Advances in Biotech Expanded Studies Lead to Cutting-Edge Therapeutic Treatments - Company Announces Positive Final Results in Treatment for Alzheimer's Disease

CORAL SPRINGS, Florida, March 17, 2015 /PRNewswire/ --

The latest medical projects aimed to prevent 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), TG Therapeutics, Inc. (NASDAQ: TGTX), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) and Actavis plc (NYSE: ACT)

Neurotrope, Inc. (OTCQB: NTRP) today announced secondary and exploratory endpoint results from its randomized, double-blind, placebo-controlled, single dose Phase 2a clinical trial evaluating bryostatin-1 for the treatment of Alzheimer's disease (AD). Bryostatin is a potent modulator of an enzyme called protein kinase C epsilon (PKCe). The Company is approaching the treatment of Alzheimer's 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.  Final analysis of this Phase 2a safety study, in nine Alzheimer's patients with mild dementia as measured by MMSE-2 scores, confirms the previously announced result. The study has met its primary endpoint demonstrating preliminary safety and tolerability of bryostatin. No safety signals have been identified.

Read the full NTRP press release at http://finance.yahoo.com/q/p?s=NTRP+Press+Releases

As a secondary objective, the Phase 2a safety study examined the correlation of the changes in PKCe with plasma levels of bryostatin after a single dose. Preliminary assessment of PKCe levels in peripheral monocytes demonstrated a significant increase in total PKC protein levels at the end of the bryostatin infusion consistent with target engagement.  Commenting on the study results, Charles S. Ramat, President and Chief Executive Officer of Neurotrope, Inc., said, "We are pleased to confirm the preliminary findings of the Phase 2astudy we disclosed last month, the Phase 2a met its primary endpoint, showing good safety and tolerability.  Now we can add that we achieved expected outcomes on the exploratory endpoint of PKCe activation. While we continue to recognize that this is a small trial population we are still greatly encouraged and intend to move this treatment forward to our next planned clinical trial."  An additional secondary objective of the study was the evaluation of efficacy following a single dose of bryostatin. As expected with a single dose of bryostatin, there was no measurable improvement in cognition in this mildly impaired patient population. It is important to note that in previous animal studies improvement of learning and memory was first observed following multiple doses of bryostatin. 

TG Therapeutics, Inc. (NASDAQ: TGTX) recently announced its financial results for the fourth quarter and year ended December 31, 2014 and provided recent company developments along with a business outlook for 2015. "2014 was an exciting and productive year for TG Therapeutics as we continued to aggressively move forward with the development of our lead drug candidates, TG-1101 and TGR-1202. We ended the year on a high note presenting a significant amount of data at the American Society of Hematology meeting. In addition to very encouraging data on the combination of TG-1101 and TGR-1202, we also presented data demonstrating high response rates for the combination of TG-1101 and ibrutinib, data that we believe supports our now on-going Phase 3 trial of that combination being conducted under a Special Protocol Assessment," stated Michael S. Weiss, the Company's Executive Chairman and Interim Chief Executive Officer. Read more here: http://finance.yahoo.com/news/tg-therapeutics-inc-announces-fourth-210000962.html

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) recently announced that the company and its academic collaborators, including the University of Pennsylvania (UPenn), were awarded a new five-year $16 million Integrated Preclinical/Clinical AIDS Vaccine Development Program grant from the National Institute of Allergy and Infectious Diseases (NIAID). This five-year program grant was awarded based on the clinical successes of Inovio's PENNVAX^[R] HIV vaccine program. The grant will fund research to expand PENNVAX coverage of HIV strains as well as to further enhance antibody responses generated by the vaccine.

Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX), a biopharmaceutical company focused on developing breakthrough treatments for human disease, announced that it has completed enrollment in TELESTAR, its pivotal Phase 3 clinical trial of telotristat etiprate for patients with carcinoid syndrome.  The company expects to announce top-line data from the TELESTAR trial in the third quarter of 2015. "The effects of carcinoid syndrome are severely debilitating for many people's lives, causing them to suffer from life-altering diarrhea, flushing and pain," said Lonnel Coats, Lexicon's president and chief executive officer. "Completing enrollment in this pivotal Phase 3 clinical trial marks an important step in bringing telotristat etiprate to market to help improve the lives of these individuals whose carcinoid syndrome is no longer adequately controlled by somatostatin analog treatment."

Actavis plc (NYSE: ACT) recently announced the U.S. Food and Drug Administration (FDA) has approved a lower therapeutic dose of VIIBRYD^® (vilazodone HCl) (20mg) to accompany the 40 mg daily therapeutic dose. This supplemental new drug application (sNDA) approval for VIIBRYD expands dosing options available to health care providers when using VIIBRYD to treat their adult patients with MDD. The VIIBRYD 20mg therapeutic dose is now available in pharmacies. VIIBRYD was approved in January 2011 as the first and only selective serotonin reuptake inhibitor (SSRI) and 5HT1a receptor partial agonist for the treatment of MDD in adults at a dose of 40 mg/day. The approval of the 20 mg dose fulfills a post-marketing commitment with the FDA to identify the minimum effective dose of vilazodone.

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