Pluristem to Receive Clinical-hold Notice From the FDA; FDA Grants Priority Review to Bristol-Myers Squibb and AstraZeneca's Metreleptin Print E-mail
By Staff and Wire Reports   
Tuesday, 04 June 2013 19:10
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 4, 2013.
Pluristem Therapeutics (Nasdaq: PSTI), a leading developer of placenta-based cell therapies, announced it has received notification from the U.S. FDA its United States phase II Intermittent Claudication (IC) study (IND 15038) has been placed on clinical hold due to a serious allergic reaction in a case which required hospitalization.

Out of 74 patients enrolled in Pluristem's trials to date, this is the first case of a serious allergic event. This event occurred in a patient with multiple diseases which may have influenced the severity of the event. The patient was discharged from the hospital the following day, following the resolution of all her symptoms.

The FDA will issue a letter within the next 30 days detailing a list of questions and requests for information from Pluristem.

Zami Aberman, Pluristem's Chairman and CEO, stated, "Once we receive the letter, we will work closely with the FDA to address all issues raised. We are committed to our strategy that our competitive technology advantage be involved in clinical programs for multiple indications."

About a Clinical Hold -- Under FDA regulations, an investigational new drug application (IND) is either allowed to proceed or placed on clinical hold (21 CFR 312.42). A clinical hold is an order issued by the FDA to the applicant to delay a proposed clinical investigation or to suspend an ongoing investigation. A clinical hold may be designated either a complete clinical hold or a partial clinical hold. Once the applicant has submitted a complete response to the clinical hold, the FDA must evaluate the response and decide whether to lift the hold. The FDA has committed itself to respond to the applicant within 30 days.

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Bristol-Myers Squibb Company (NYSE: BMY)
and AstraZeneca (NYSE: AZN) announced that the U.S. FDA has accepted and granted a Priority Review designation for the Biologics License Application (BLA) for metreleptin, an investigational agent for the treatment of metabolic disorders associated with inherited or acquired lipodystrophy (LD), a rare disease estimated to affect a few thousand people around the world, often with an early age of onset.

“The FDA's granting of Priority Review for the metreleptin BLA highlights the significant unmet medical need for patients affected by lipodystrophy and brings us an important step closer to potentially bringing a treatment option to these patients,” said Fred Fiedorek, MD, senior vice president, Head of Development, CV and Metabolics at Bristol-Myers Squibb. “Developing metreleptin for the treatment of lipodystrophy demonstrates Bristol-Myers Squibb and AstraZeneca's continued dedication to scientific innovation and global patient care for people impacted by diabetes and related metabolic disorders.”

The FDA grants Priority Review to medicines that may provide a treatment option where little or no adequate therapy exists. Under the Prescription Drug User Fee Act (PDUFA), the FDA aims to complete its review within an eight-month review cycle, rather than the standard 12-month review cycle.

The primary data supporting the BLA filing are from the National Institutes of Health (NIH) ongoing, open-label trial in adult and pediatric patients with inherited or acquired LD.

Also Tuesday:


Edwards Lifesciences Corporation (NYSE: EW)
, the global leader in the science of heart valves and hemodynamic monitoring, is scheduled to present at two upcoming conferences on Tuesday, June 11, 2013.

Dr. Brad Thompson, President and CEO of Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY), will present a corporate overview of the Company at the 2013 Jefferies Global Healthcare Conference on Thursday, June 6th, 2013 at 11:00 a.m. ET.The conference will take place from June 3rd to 6th in New York, NY.

PAREXEL International Corporation (NASDAQ: PRXL)
announced today that it will be presenting at the William Blair Growth Stock Conference in New York.  Josef von Rickenbach, Chairman and Chief Executive Officer, will be making a presentation on PAREXEL and discussing business developments at 10:40 a.m.  ET on Wednesday, June 12, 2013.

RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL)
, an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, patent-protected, new formulations and combinations of existing drugs, today announced that Guy Goldberg, Chief Business Officer, will present an overview of the Company at the Jefferies 2013 Global Healthcare Conference on Monday, June 3, 2013 at 10:30am EDT at The Grand Hyatt Hotel in New York City.

Verisante Technology, Inc. (TSX VENTURE:VRS)(OTCQX:VRSEF)
, a leader in cancer detection technology, announced today that the Company has released its financial results for the first quarter ended March 31, 2013 .

RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL)
, an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, patent-protected, new formulations and combinations of existing drugs, today reported financial results for the first quarter ended March 31, 2013.

Therapeutic Solutions International, Inc. (OTCQB: TSOI)
announced today the signing of a Letter of Intent with S4S (UK) Limited for exclusive distribution rights for the United States to market U.S. Patented and FDA cleared titratable sleep appliance hardware.

RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL)
, an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, patent-protected, new formulations and combinations of existing drugs, reported that it recently concluded a positive Type B meeting with the U.S. Food and Drug Administration (FDA) regarding its cardio drug RHB-101, a controlled release, proprietary, once-daily formulation of carvedilol, for the treatment of congestive heart failure and hypertension.

Zalicus Inc. (Nasdaq Capital Market: ZLCS)
a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain, today announced that it is advancing Z944, its novel oral T-type calcium channel blocker, into further clinical development in the third quarter of 2013.



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