pSivida Receives CRL from FDA for ILUVIEN; ARIAD Reports Discontinuation of Phase 2 EPIC Trial Print E-mail
By Staff and Wire Reports   
Friday, 18 October 2013 19:48
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 18, 2013.

pSivida Corp. (NASDAQ: PSDV)
announced its licensee Alimera Sciences, Inc. has received a Complete Response Letter (CRL) for the New Drug Application (NDA) for ILUVIEN® from the U.S. Food and Drug Administration (FDA).

Identifying concerns regarding the benefit to risk and safety profiles of ILUVIEN, the FDA stated that the NDA could not be approved in its present form. To address the clinical and statistical deficiencies identified, the FDA indicated that results from a new clinical trial would need to be submitted, together with at least 12 months of follow-up for all enrolled.



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ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA)
announced it is discontinuing the Phase 3 EPIC (Evaluation of Ponatinib versus Imatinib in Chronic Myeloid Leukemia) trial of Iclusig^® (ponatinib) in patients with newly diagnosed chronic myeloid leukemia. ARIAD and the U.S. Food and Drug Administration mutually agreed that the trial should be terminated because arterial thrombotic events were observed in patients treated with Iclusig. This decision was made in the interest of patient safety based on a recent assessment of data in the clinical trial.

“Our decision to stop the EPIC trial at this time is based on our current evaluation of the safety data in the trial since it was placed on partial clinical hold last week,”stated Timothy P. Clackson, Ph.D., president of research and development and chief scientific officer at ARIAD. "We believe that this is in the best interests of patient safety and the overall development of Iclusig.”

Patients in the EPIC trial are being removed from treatment and will be transferred to the care of their physician. ARIAD announced in early September that fifty percent of patients, or approximately 264 patients, had been enrolled in the EPIC trial by that time. Final enrollment is 307 patients.

The EPIC trial was a randomized, two-arm, multicenter trial that sought to compare the efficacy of ponatinib with that of imatinib in adult patients with newly diagnosed CML in the chronic phase. The trial was being conducted at approximately 150 investigational sites in more than 20 countries. Patients in the trial had to be at least 18 years of age and diagnosed with CML within six months prior to enrollment. Approximately 500 patients were to be randomized 1:1 to the standard dose of ponatinib (45 mg given orally once daily) or imatinib (400 mg given orally once daily). Increasing the imatinib dose to 600 mg or 800 mg per day was permitted. The primary endpoint of the trial was major molecular response at 12 months of treatment.

Iclusig is commercially available in the U.S. and EU for patients with resistant or intolerant CML and Philadelphia-chromosome positive acute lymphoblastic leukemia. ARIAD continues to work with health authorities to make appropriate changes to the Iclusig product labeling to reflect the recently announced safety findings from the pivotal PACE trial that was the basis of its marketing approvals.

Investor and analyst briefing and webcast:  ARIAD management will host a conference call and webcast to discuss these actions today, October 18 at 8:30 a.m. ET. The live webcast can be accessed by visiting the investor relations section of the Company's website at http://investor.ariad.com. The call can be accessed by dialing 866-318-8620 (U.S.) or +1 617-399-5139 (international) and providing the participant code 13718093. A replay of the call will be available on the ARIAD website approximately two hours after completion of the call and will be archived for three weeks.



Also Friday:



Agios Pharmaceuticals, Inc. (NASDAQ: AGIO)
, today announced that the company will present insights into its lead isocitrate dehydrogenase (IDH) program at the at the 2013 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place October 19-23, 2013 in Boston.

Alimera Sciences, Inc., (NASDAQ: ALIM)
, a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that it has received a Complete Response Letter (CRL) for the New Drug Application (NDA) for ILUVIEN® from the U.S. Food and Drug Administration (FDA).

Arrowhead Research Corporation (NASDAQ:ARWR)
, a biopharmaceutical company developing targeted RNAi therapeutics, today announced that it will present data on ARC-520, its hepatitis B drug candidate, at two upcoming scientific conferences.

Avita Medical Ltd. (ASX: AVH) (OTCQX: AVMXY)
Regenerative medicine Company Avita Medical Ltd. (ASX: AVH) (OTCQX: AVMXY) is pleased to report the presentation of results obtained with the use of ReCell® Spray-On Skin® at the recent Clinical Cosmetic & Reconstructive Expo held in London, England 11-12 October, 2013.

Bioanalytical Systems, Inc. (NASDAQ:BASI)
today announced financial results for the third quarter and first nine months of fiscal 2013.

Bionomics Limited (ASX:BNO) (ADR:BMICY)
will present posters on both BNC101 and BNC105 at the American Association for Cancer Research (AACR) International Conference on Molecular Targets and Cancer Therapeutics in Boston.

Brazil Interactive Media, Inc. (OTCQB: BIMI)
, a Brazil-based, interactive TV entertainment, production and broadcasting company, today announced the addition of several new key members to its senior management team.

