Dyax Reports Results of Phase 2 Trial of Ecallantide; Teva Sees Progress in Test of New Copaxone Dosage Print E-mail
By Staff and Wire Reports   
Thursday, 14 June 2012 21:21
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 14, 2012.

Dyax Corp. (NASDAQ: DYAX)
announced the decision to discontinue the Companys Phase 2 trial investigating ecallantide in the acute treatment of angiotensin converting enzyme (ACE) inhibitor-induced angioedema based upon the results of an interim analysis. This double-blind, placebo-controlled, randomized, dose-ranging study was designed to evaluate the efficacy and safety of ecallantide (10, 30, or 60 mg subcutaneous doses) compared to placebo, with a goal of enrolling 176 patients. The primary endpoint was the proportion of patients meeting a set of criteria indicating eligibility for discharge from the emergency department within 6 hours following study drug administration.

Safety was not a factor in the Companys decision to stop the clinical trial. Separately from this interim analysis of the efficacy data, an independent Data Safety Monitoring Board (DSMB) met on May 15, 2012, and reviewed blinded safety data for the first 25% of patients enrolled in the trial. The DSMB did not identify any safety concerns and did not recommend any changes to the conduct of the study.

Prior studies and literature suggested that ACE inhibitor-induced angioedema is complicated by high rates of morbidity, which drove the assumptions used to power the study. This large, multi-center, placebo-controlled trial provided an opportunity to better understand the disease, and, as such, Dyax determined that it would be prudent to conduct an interim analysis of efficacy data.

Data from the first 72 patients treated in the trial suggests a trend favoring a treatment with ecallantide over placebo; however, this trend is not statistically significant. Because the observed response rate to placebo was substantially higher than originally anticipated, the study was determined to be inadequately powered to detect a statistically significant difference between ecallantide and placebo. In addition, based upon the primary endpoint data, the enrolled population does not appear to reproduce the high morbidity described in previous medical literature.

The Company is currently assessing options regarding future investigational efforts in the acute treatment of ACE inhibitor-induced angioedema.

Todays announcement in no way diminishes our commitment to the overall angioedema space and, in particular, to patients with hereditary angioedema, said Dr. Burt Adelman, Chief Medical Officer at Dyax. "These results have no bearing on the use of Kalbitor® (ecallantide) to treat patients during an acute attack of HAE."

"Dyax will continue to actively investigate novel therapeutic approaches for angioedema disorders, including next generation therapies and testing, said Gustav Christensen, President and Chief Executive Officer of Dyax. "These results, while unanticipated, provide us with further evidence and understanding of the biology of angioedema, supporting our efforts to address these disorders and to remain at the forefront of therapeutic innovation."

The Company expects to present a detailed set of results from its ACE inhibitor-induced angioedema study at a future scientific forum.



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Teva Pharmaceutical Industries Ltd., (NYSE:TEVA)
the Jerusalem drug maker, reported progress with a new dosage for its flagship drug, Copaxone, a treatment for multiple sclerosis. A phase III study of the drug given three times a week in a dosage of 40mg met the primary endpoint by reducing the annualized relapse rate in patients by more than 34% compared with placebo, Teva said in a Thursday statement.

The drug proved safe and tolerable at the dosage when taken three times a week. Normally, Copaxone is administered daily in a 20mg dose. The one-year study assessed 1,400 patients at 155 sites worldwide. Teva said it is still analyzing data and will present the results shortly.



Also Thursday:



Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC)
, a leader in the field of regenerative medicine, announced today that the company is presenting at two upcoming conferences: the 2012 Bio International Convention and Clinical Outlooks for Regenerative Medicine meeting, both in Boston, on Tuesday, June 19.

Advaxis, Inc., (OTCBB: ADXS)
, a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that Thomas Moore, Chairman & CEO of Advaxis, will present at the Marcum MicroCap Conference on June 20th in New York City at the Roosevelt Hotel.

Allezoe Medical Holdings (OTCBB:ALZM)
today announced that it has completed the resolution of all remaining matters with Organ Transport Systems, Inc. (OTS), its former subsidiary which it disposed of in February, 2012.

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA)
today announced that its Annual Meeting of Stockholders will be webcast live on June 21, 2012 and can be accessed by visiting the investor relations section of the Company's website at http://www.ariad.com/investor.

Bion Environmental Technologies, Inc. (OTC BB/QB: BNET)
announced today that it has been notified that its U.S. Patent application 12/713,011 entitled "Method for Treating Nitrogen in Waste Streams" has been approved.

BrainStorm Cell Therapeutics Inc. (OTCBB: BCLI)
, a developer of adult stem cell therapeutics targeting Central Nervous System (CNS) neurodegenerative diseases, announced today that Brainstorm Cell Therapeutics Ltd. received the first installment of the 2012 grant from Israel’s Office of the Chief Scientist (OCS) in the amount of approximately $350,000.

Cambridge Heart, Inc. (OTCBB: CAMH)
, a developer of non-invasive diagnostic tests for cardiac disease, today announced that the prognostic value of its Microvolt T-Wave Alternans™ (MTWA) test was recently featured in Diagnostic and Interventional Cardiology (DAIC) as the Case of the Week.

