Merck H.I.V. Trial Vaccine Stopped; J&J's Xarelto Cited for Missing Data Print E-mail
By Staff and Wire Reports   
Monday, 21 May 2012 18:55
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 21, 2012.

A follow-up study on a Merck (NYSE:MRK) AIDS vaccine trial that had to be stopped early has confirmed the worst fears of researchers: The vaccine made it more likely, not less, that some men would become infected with H.I.V.

Men who were not circumcised and who had previously caught common colds caused by the same virus used to make the vaccine were two to four times as likely as other men to become infected if they got the vaccine, the study concluded.

The new study shed no new light on how that happened. “I really wish I could tell you why, but I can’t,” said Dr. Ann Duerr, a vaccine specialist at the Fred Hutchinson Cancer Research Center in Seattle, who led the data analysis for the new study.

The trial of the Merck vaccine, which involved 3,000 volunteers in nine countries, began in 2004 and was abruptly halted in late 2007 when it became clear that it was not protecting anyone and suspicions arose that it was making some men more susceptible.

It was a frustrating failure and had repercussions across the AIDS vaccine field. Nine months later, government investigators canceled a trial of a similar vaccine because they were not sure why Merck’s had failed.

The search for an AIDS vaccine has proceeded slowly and cautiously since then. The only success in the field — and there are many skeptics who doubt even the weak success that was proclaimed — came in 2009. A vaccine called RV 144 that was tested on 16,000 Thai volunteers seemed to lower, at least temporarily, a man’s chances of getting infected with H.I.V. by about 31 percent. But why that one worked, albeit badly, has remained a mystery.

The new study, published online this month in The Journal of Infectious Disease, followed 1,836 men from the Merck trial through the end of 2009. (More than a third of those who got the vaccine were women, but so few of them became infected that data about them was ignored.)

Of those men, 172 ultimately became infected. Uncircumcised men were more likely to get infected, as were men who began the trial with high levels of antibodies to Type 5 adenovirus -- one of hundreds of viruses that can cause sniffles and headache -- before they got the vaccine.

But that increased vulnerability seemed to fade after 18 months.


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U.S. drug reviewers said Johnson & Johnson's (NYSE:JNJ) blood thinner Xarelto appeared to reduce the risk of new heart attacks and strokes in people with heart problems, but missing data raised doubts about whether the drug actually worked.

The U.S. FDA staff reviewed the drug ahead of an advisory panel of outside experts, which will vote on whether to recommend the drug on Wednesday.

The FDA usually follows panel recommendations, although it is not required to, and is due to make a final decision on Xarelto by the end of June.



Also Monday:



Atlas Therapeutics Corporation (OTCBB: ATTH) (OTCBB: MYOS)
, a company focused on the discovery, development and commercialization of muscle health and performance therapeutic products, today announced it has changed its name to MYOS Corporation and its ticker symbol to "MYOS".

BIOLASE, Inc. (NASDAQ: BLTI)
, the World's leading dental laser manufacturer and distributor, today announced that its ticker symbol will change from "BLTI" to "BIOL" on May 29, 2012.

Biostem U.S., Corporation, (OTCQB: HAIR) (PINKSHEETS: HAIR)
(Biostem, the Company), a fully reporting public company in the stem cell regenerative medicine sciences sector, today announced that Jeanne Ann Lumadue, MD, PhD, MBA, has been appointed to its Scientific and Medical Board of Advisors (SAMBA).

BioTime, Inc. (NYSE MKT: BTX)
and its subsidiary LifeMap Sciences, Inc. today announced that they have completed the acquisition of XenneX, Inc. through a merger of XenneX into LifeMap Sciences.

Cellceutix Corporation (OTCBB: CTIX)
, a biopharmaceutical company developing a novel drug to treat cancers and cancers which have proven resistant to today's cancer therapies (drug-resistant cancers), is pleased to announce that its amended Investigational New Drug ("IND") application for Kevetrin™ has been submitted to the U.S. Food and Drug Administration ("FDA") today.

Cord Blood America, Inc. (OTC Bulletin Board: CBAI)
, the umbilical cord blood stem cell preservation company focused on bringing the life saving potential of stem cells to families nationwide and internationally, today announced that revenues for the first quarter of 2012 increased by 6.7%  to $1.55 million compared to $1.45 in the same period last year.

Dendreon Corporation (NASDAQ: DNDN)
today announced the following PROVENGE® (sipuleucel-T) data will be presented at the American Urological Association (AUA) Annual Meeting taking place May 19 – 23, 2012 in Atlanta, Georgia.

