’s disease (CD).
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