CONMED Corporation (NASDAQ: CNMD)
, a medical technology company specializing in medical devices for surgical and patient monitoring markets, announced today that the Company will participate in the Wells Fargo Securities 2012 Healthcare Conference on Wednesday, June 20, 2012 at 12:40 PM Eastern time, at the InterContinental Hotel in Boston.

CytoSorbents Corporation (OTCBB: CTSO)
, a critical care-focused company using blood purification to modulate the immune system to prevent or treat organ failure caused by life-threatening illnesses, announced that Dr. Phillip Chan, Chief Executive Officer, will present at the Marcum MicroCap Conference on June 20th in New York City at the Roosevelt Hotel.

Endo Health Solutions (Nasdaq: ENDP)
, today announced the completion of the company's transition of its OPANA ER franchise to the new formulation designed to be crush resistant.  In connection with the completion of this transition, the U.S. Food and Drug Administration (FDA) has moved the old formulation of OPANA ER to the Orange Book Discontinued List.

Generex Biotechnology Corporation (OTCBB:GNBT)
announced today publication of an abstract demonstrating a more broad and robust immunological response in AE37 treated patients with prostate cancer than previously suspected.  

GenMark Diagnostics, Inc. (NASDAQ: GNMK)
, a provider of automated, multiplex molecular diagnostic testing systems, announced today that Dr. Stephen T. Worland has been appointed to GenMark's Board of Directors.

Impax Laboratories, Inc. (NASDAQ: IPXL)
today announced that the Company will present at the Wells Fargo Securities 2012 Healthcare Conference on Tuesday, June 19, at 2:30 p.m. ET.

InterMune, Inc. (NASDAQ: ITMN)
today announced that Daniel G. Welch, Chairman, Chief Executive Officer and President of InterMune, will present at the Wells Fargo Securities 2012 Healthcare Conference in Boston on Tuesday, June 19 at 3:00 p.m. EDT.

International Stem Cell Corporation (OTCBB: ISCO)
www.internationalstemcell.com announced that scientists in its wholly-owned subsidiary, Lifeline Cell Technology (LCT), have developed a technology to modify human stem cells by using engineered proteins, called "transducible transcription factors" or "TTFs." TTFs are designed to pass into stem cells and direct the stem cells to change into specific cell types that can be both therapeutically-useful and can be used as revenue-generating research products.

InVivo Therapeutics Holdings Corp. (OTC/BB: NVIV)
, a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI), today announced that Ed Wirth, MD, PhD, InVivo’s Chief Science Officer, is scheduled to present at the Clinical Outlooks for Regenerative Medicine Conference on Tuesday, June 19, 2012.

Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH)
announced today the launch of an innovative age-based test protocol that aids physicians when ordering cervical cancer and sexually transmitted disease (STD) screening tests.

Life Technologies Corporation– (NASDAQ: LIFE)
today announced that it has established a Global Instrument Center of Excellence in Singapore, to address strong customer demand around the world.

OncoSec Medical Inc. (OTCBB:ONCS)
, a company developing the advanced-stage OncoSec Medical System (OMS) ElectroOncology therapies to treat solid tumors, announced it will be presenting at a series of investor and scientific conferences in upcoming weeks.

Osiris Therapeutics, Inc. (NASDAQ: OSIR)
, announced today it has received consent from New Zealand to market its first-in-class stem cell therapy Prochymal® (remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children.

Seattle Genetics, Inc. (Nasdaq: SGEN)
today announced updated survival data from a pivotal clinical trial of single-agent ADCETRIS (brentuximab vedotin) in patients with relapsed or refractory Hodgkin lymphoma (HL) after autologous stem cell transplant (ASCT) showing that the median overall survival has not been reached after a 26.5 month median follow-up.

Tonix Pharmaceuticals Holding Corp. (OTCBB: TNXP)
(“TONIX” or the “Company”), which specializes in non-addictive treatments for chronic pain syndrome disorders, announces that Chief Executive Officer Seth Lederman, M.D. was interviewed by GLX-TV Financial News.

Verisante Technology, Inc. (TSX VENTURE:VRS) (OTCQX:VRSEF) (PINKSHEETS:VRSEF) (FRANKFURT:V3T)
(the "Company" or "Verisante"), a leader in cancer detection technology, announced today that the Company has renewed its Collaborative Research Agreement ("CRA") with the BC Cancer Agency (the "Agency") for another 13 months.

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)
today announced that Vertex will webcast its presentation at the 2012 Wells Fargo Securities Healthcare Conference on Wednesday, June 20, 2012 at 11:05 a.m. EDT.

VentriPoint Diagnostics (TSX VENTURE:VPT)(OTCQX:VPTDF)
is pleased to announce the company's President & CEO, Dr. George Adams, will appear today at 7pm (ET) on "The Next Biggest Winner" on iChannel.

A new Walgreens (NYSE: WAG) (NASDAQ: WAG) study shows that a pharmacist-led training and counseling program for patients receiving an injectable diabetes medication improved medication adherence by 24 percent.



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