AEterna Zentaris; Journal Of Clinical Oncology Publishes Phase 2 Clinical Trial Results; BioCryst Announces Positive Results From BCX4208. Print
By Staff and Wire Reports   
Wednesday, 05 October 2011 19:01
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 5, 2011.

AEterna Zentaris Inc., (NASDAQ:AEZS), announced a manuscript entitled, Randomized Placebo-Controlled Phase 2 Trial of Perifosine Plus Capecitabine as Second- or Third-Line Therapy in Patients with Metastatic Colorectal Cancer reporting Phase 2 activity of perifosine (KRX-0401) in the treatment of patients with refractory, advanced colorectal cancer (mCRC), was selected for publication in the October 3, 2011 online edition of the Journal of Clinical Oncology (JCO).

Perifosine, the Company's Akt/PI3K inhibitor, is currently being investigated in a Phase 3 trial entitled the "X-PECT" (Xeloda + Perifosine Evaluation in Colorectal cancer Treatment), which is a randomized (1:1), double-blind trial comparing the efficacy and safety of perifosine + capecitabine vs. placebo + capecitabine.

The JCO publication highlights the efficacy and safety data on the 38 mCRC patients participating in this Phase 2, randomized, multicenter study, comparing perifosine plus capecitabine (P-CAP) to placebo plus capecitabine. Based on the data, in which the combination of P-CAP demonstrated statistical significance with respect to median overall survival and median time to tumor progression, the investigators concluded that the P-CAP combination showed promising clinical activity compared to single-agent capecitabine, and that the difference in clinical outcome seen with the addition of perifosine was impressive.

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BioCryst Pharmaceuticals, Inc., (NASDAQ:BCRX), announced positive top-line results from its Phase 2b randomized, double-blind, dose-response study of BCX4208 in gout patients who had failed to reach the clinically important serum uric acid (sUA) goal of <6 mg/dL on allopurinol alone.

The study randomized 279 patients to five study arms: BCX4208 at doses of 5 mg, 10 mg, 20 mg, 40 mg and placebo, administered once-daily for 12-weeks. Allopurinol 300 mg once-daily was administered in all study arms. The primary endpoint of the study was the proportion of patients with sUA <6 mg/dL at day 85. The primary endpoint of the study was successfully achieved.

As expected, a dose-dependent effect on lymphocyte counts was observed and this effect appeared to plateau within 12 weeks of treatment. No patients from the placebo, 5 mg or 10 mg cohorts discontinued study drug due to confirmed lymphocyte or CD4+ cell counts below certain pre-specified thresholds.



Also Wednesday:



Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN), a developer of innovative medicines for serious central nervous system diseases, announced today that James S. Kuo, M.D., M.B.A., the Company's Chief Executive Officer and Chairman, will provide a brief update on its Alzheimer's program at the NYC Medtech Forum. Adeona will be one of four featured companies at the invitation-only event on Tuesday evening, October 11, 2011, at the offices of Kaye Scholer, LLP in New York City.

Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that Robert S. Langer, David H. Koch Institute Professor at the Massachusetts Institute of Technology (MIT), has been appointed to the company’s Board of Directors, and will also serve as the Chair of the Board’s Science Advisory Committee.

Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN), a developer of innovative medicines for serious central nervous system diseases, announced today that James S. Kuo, M.D., M.B.A., the Company's Chief Executive Officer and Chairman, will provide a brief update on its Alzheimer's program at the NYC Medtech Forum.

Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ), today announced that a manuscript entitled, "Randomized Placebo-Controlled Phase 2 Trial of Perifosine Plus Capecitabine as Second- or Third-Line Therapy in Patients with Metastatic Colorectal Cancer " reporting Phase 2 activity of perifosine (KRX-0401) in the treatment of patients with refractory, advanced colorectal cancer (mCRC), was selected for publication in the October 3, 2011 online edition of the Journal of Clinical Oncology (JCO).

AMERICAN SHARED HOSPITAL SERVICES (NYSE AMEX:AMS), a leading provider of turnkey technology solutions for advanced radiosurgical and radiation therapy services, announced today that the Elekta AxesseTM Radiosurgery system it supplied to Baskent University, Adana, Turkey under a contract announced in March, 2011, has treated its first patient.

BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) today announced positive top-line results from its Phase 2b randomized, double-blind, dose-response study of BCX4208 in gout patients who had failed to reach the clinically important serum uric acid (sUA) goal of <6 mg/dL on allopurinol alone. Detailed study findings will be shared at an upcoming medical meeting.

Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B), a multinational manufacturer and distributor of life science research and clinical diagnostics products, announced today that it has purchased QuantaLife, Inc. for $162 million in cash plus potential future milestone payments.

Cambridge Heart, Inc. (OTCBB: CAMH), a developer of non-invasive diagnostic tests for cardiac disease, today announced that it has concluded a review of data generated at several clinical sites including those that participated in the Company’s MTWA-CAD feasibility study.

CONMED Corporation (NASDAQ: CNMD) announced today that it expects to report third quarter 2011 financial results before the market opens on Thursday, October 27, 2011, and will also hold a conference call live over the Internet at 10:00 a.m. Eastern Time that same day.

Celgene Corporation (NASDAQ: CELG) and Agios Pharmaceuticals have agreed, ahead of schedule, to extend the initial period of exclusivity of the companies’ April 2010 collaboration agreement from three to four years.

Dynavax Technologies Corporation (NASDAQ: DVAX) and AstraZeneca (NASDAQ:AEZS) have amended their existing Collaboration Agreement to accelerate the initiation of clinical development of AZD 1419, a proprietary second-generation TLR-9 agonist for asthma.

Forest Laboratories, Inc. (NYSE: FRX) and Gedeon Richter Plc today announced preliminary top-line results from a Phase III clinical trial of cariprazine (RGH-188), an investigational antipsychotic agent, in patients with acute mania associated with bipolar I disorder.

iCAD, Inc. (Nasdaq: ICAD), an industry leading provider of advanced image analysis, workflow solutions and radiation therapies for the early identification and treatment of cancer, today announced that the American Medical Association (AMA) has assigned new Current Procedural Terminology (CPT) codes for Intraoperative Radiation Therapy (IORT).

Idera Pharmaceuticals (Nasdaq: IDRA), a biopharmaceutical company developing therapeutics targeting Toll-like Receptors (TLRs) and advancing gene-silencing oligonucleotide (GSO) technology, today announced that Jonathan Wilkin, M.D., has joined its Autoimmune Disease Scientific Advisory Board.

ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC), a biotechnology company focused on the development of novel immune-based therapies, today announced that John Yu, MD, Chairman, will deliver an oral presentation at the Annual Meeting of the Congress of Neurological Surgeons.

Lightlake Therapeutics Inc. (OTCBB: LLTP) (the “Company” or “Lightlake”), an early stage biopharmaceutical company using its expertise of opioid antagonists to develop modern addiction treatments, announced today that it will conduct Phase II trials at King’s College London on an opioid antagonist-based nasal spray treatment for Bulimia Nervosa.

Lpath, Inc. (OTCBB: LPTN), the industry leader in lipidomics-based antibody therapeutics, received official notification from the U.S. Patent and Trademark Office (USPTO) that Lpath has been issued two further patents to add to its expanding patent portfolio, which has grown now to 20 issued U.S. patents.

Luminex Corporation (NASDAQ: LMNX) announced today that it has joined forces with the National Marrow Donor Program – Be The Match to raise awareness of the need for additional donors to increase the chances of finding a match for the growing number of patients awaiting life-saving bone marrow transplants.

Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development solutions, today announced that Bryan Spielman has been named executive vice president of strategy and corporate development, reporting to CEO Tarek Sherif and President Glen de Vries.

NeoGenomics, Inc. (NASDAQ/OTCBB: NGNM) announced today that it plans to release its third quarter 2011 financial results before the market opens on Wednesday, October 19, 2011.

Sunshine Biopharma Inc. (OTCBB: SBFM), a development stage pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer, today announced that it has completed a study in which the ability of Adva-27a, its lead compound, to inhibit the activity of Topoisomerase II was measured directly.

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced that it will release its financial results for the third quarter of 2011 before the market opens on Wednesday, October 26, 2011, and will hold a conference call on the same day at 8:30 a.m. EDT.

VistaGen Therapeutics, Inc. (OTCBB: VSTA), a biotechnology company applying stem cell technology for drug rescue and cell therapy, announces a poster presentation of its research and development activities leading to validation of its human stem cell-derived "Micro-Heart" cardiotoxicity bioassay system, CardioSafe3D™, at the fourth Symposium on Cardiovascular Regenerative Medicine hosted by the National Institutes of Health's ("NIH") National Heart, Lung and Blood Institute.



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