Dr. Reddy’s Laboratories (NYSE: RDY)
announced today that it has launched over-the-counter (OTC) Lansoprazole delayed-release capsules in the U.S. market on May 18, 2012, following Dr. Reddy’s ANDA approval by the United States Food & Drug Administration (USFDA).

Emergent BioSolutions Inc. (NYSE: EBS)
today announced that its Board of Directors has authorized the repurchase of up to $35 million of the company’s common stock from time to time on the open market or in privately negotiated transactions.

Genesis Biopharma, Inc. (OTCBB: GNBP)
, a biotechnology company developing targeted cancer immunotherapies, announces the posting of the following Letter to Shareholders to the Investors section of the Company's website at www.genesis-biopharma.com.

GenVec, Inc. (NASDAQ: GNVC)
today announced that effective May 23, 2012 Cynthia Collins has been appointed as President and Chief Executive Officer.

Home Health International, Inc. (PINKSHEETS: HHII)
announced today that the Company has completed the acquisition of Faya's Medical Equipment, Inc., a licensed Florida-based durable medical equipment (DME) company.

Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX)
today announced that an abstract highlighting the dose related increases in iron storage parameters as observed in prior clinical trials of Zerenex™ (ferric citrate), has been accepted for poster presentation at the upcoming 49th ERA-EDTA (European Renal Association – European Dialysis and Transplant Association) Congress, taking place May 24-27, 2012, in Paris, France.

Merck (NYSE: MRK)
, known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved a labeling update for ISENTRESS® (raltegravir) Film-coated Tablets to include 156-week data from the STARTMRK study with ISENTRESS in combination therapy compared to efavirenz in combination therapy in previously untreated (treatment-naïve) adult HIV-1-infected patients.

Neuralstem, Inc. (NYSE MKT: CUR)
announced that Richard Garr, CEO and President, will present at the World Stem Cells & Regenerative Medicine Congress in London (http://www.terrapinn.com/2012/stemcells/index.stm) on Tuesday, May 22nd at 12:30 PM.

Opexa Therapeutics, Inc. (NASDAQ:OPXA)
, a biotechnology company developing a novel T-cell therapy for multiple sclerosis (MS), announced today that the Company is rebranding its leading MS therapy with the new name TcelnaTM.

Oramed Pharmaceuticals Inc. (OTCBB: ORMP.OB)
, a developer of oral delivery systems, announced today that it was chosen to present at the 11th National Life Science & Technology Week ILSI-BIOMED Conference taking place in Israel on May 21-23, 2012.

Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX)
today announced that it has been selected for inclusion in the NASDAQ Biotechnology Index® (NASDAQ: NBI) effective today.

Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM) today announced positive top-line results from its randomized, double-blind, placebo-controlled Phase IIb trial evaluating two dose levels of bavituximab plus docetaxel versus docetaxel plus placebo (control arm) in patients with second-line non-small cell lung cancer (NSCLC).

Rockwell Medical (NASDAQ: RMTI)
, a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis, announced today that it has received notice from the European Patent Office that it has obtained patent issuance on its proprietary GMP formulation for Soluble Ferric Pyrophosphate (SFP), the Company's lead investigational drug that provides iron replacement to hemodialysis patients with CKD.

Sangamo BioSciences, Inc. (Nasdaq: SGMO)
announced today that data from clinical, preclinical and research-stage programs focused on the development of ZFP Therapeutics® for HIV/AIDS, monogenic diseases and stem cell applications, were described in twelve presentations given by Sangamo scientists and collaborators at the 15th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT).

Syneron Medical Ltd. (NASDAQ: ELOS)
, the leading global aesthetic device company, announced today that it will host an investor meeting on Tuesday, May 22, 2012, from 10:30 am to 2:30 pm ET in New York City.

Transgenomic, Inc. (OTCBB: TBIO)
today announced it has achieved CE IVD Mark registration in Europe for the diagnostic use of its proprietary WAVE MCE System and SURVEYOR® Scan KRAS Kit. Analysis of the KRAS gene is critical for treatment decision-making in many cancer types.

Verint® Systems Inc. (NASDAQ: VRNT) today announced that a market-leading provider of comprehensive pharmaceutical services to long-term care facilities is implementing its Impact 360® for Back-Office Operations™ solution--which includes robust workforce management, adherence, desktop and process analytics, data propagation and process guidance, and performance management functionality.



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