Adamas Announces Additional Findings From Its Phase 2/3 Trial of ADS-5102 for the Treatment of Levodopa-induced Dyskinesia (LID) Associated with Parkinson's Disease

Analysis of Patient Diaries Indicates Treatment with ADS-5102 Increases ON Time Without Troublesome LID Throughout Day

EMERYVILLE, Calif., June 15, 2015  -- Adamas Pharmaceuticals, Inc. (ADMS) today announced additional findings from its Phase 2/3 study (EASED) evaluating ADS-5102 for the treatment of levodopa-induced dyskinesia (LID), a movement disorder associated with the treatment of Parkinson's disease. Patient diary data were analyzed to characterize the time course of troublesome LID and other Parkinson's disease states during waking hours, synchronized to the patients' wake-up times as well as to elucidate the impact of treatment with ADS-5102. These data showed that troublesome LID was reported throughout the day. After eight weeks of treatment, the majority of ADS-5102-treated patients reported an increase in the quality of ON time by increasing ON time without troublesome LID throughout the morning, afternoon and evening. In contrast, placebo-treated patients reported little change in their dyskinesia. These results (Abstract # 329) are being presented at the 19th International Congress of Parkinson's Disease and Movement Disorders in San Diego, California.

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Aerie Pharmaceuticals Receives Positive Feedback from FDA

-Rocket 2 Primary Endpoint Range Modified upon FDA Agreement- Conference Call and Webcast Today, June 15, at 5:00 p.m. ET

IRVINE, Calif. -- Aerie Pharmaceuticals, Inc. (AERI) (the “Company”), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye, today reported that the U.S. Food and Drug Administration (FDA) has agreed in written and verbal communications that Aerie may change the primary endpoint range of its second Phase 3 registration trial of RhopressaTM, named Rocket 2. With this agreement, the Company is changing the primary endpoint range to include patients with baseline intraocular pressures (IOPs) ranging from above 20 mmHg (millimeters of mercury) to below 25 mmHg. The former range for the primary endpoint of above 20 mmHg to below 27 mmHg will now represent a secondary endpoint range for Rocket 2.

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BioLife Solutions CryoStor® Cited in New Journal Article on Results of Phase I/II Clinical Trial of Dendritic Cell Immunotherapy for Prostate Cancer

Clinical Grade CryoStor® Incorporated as Combined Freeze Media and Vehicle Solution for Administering Cells to Patients

BOTHELL, Wash., June 15, 2015 -- BioLife Solutions, Inc. (BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media and a related cloud hosted biologistics cold chain management app for smart shippers ("BioLife" or the "Company"), today announced that a new clinical article citing the use of the Company's CryoStor cryopreservation freeze media with a dendritic cell based vaccine was published in the journal Oncotarget. 

The article can be viewed here: Phase I/II clinical trial of dendritic-cell based immunotherapy (DCVAC/PCa) combined with chemotherapy in patients with metastatic, castration-resistant prostate cancer.

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BioBlast Announces the Start of a Phase 3 Study for Cabaletta in Oculopharyngeal Muscular Dystrophy (OPMD)

New Pivotal Study Reflects Positive Signals Reported From the Current HOPEMD Study, Which Will Be Closed Out at 25 Patients

TEL AVIV, Israel, June 15, 2015 -- BioBlast Pharma Ltd. (ORPN), a clinical-stage orphan disease-focused biotechnology company, announced today the start of a Phase 3 pivotal study in the USA and Canada for Cabaletta (trehalose) in Oculopharyngeal Muscular Dystrophy (OPMD).

 

Colin Foster, BioBlast's President and CEO said, "We see positive signals in a consequential number of the 25 treated patients currently enrolled in our open label HOPEMD study, with respect to various muscle and other performance tests. These positive signals lead us to believe that the clinical study duration required to demonstrate efficacy may be considerably shorter than we initially predicted.

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RedHill Biopharma to Host Conference Call Today to Review Positive Phase III Top-Line Results With RHB-105 for H. Pylori Infection

TEL-AVIV, Israel, June 15, 2015  -- RedHill Biopharma Ltd. (RDHL) (RDHL) ("RedHill" or the "Company"), an Israeli biopharmaceutical company focused on late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today announced positive top-line results from its Phase III study with RHB-105 for the treatment of Helicobacter pylori (H. pylori) bacterial infection. Top-line results from the study demonstrated 89.4% efficacy in eradicating H. pylori infection with RHB-105.

The ERADICATE Hp first Phase III study successfully met its primary endpoint of superiority over historical standard of care efficacy levels of 70%, with high statistical significance (p <0.001). No serious adverse events, new or unexpected safety issues were identified in the study.

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