PALM BEACH, Florida, November 15, 2018 /PRNewswire/ --
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Pancreaticcancer is one of the nation's deadliest cancers with a five-year survival rate of just under 10 percent. It's a disease that has been documented to kill more people than breast cancer in the U.S. alone and it is projected to become the second leading
Moleculin Biotech, Inc., (NASDAQ:MBRX) BREAKING NEWS: Moleculin Biotech, a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it has filed a request with the US Food and Drug Administration (FDA) for a Pre-Investigational New Drug (IND) Meeting to seek FDA's guidance and concurrence that the WP1732 development plan will meet requirements for an Initial IND filing and initiation of a proposed Phase 1 clinical trial.
"Independent animal model testing has now confirmed high uptake and retention of WP1732 in the pancreas," commented Walter Klemp, Moleculin's Chairman and CEO. "Taken together with the previous observations of consistent activity against pancreatic cancer in in vitro and in vivo tumor models, this could make WP1732 ideally suited as a new therapy for treating pancreatic cancer. Our request for a Pre-IND Meeting with the FDA represents another important milestone in our effort to begin clinical trials with this promising new drug candidate." Read this and more news for MBRX at: https://www.financialnewsmedia.com/news-mbrx/ Other recent developments in the biotech industry include: Amarin Corporation plc (NASDAQ:AMRN) recently announced primary results from the Vascepa® (icosapent ethyl) cardiovascular (CV) outcomes trial, REDUCE-IT™, following presentation of the late-breaking clinical trial results at the 2018 Scientific Sessions of the American Heart Association (AHA) in Chicago, Illinois. REDUCE-IT primary results confirmed 25% relative risk reduction (RRR) for the topline primary endpoint result with multiple robust demonstrations of efficacy, including 20% reduction in cardiovascular death. Cardiovascular benefits appeared not to be influenced significantly by triglyceride (TG) levels at baseline (135 mg/dL to 499 mg/dL baseline range) or as achieved at one year, suggesting mechanisms at work with use of Vascepa that are independent of triglyceride reduction. Results were robust across multiple subgroups, including in patients with and without diabetes at baseline.
Clovis Oncology Inc. (NASDAQ:CLVS) recently announced initial data from its ongoing Phase 2 TRITON2 clinical trial of Rubraca at the ESMO 2018 Congress (European Society for Medical Oncology). The data show a 44% confirmed objective response rate (ORR) by investigator assessment in 25 RECIST* /PCWG3** response-evaluable patients with a BRCA1/2 alteration. The median duration of response in these patients has not yet been reached. In addition, a 51% confirmed prostate specific antigen (PSA) response rate was observed in 45 PSA response-evaluable patients with a BRCA1/2 alteration. The TRITON2 results were the basis for Breakthrough Therapy designation for Rubraca as a monotherapy treatment of adult patients with BRCA1/2 mutated mCRPC who have received at least one prior androgen receptor (AR)-directed therapy and taxane-based chemotherapy, which was granted on October 2, 2018 by the U.S. Food and Drug Administration (FDA). These data will be highlighted in a poster authored by Dr. Wassim Abida, Medical Oncologist, Memorial Sloan Kettering Cancer Center, and principal investigator for the TRITON2 study.
Eli Lilly and Company (NYSE:LLY) on Wednesday announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lasmiditan for the acute treatment of migraine with or without aura in adults. Lasmiditan is an investigational, oral, centrally-penetrant, selective serotonin 5-HT1F agonist that is structurally and mechanistically distinct from other approved migraine therapies and lacks vasoconstrictive activity. It is the first and only molecule in the "-ditan" class under evaluation for the acute treatment of migraine in adults. If approved, it could represent the first significant innovation for the acute treatment of migraine in more than two decades. Lilly also plans to submit an sBLA to the FDA for Emgality for the preventive treatment of episodic cluster headache in adults by the end of the year. The FDA has granted Breakthrough Therapy Designation to Emgality for episodic cluster headache.
Novartis AG (NYSE:NVS) recently announced it will present new research that may transform the way serious blood diseases and a certain type of breast cancer are treated at the upcoming 60th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego, December 1-4 and the 41st Annual San Antonio Breast Cancer Symposium (SABCS), December 4-8. Nearly 150 abstracts will be presented across both congresses, underscoring the strength of the Novartis pipeline and portfolio in hematology and oncology. "Novartis Oncology has a purpose-driven legacy built on an unwavering commitment to help patients live better and longer lives," said Liz Barrett, CEO, Novartis Oncology. "The breadth and depth of our data at these scientific forums demonstrates how we are acting on our vision to reimagine cancer in a meaningful way for patients by relentlessly pursuing scientific advancements and exploring novel combination treatment options to help those living with hard-to-treat diseases."
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