Zafgen Presents New Data from the Phase 3 bestPWS Study Evaluating Beloranib in Prader-Willi Syndrome at ENDO 2016

--bestPWS Study is the first Phase 3 pivotal trial to show significant weight-loss and improvement in hyperphagia-related behaviors in PWS patients--
--Beloranib was associated with improvement in total cholesterol, LDL cholesterol and other markers of cardiometabolic risk --
--Beloranib demonstrated a statistically significant reduction in fat mass at both 1.8 mg and 2.4 mg dose levels--
 
BOSTON, April 03, 2016  -- Zafgen Inc. (ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today announced new data from the bestPWS ZAF-311 study, a pivotal, double-blind, placebo-controlled Phase 3 trial evaluating the safety and efficacy of beloranib, a MetAP2 inhibitor, in patients with Prader-Willi syndrome (PWS) during the six-month randomized treatment period. Data presented today during ENDO 2016, the Endocrine Society’s 98th Annual Meeting & Expo, showed that beloranib was associated with improvement in total cholesterol, LDL cholesterol and other cardiometabolic risk factors, and a reduction in fat mass when compared to placebo.
Read more: Zafgen Inc ( ZFGN )

Akari Therapeutics Announces Positive Preliminary Results from First PNH Patient Treated With Coversin

NEW YORK and LONDON, March 31, 2016 -- Akari Therapeutics (AKTX), an emerging growth, development-stage biopharmaceutical company, announced today preliminary results from the first paroxysmal nocturnal hemoglobinuria (PNH) patient treated with subcutaneously administered Coversin. The patient, diagnosed with PNH and resistant to eculizumab due to a polymorphism was started on Coversin under a clinical trial protocol approved by a EU national regulatory authority for treating PNH patients with eculizumab resistance. On Coversin therapy, administered subcutaneously, the patient demonstrated clinical and symptomatic improvement, complement inhibition (as measured by the CH50 assay) and a marked reduction of LDH (a marker of blood hemolysis). The patient will continue self-injection as per the protocol. Coversin is a second-generation complement inhibitor that acts on complement component-C5, preventing release of C5a and formation of C5b-9 (also known as the membrane attack complex or MAC). C5 inhibition is growing in importance in a range of rare autoimmune diseases related to dysregulation of the complement component of the immune system, including paroxysmal nocturnal hemoglobinuria (PNH), atypical Hemolytic Uremic Syndrome (aHUS), and Guillain Barré syndrome (GBS).
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Verastem Announces Presentation of Scientific Data Supporting FAK Inhibition in Combination with Immunotherapy at the Keystone Symposium on Cancer Pathophysiology

BOSTON-- Verastem, Inc. (VSTM), focused on discovering and developing drugs to treat cancer, today announced the oral presentation of preclinical data by the Company’s scientific collaborator David G. DeNardo, PhD, Assistant Professor of Medicine, Division of Oncology, Department of Immunology, Washington University School of Medicine in St. Louis, at the Keystone Symposium on Cancer Pathophysiology being held March 28 – April 1, 2016 in Breckenridge, CO.
 
“To date, single-agent immunotherapy has achieved limited clinical benefit for patients suffering from pancreatic cancer,” said Dr. DeNardo. “This is thought to be due to abundance of tumor-associated immune-suppressive cells in pancreatic tumors along with the dense stroma that prevents T cell entry. Our data show that Verastem’s FAK inhibitor dramatically reduced tumor stroma and reduced numbers of immunosuppressive cells in pancreatic cancer models. Further, when the FAK inhibitor was combined with immune checkpoint antibodies, the tumors became highly responsive leading to a near tripling of survival times relative to checkpoint inhibitors alone.”
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MediciNova Announces Publication of Positive Findings from Completed Phase 1b Clinical Trial of MN-166 (ibudilast) in Methamphetamine Dependence

LA JOLLA, Calif., March 30, 2016  -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that the medical journal Drug and Alcohol Dependence has published a new article regarding positive findings from a completed Phase 1b clinical trial of MN-166 (ibudilast) in methamphetamine dependence.  The article, which was written by Matthew J. Worley, Keith G. Heinzerling, and colleagues at the University of California, Los Angeles (UCLA), reports that MN-166 (ibudilast) was shown to significantly reduce the subjective effects of methamphetamine in subjects diagnosed with methamphetamine dependence.
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Genital Herpes Immunotherapy GEN-003 Shows Sustained Reduction of Viral Shedding Rate, Durable Impact on Clinical Disease 12 Months Post-Dosing

- Consistent efficacy across potential Phase 3 clinical trial endpoints -
- Once-yearly or less frequent maintenance dosing expected -
- Company to host conference call at 9 a.m. ET today -
 
CAMBRIDGE, Mass., March 31, 2016 -- Genocea Biosciences, Inc. (GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today announced positive 12 month efficacy data from its Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes. GEN-003 demonstrated sustained and statistically significant reductions compared to baseline in the rate of viral shedding 12 months after dosing across multiple dose groups as well as sustained efficacy at multiple dose levels across secondary endpoints measuring the impact on clinical disease. GEN-003 was safe and well tolerated by patients, with no serious adverse events related to the vaccine in the trial.
Read more: Genocea Biosciences Inc ( GNCA )