Palm Beach, FL –December 10, 2019 – There are so many paths that R&D is taking in the ongoing fight against cancer. New drugs, new therapies and new techniques are developed to help researchers and practitioners across all cancer sub-markets. One such tool that is showing increased usefulness and growing revenues is Lyophilization. A recent industry report by Acumen projects that the global lyophilized drugs market size is anticipated to around USD $4,350.3 Million by 2026, and is anticipated to grow with 6.9% CAGR during the forecast time period. Rise in health awareness and extensive usage of this drugs as a quick drying method is projected to drive the growth of the global lyophilized injectable drugs market. Lyophilization transforms a drug product from a liquid to a stable solid by removing water or other solvents. Drug developers are increasingly interested in this technique as it can to extend the shelf life of both small and large molecule drugs. Active biotech and pharma companies in the markets this week include CNS Pharmaceuticals, Inc. (NASDAQ: CNSP), Precision BioSciences, Inc. (NASDAQ: DTIL), Forty Seven, Inc. (NASDAQ: FTSV), Dermira, Inc. (NASDAQ: DERM), VistaGen Therapeutics, Inc. (NASDAQ: VTGN).
The Acumen report continued: “Lyophilization is a freeze drying method which is used for water removal from the material to extend its stability and shelf life. The products that are processed under lyophilization, output products are freezed under high vacuum that is majorly used for application in pharmaceutical industries for manufacturing high quality and affordable products. The global lyophilized injectable drugs market is driven by rise in chronic health conditions, increase in elderly population suffering from cardiac diseases and advancement in drying technologies. Furthermore, lyophilization process allows safe transfer of materials to the end users. Rise in alternative method to injectable drugs can restrain the growth of lyophilized injectable drugs market. Lyophilized injectable drugs is easy to transfer as it strengthens the stability of material and offers high quality products as compared to conventional drying methods. This transformation from conventional drying method to advanced freezed drying technologies is one of the growth enablers of global lyophilized injectable drugs market over the coming years.”
CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) BREAKING NEWS: CNS Pharmaceuticals Received Positive FDA Pre-IND Guidance for Berubicin – CNS Pharmaceuticals, a biotechnology company specializing in the development of novel treatments for brain tumors, received positive feedback from the U.S. Food and Drug Administration (FDA) for its Pre-IND (Investigational New Drug) meeting proposal to use a lyophilized drug product, Berubicin, in Phase II clinical trials.
In its positive response to the Company’s previously submitted Pre-IND request, the FDA indicated that the proposal to use a lyophilized drug product in the Phase II clinical trial appears reasonable. The FDA recommended that the existing supply of Berubicin be reprocessed by batch recrystallization. Furthermore, the FDA noted that the requested dosage regimen, which will be based on the Reata Phase I trial, was reasonable. The Company plans to reprocess its existing supply of Berubicin ahead of its upcoming potential Phase II study.
“We were encouraged by the initial feedback provided by the FDA as we believe the availability of our existing supply of Berubicin for a Phase II trial represents significant costs savings and eliminates excess risk and time,” stated CEO of CNS, John M. Climaco. “We are continuing the process of preparing a new IND in accordance with the guidance we received from the FDA. We look forward to our upcoming potential Phase II trial evaluating the efficacy of Berubicin in subjects who have glioblastoma that has recurred or progressed following radiation therapy and temozolomide as we believe in Berubicin’s potential to offer oncologists the only anthracycline effective against brain cancer.” Read this and more news for CNSP at: https://financialnewsmedia.com/news-cnsp/
Other current developments in the biotech industry include:
Precision BioSciences, Inc. (NASDAQ: DTIL) recently announced updated interim clinical data from the ongoing Phase 1 trial of its lead investigational off-the-shelf (allogeneic) chimeric antigen receptor (CAR) T cell therapy candidate, PBCAR0191, which targets the well characterized cancer cell surface protein CD19. PBCAR0191 is being developed in collaboration with Servier, an international pharmaceutical company. Data will be presented by Bijal Shah, MD, Moffitt Cancer Center, at the 61st Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida, during a poster session from 6:00-8:00 p.m. ET today (Poster #4107, Hall B).
“We are very encouraged by the evidence of cell-mediated anti-tumor activity and objective tumor responses that we have observed in both NHL and B-ALL patients treated with PBCAR0191, in the context of a manageable adverse event profile,” said Chris Heery, MD, Chief Medical Officer of Precision BioSciences. “These data give us incremental confidence in our unique approach to allogeneic CAR T cell therapy, and we look forward to the potential of this therapy positively impacting the lives of more patients as the trial continues. At these still low dose levels, and using only mild lymphodepletion, it is remarkable to see anti-tumor activity in the majority of patients treated with PBCAR0191, including a durable response that lasted six months in one patient, and two complete responses. We have also seen preliminary evidence of dose dependent CAR T cell expansion and persistence, supporting our belief that cell persistence and clinical response is likely to increase as we increase dose level.”
Forty Seven, Inc. (NASDAQ: FTSV) announced preclinical proof-of-concept data for its novel all antibody conditioning regimen, comprised of FSI-174, its anti-cKIT antibody, and magrolimab, its anti-CD47 antibody. Preclinical studies in a non-human primate (NHP) model showed that the combination of FSI-174 and magrolimab significantly depleted hematopoietic stem cells (HSCs) from the bone marrow, with no dose limiting toxicities. The data will be presented in a poster session at the 61stAmerican Society of Hematology (ASH) Annual Meeting in Orlando, Florida.
“We are excited to report these preclinical data, which reflect our deep understanding of macrophage biology and our ability to build targeted antibody combinations to better facilitate phagocytosis,” said Jens-Peter Volkmer, M.D., Co-Founder and Vice President of Research and Early Development at Forty Seven. “These results demonstrate for the first time the utility of our approach in the transplant setting, and the potential of our all antibody-based conditioning regimen to successfully deplete HSCs without relying on chemotherapy or radiation. We are excited to advance FSI-174 into the clinic early next year, and to work internally and with partners to deliver a novel, non-toxic conditioning regimen for patients undergoing transplantation.”
Dermira, Inc. (NASDAQ: DERM) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for lebrikizumab, its novel, investigational treatment being evaluated for patients with moderate-to-severe atopic dermatitis. Fast Track is a designation granted by the FDA intended to facilitate the drug development process and expedite the review of therapies to treat serious conditions and fill an unmet medical need, including by demonstrating an advantage over currently available therapy. The goal of the Fast Track process is to ensure important new treatments reach patients as quickly as possible.
VistaGen Therapeutics, Inc. (NASDAQ: VTGN) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for development of the Company’s PH94B neuroactive nasal spray for on-demand treatment of social anxiety disorder (SAD).
The FDA’s Fast Track process is designed to facilitate the development and review of new treatments for serious conditions with unmet medical need, such as SAD, with the purpose of getting innovative new treatment options to patients sooner. After successful Phase 2 development, VistaGen is preparing PH94B for Phase 3 development. PH94B has potential to be the first fast-acting, non-sedating, as-needed treatment for as many as 20 million individuals in the U.S. suffering from SAD.
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