PALM BEACH, Florida, September 26, 2017 /PRNewswire/ --
Moleculin Biotech, Inc. (NASDAQ: MBRX) Announces FDA Approval of Annamycin IND - Moleculin, a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some 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 the Food and Drug Administration (FDA) has advised Moleculin it may begin clinical trials of Annamycin in the treatment of relapsed or refractory Acute Myeloid Leukemia (AML). FDA's determination came after the agency completed its safety review of information and a proposed protocol submitted by Moleculin in an Investigational New Drug application (IND).
"This represents a tremendous milestone for Moleculin," commented Walter Klemp, Chairman and CEO of Moleculin. "Our primary focus has been to get Annamycin back into the clinic so we can begin optimizing the dosing of the drug as the next step in evaluating its potential to become the first 2nd line therapy suitable for the majority of relapsed or refractory AML patients. It is a thrill to now refer to Moleculin as a 'clinical stage' company." Read this and more news for Moleculin Biotech at: http://www.marketnewsupdates.com/news/mbrx.html
Dr. Don Picker, Chief Science Officer for Moleculin, added, "We are grateful for the FDA's thorough and comprehensive review of our IND, and for the manner in which they worked with us to address some key technical issues in the area of Chemistry, Manufacturing and Control."
Moleculin's Chief Medical Officer, Dr. Robert Shepard, added, "Responding to comments from the FDA, we have adopted additional patient safeguards that will be implemented while we seek to establish the 'Recommended Phase 2 Dose.' This will include reporting interim safety data to FDA before allowing US patients to progress beyond initial agreed-upon dosing limits. After seeing indications of what Annamycin may be capable of from earlier clinical trials, I made it a career goal to get the drug back into the proper clinical trials to determine its potential." The US IND going into effect also allows Moleculin to make a submission to Polish authorities necessary for the planned Annamycin clinical trial to also be conducted in Poland.
In other biotech/big pharma achievements and developments in the markets:
BioCryst Pharmaceuticals Inc. (NASDAQ: BCRX) - closed up slightly on Monday at $5.26 with over 1.3 million shares traded on the day. The company recently announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application for RAPIVAB (peramivir injection), an intravenous (i.v.) neuraminidase inhibitor, extending its availability for the treatment of acute uncomplicated influenza to pediatric patients 2 years and older who have been symptomatic for no more than two days. The pediatric approval was based on the interim analysis of an ongoing pediatric clinical study. Those results will be presented at the upcoming ID Week 2017 meeting in San Diego. "This approval represents the first new influenza antiviral for pediatric use in over 10 years," said Jon P. Stonehouse, President & Chief Executive Officer. "RAPIVAB provides another treatment option for pediatric patients with acute, uncomplicated influenza and represents another important milestone for BioCryst."
AcelRx Pharmaceuticals Inc. (NASDAQ: ACRX) closed up over 16% on Monday at $3.90 trading over 3.79 million shares bby the market close as was also up in afterhours trading. AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company, focuses on the development and commercialization of therapies for the treatment of acute pain. Its lead product candidate is DSUVIA, a 30 mcg sufentanil sublingual tablet, which is in Phase III clinical trial for the treatment of moderate-to-severe acute pain. The company's late-stage investigational product candidate is Zalviso, a pre-programmed and patient-controlled analgesia device that allows hospital patients with moderate-to-severe acute pain to self-dose with sufentanil sublingual tablets to manage their pain. Zalviso is approved in the European Union, Switzerland, Liechtenstein, Iceland, Norway and Australia, or the Territory; and is under development stage in the United States.
Marinus Pharmaceuticals Inc. (NASDAQ: MRNS) closed up over 12% on Monday at $5.50 with over 4 million shares traded on the day and also was up in afterhours trading. Marinus Pharmaceuticals reported this month that top-line data from the Phase 2 open-label study in patients with CDKL5 disorder support advancing ganaxolone into a definitive late-stage clinical trial. Oral ganaxolone, in addition to baseline treatment, showed a sizable and durable seizure-frequency reduction in the majority of patients, with some achieving an increase in the number of seizure-free days and reporting behavioral benefits. CDKL5 disorder is a severe, rare genetic epilepsy that results in early-onset, treatment-refractory seizures, pervasive neuro-developmental delay and disabling behavioral issues. There are no approved or effective available treatment options. Marinus plans to meet with regulatory agencies to obtain agreement on the clinical development plan that would be needed for approval of ganaxolone for CDKL5 disorder.
Novavax Inc. (NASDAQ: NVAX) closed up over 4% on Monday at $1.21 with over 11.4 million shares traded by the market close as was also up in afterhours trading reaching $1.23. The company recently announced the enrollment of the first participant in a Phase 1/2 clinical trial of its nanoparticle influenza vaccine candidate including its proprietary Matrix-M(TM) adjuvant (NanoFlu(TM)) in older adults. The trial is a randomized, observer-blinded, active comparator-controlled trial in approximately 330 healthy older adults. The primary objective of the trial is to assess the safety and immunogenicity of two concentrations (15 µg or 60 µg) of NanoFlu compared to a licensed influenza vaccine, Fluzone® High-Dose (Fluzone HD). "The trial is designed to identify an immune response, characterized by hemagglutination-inhibiting (HAI) and neutralizing antibodies, that is similar to or better than Fluzone HD," said Gregory Glenn, M.D., President of Research and Development. "We will evaluate immunogenicity using HAI titers, which are the industry standard and an established surrogate marker of protection. Data from this trial may provide the basis to request accelerated approval for initial licensure of our NanoFlu vaccine.
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