CEL-SCI Corporation (NYSE MKT:CVM)
today announced that it has received notification from NYSE Regulation dated October 17, 2013 that the Company is now considered to have regained compliance with the listing requirements of the NYSE MKT LLC Company Guide.

Chimerix, Inc. (Nasdaq:CMRX)
, a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced the pricing of an underwritten public offering of 2,476,995 shares of its common stock at a price to the public of $16.50 per share.

Cleveland BioLabs, Inc. (Nasdaq:CBLI)
announced today that because of maturation of its development pipeline and a reduced need for certain services, it has transferred laboratory and preclinical services personnel to Buffalo BioLabs, LLC, an entity affiliated with one of the Company's co-founders, Andrei Gudkov, Ph.D., D. Sci.

CorMedix Inc. (NYSE MKT: CRMD)
, a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiorenal disease,  today announced that it has entered a securities purchase agreement with an existing institutional investor pursuant to which it has agreed to sell 150,000 shares of Series C-1 Non-Voting Convertible preferred stock and a warrant to purchase up to 750,000 shares of common stock, and also entered into a separate securities purchase agreement with another existing institutional investor pursuant to which it has agreed to sell 150,000 shares of Series C-2 Non-Voting Convertible preferred stock and a warrant to purchase up to 750,000 shares of common stock, for aggregate gross proceeds of $3,000,000.  

Dyadic International, Inc. (OTC Pink: DYAI)
, a global biotechnology company focused on the discovery, development, manufacture and sale of enzyme and protein products for the bioenergy, biochemical, biopharmaceutical and industrial enzyme industries, announced today that it has entered into agreements with all of its outstanding promissory note holders to extend their maturity dates to January 1, 2015.  

EncounterCare Solutions (PINKSHEETS: ECSL)
announced today that its subsidiary, CyberCare Health Network, Inc., has released a mobile application allowing both patients and care providers to take pictures of wounds using a cell phone.

Harris & Harris Group, Inc. (Nasdaq:TINY)
, an early-stage, active investor in transformative companies, is pleased to work with Burroughs Wellcome Fund and Research Triangle Foundation to support new thinking in the healthcare space.

IntelliCell Biosciences, Inc. (OTCQB: SVFC)
, a regenerative medicine company utilizing adult autologous vascular fraction cells (SVFCs) derived from the blood vessels in lipoaspirate, announced today the addition of Mr. Sam Khashman to the company's Board of Directors.

Laboratory Corporation of America® Holdings (NYSE: LH)
today announced results for the quarter ended September 30, 2013.

Marrone Bio Innovations, Inc. (Nasdaq:MBII)
, a leading global provider of bio-based pest management and plant health products, announced today that its board of directors has appointed Dr. Pamela Contag and Mr. Les Lyman to the board.

Medical Marijuana, Inc. (OTC Pink:MJNA)
is pleased to inform shareholders and the general public that HempMedsPX™ – a corporate portfolio company of Medical Marijuana Inc. and the exclusive master distributor and contracted marketing company for CannaVest Corp. and Medical Marijuana, Inc. – is augmenting their product line with new cannabidiol (CBD)-rich hemp-based products at Cibdex.com.

Pfizer Inc. (NYSE:PFE)
announced today top-line results from two phase 3b, placebo-controlled studies with Lyrica® (pregabalin) Capsules CV in patients with fibromyalgia (FM) and painful diabetic peripheral neuropathy (DPN), respectively.

Pinacle Enterprise, Inc. (OTCBB: PINS) (OTCQB: PINS)
and its wholly owned subsidiary Alkame Water Inc. are pleased to announce that the Company and Alkame™ branded bottled water products have received kosher certification from Orthodox Union (OU).

Premier, Inc. (Nasdaq:PIN
C) today announced the appointment of Ellen C. Wolf and Stephen R. D'Arcy to its board of directors, effective October 11 and October 18, 2013, respectively.

RCM Technologies, Inc. (Nasdaq:RCMT)
, a premier provider of business and technology solutions designed to enhance and maximize the operational performance of its customers through the adaptation and deployment of advanced information technology, engineering and specialty healthcare services, today announced that it has filed preliminary proxy materials with the Securities and Exchange Commission ("SEC") in connection with RCM's 2013 Annual Meeting of Stockholders ("2013 Annual Meeting") to be held on Thursday, December 5, 2013, at 6:00 p.m., at the offices of Morgan, Lewis & Bockius LLP in Philadelphia, Pennsylvania.

TherapeuticsMD, Inc. (NYSE MKT: TXMD)
announced today that it received the first-place prize for its poster at the The North American Menopause Society (NAMS) 2013 Annual Meeting recently held in Dallas.

ZELTIQ® (Nasdaq:ZLTQ)
, a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology platform, announced today that it plans to release its third quarter 2013 financial results on October 30, 2013 after the market close.



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