PALM BEACH, Florida, October 25, 2018 /PRNewswire/ --
Financialnewsmedia.com News Commentary
Cancerhas a major impact on the health and well being of individuals across the globe. Cancer is identified as one of the leading causes of death worldwide. In 2017, approximately 0.5% of the world's population was suffering from cancer. According to a senior
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 that investigators at Emory University will present animal model data supporting the potential of WP1066 to treat pediatric brain tumors at the upcoming Society for Neuro-Oncology Annual Scientific Meeting. "A number of independent institutions have published results supporting the potential for WP1066 to kill tumors in a range of animal models," commented Walter Klemp, Moleculin's Chairman and CEO. "Having this corroborated yet again by data presented from Emory University just adds to the enthusiasm for testing WP1066 in humans. What makes this particularly important is that our drug showed activity against the most common form of childhood brain tumor, medulloblastoma, for which there is a desperate need for more effective treatments."
Mr. Klemp continued, "We are also proud of the fact that two different Moleculin technologies, WP1066 and WP1122 (see Moleculin press release dated October 10, 2018), are being presented at this prestigious conference on brain tumors. We believe this is a strong indicator of the breadth and significance of our development pipeline." Read this and more news for MBRX at: http://www.financialnewsmedia.com/news-mbrx/ Other recent developments in the biotech industry include:
Clementia Pharmaceuticals Inc. (NASDAQ:CMTA) recently announced it plans to submit a New Drug Application (NDA) for palovarotene to the U.S. Food and Drug Administration (FDA) in the second half of 2019. Based on recent interactions between Clementia and the FDA, including a Type B meeting held earlier today as part of palovarotene's Breakthrough Therapy Designation, the FDA has agreed that available data would support filing of an NDA for palovarotene for the prevention of heterotopic ossification (HO) associated with flare up symptoms in patients with fibrodysplasia ossificans progressiva (FOP). The FDA based its assessment on the efficacy and safety data available from the completed Phase 2 clinical program, which showed a statistically significant reduction in mean new HO volume, or bone volume, associated with flare-ups of FOP at 12 weeks as compared to placebo or untreated flare-ups. The data provided to the FDA included the results from Clementia's Phase 2 studies, which were recently presented at ASBMR 2018. In these studies, 92 palovarotene-treated flare-ups in 62 patients across three different dosing regimens were evaluated compared to 46 placebo or untreated flare-ups in 41 patients from the Company's natural history study. Patients treated with palovarotene at the time of a flare-up demonstrated a greater than 70 percent reduction in mean new HO volume at 12 weeks compared to the untreated group.
SCYNEXIS Inc. (NASDAQ:SCYX) recently announced the successful completion of an End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA) for its lead product candidate, ibrexafungerp (formerly SCY-078), for patients with vulvovaginal candidiasis (VVC). The FDA has agreed with the Company's proposed overall design of the Phase 3 registration program to support approval of oral ibrexafungerp for the treatment of VVC and prevention of recurrent VVC. SCYNEXIS expects to initiate the program in the fourth quarter of 2018. Ibrexafungerp, the first representative of a novel oral and intravenous (IV) triterpenoid antifungal family, is in clinical development for the treatment of multiple serious fungal infections, including VVC, invasive candidiasis (IC), invasive aspergillosis (IA) and refractory invasive fungal infections. If approved, Ibrexafungerp would be the only oral alternative to azoles for the treatment of VVC and prevention of recurrent VVC.nounces-fda-agreement-company-130000875.html
AcelRX Pharmaceuticals Inc. (NASDAQ:ACRX) last week announced it stands by the safety, efficacy and medical need for its investigational therapy, DSUVIA™. Developed in collaboration with the Department of Defense, DSUVIA potentially represents an important non-invasive, rapidly acting alternative to IV opioids, the current standard of care for acute pain management in medically supervised settings. We appreciate the thoughtful and thorough discussion among the 13 committee members, as well as the forum for public commentary. The Committee voted 10-3 in favor of recommending the approval of DSUVIA for the management of moderate-to-severe acute pain in medically supervised settings for adult patients. AcelRx is committed to continued collaboration with the FDA on the new drug application for DSUVIA. About DSUVIA (sufentanil sublingual tablet), 30 mcg DSUVIA (sufentanil sublingual tablet, 30 microgram), known as DZUVEO™ outside the United States, has a proposed indication for the management of moderate-to-severe acute pain in medically supervised settings, in adult patients and was designed to eliminate dosing errors associated with IV administration via its non-invasive single-dose applicator (SDA) administered by health care professionals. Sufentanil is an opioid analgesic currently marketed for intravenous (IV) and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration.
Therapix Biosciences Ltd. (NASDAQ:TRPX) recently announced it signed a binding letter of intent (the "LOI") with FSD Pharma Inc., under which FSD will acquire Therapix, effective October 22, 2018 (the "Transaction"). The Transaction focuses on Therapix proprietary IP and related technology, and assets pertaining to all clinical stage pharmaceutical assets applications, excluding certain pain assets, such as the US based pain clinics. The Transaction combines two highly-complementary businesses and creates a medical cannabis industry leader focused on the research and development of advanced and innovative cannabinoid treatments. The all-stock Transaction values Therapix Biosciences at approximately $48 million (USD) and the shareholders of Therapix will receive FSD stock upon closing of the Transaction. The terms of the LOI will be superseded by a definitive agreement, which the parties intend to execute within 30 days.
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