Research & Clinical Trials for Prevention of Neurodegeneration Search for Viable Therapeutic Approach for the Treatment of Severe Alzheimer's Disease

CORAL SPRINGS, Florida, April 6, 2015 /PRNewswire/ --

The latest medical research and trials aimed to identify prevention of illnesses, particularly ones related to aging and lifestyle, including Alzheimer's disease, cancer, heart disease and other serious illnesses use innovative and novel approaches to ultimately develop the licensed technology for many types of cognitive dysfunctions.  Biotech Companies in focus today: Neurotrope, Inc. (OTC: NTRP), Capnia, Inc. (NASDAQ: CAPN), Arena Pharmaceuticals, Inc., (NASDAQ: ARNA), Orexigen Therapeutics, Inc., (NASDAQ: OREX) & Inovio Pharmaceuticals, Inc., (NASDAQ: INO).

Neurotrope, Inc. (OTCQB: NTRP) today announced that Neurotrope BioScience, Inc., its wholly-owned operating subsidiary, (the "Company") has selected Worldwide Clinical Trials (WCT) to commence the pre-patient enrollment activities for the conduct of a Phase 2b trial of the Company's compound bryostatin-1 for the treatment of Alzheimer's disease. WCT is a leading worldwide clinical research organization with substantial experience in conducting a wide variety of clinical trials, including for treatment of Alzheimer's disease.

Neurotrope BioScience plans to submit its protocol to the FDA for this clinical trial in approximately 150 patients with moderately severe to severe Alzheimer's disease early in the second quarter of 2015.  The Company expects to begin enrollment for the anticipated six month study sometime during the third quarter pending the FDA's approval of the protocol, and plans to enter into a definitive agreement with WCT for services related to the study at the appropriate time, subject to available resources.

Read the full NTRP press release at http://www.financialnewsmedia.com/profiles/ntrp.html

Neurotrope BioScience has an exclusive license to develop and commercialize bryostatin, a potent modulator of an enzyme called protein kinase C epsilon (PKCe) developed by the Blanchette Rockefeller Neurosciences Institute (BRNI).  Based upon a number of BRNI pre-clinical and autopsy-validated human studies that have implicated PKCe deficits as a potential cause of Alzheimer's disease, the Company is approaching the treatment of the disease through the activation of PKCe.  In animal models of Alzheimer's disease, activation of PKCe has been shown to improve learning and memory, induce synaptogenesis or growth of new synapses and prevent neurodegeneration.  The Company has recently announced positive results of its Phase 2a safety study and is planning the larger proof of concept study mentioned above in moderately severe to severe Alzheimer's patients, which is intended to advance bryostatin for the treatment of this disease.

Additional  developments - Severe Alzheimer's Patient Responds to Bryostatin Treatment - (published March 30, 2015) Researchers at the Blanchette Rockefeller Neurosciences Institute (BRNI) and the Marshall University Joan C. Edwards School of Medicine announced their findings from a new study entitled, "PSEN1 Variant in a Family with Atypical AD" http://iospress.metapress.com/content/g8k7712lm7456552/fulltext.pdf  An Alzheimer's patient with very severe disease ("patient IV-18"), genetically confirmed to have a known variant of PSEN1, showed promising benefits during compassionate use treatment with the drug bryostatin 1.  The drug was administered by intravenous infusion once a week for the first three weeks of each month. Within two weeks of the initiation of treatment, patient IV-18 showed clinical improvements that included word vocalization, directed attentional focus, restoration of swallowing, increased responses to verbal commands, and some improvement of range of limb motion. These improvements persisted for approximately eight weeks, despite an episode of severe pneumonia that required intubation and hospitalization for four weeks.   According to BRNI, genetically confirmed Alzheimer's patients as severely advanced as patient IV-18 have not shown this level of clinical improvement previously with other treatment(s).  

"We are very encouraged by the clinical improvements observed in patient IV-18.  Nevertheless, controlled clinical trials are necessary to demonstrate safety and efficacy. BRNI believes, however, that this patient's response is supportive evidence that activation of Protein Kinase C (PKC) by potent activators such as Bryostatin, with both pre-clinical synaptogenic and anti-amyloid efficacies, could be a viable therapeutic approach for the treatment of severe Alzheimer disease", said Dr. Daniel Alkon, Scientific Director of BRNI and Chief Scientific Officer of Neurotrope BioScience, Inc. Read the full article at http://finance.yahoo.com/news/severe-alzheimers-patient-responds-bryostatin-172000986.html

In a market wrap of biotech performers from late last week:  Capnia, Inc. (NASDAQ: CAPN) had the attention of investors on Thursday (4/2/15) closing up over 6% at $7.45 on over 2 Million Shares traded by market close.  CAPN develops diagnostics and therapeutics based on its proprietary technology for precision metering of gas flow primarily in the United States. The company offers CoSense for the diagnosis of excessive hemolysis in neonates, a condition that causes long-term developmental disability due to the degradation of red blood cells. It also develops Serenz, a therapeutic product candidate that has completed phase II clinical trials for the treatment of symptoms related to allergic rhinitis.

Arena Pharmaceuticals, Inc., (NASDAQ: ARNA) closed up slightly on Thursday as well at $4.46 on just over 3.6Million shares traded by market close.  ARNA, a biopharmaceutical company, discovers, develops, and commercializes novel drugs that target G protein-coupled receptors. The company offers BELVIQ, a drug used to treat chronic weight management in adults. It is also developing a portfolio of programs in various therapeutic areas, including cardiovascular, central nervous system, and metabolic diseases. Its products under development include Ralinepag, an agonist of the prostacyclin receptor intended for the treatment of vascular diseases, including potentially pulmonary arterial hypertension that is in Phase II clinical trials.

Orexigen Therapeutics, Inc., (NASDAQ: OREX) a biopharmaceutical company, focuses on the development of pharmaceutical products in the United States. The company offers Contrave for the treatment of obesity. It has a collaboration agreement with Takeda Pharmaceutical.  OREX recently  announced that the European Commission has granted marketing authorization for Mysimba™ (naltrexone HCl / bupropion HCl prolonged release) as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of ≥ 30 kg/m2 (obese), or ≥ 27 kg/m2 to 2 (overweight) in the presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension). This authorization applies to all 28 European Union (EU) member states.

Inovio Pharmaceuticals, Inc., (NASDAQ: INO) closed up over 2% at $8.69 on over 750,000 shares traded by the market close.  INO, a clinical stage biopharmaceutical company, develops active DNA immunotherapies and vaccines in combination with proprietary electroporation delivery devices to prevent and treat cancers and infectious diseases. The company’s SynCon immunotherapy design has the ability to break the immune system’s tolerance of cancerous cells; and SynCon product design is also intended to facilitate cross-strain protection against known, as well as new unmatched strains of pathogens, such as influenza

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