Aeterna Zentaris to Discontinue Phase 3 Trial in Multiple Myeloma; ZIOPHARM Initiates Phase 2 Study of Ad-RTS IL-12 Print E-mail
By Staff and Wire Reports   
Monday, 11 March 2013 19:27
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 11, 2013.

Aeterna Zentaris Inc. (NASDAQ: AEZS)
announced an independent Data Safety Monitoring Board ("DSMB") has recommended discontinuing the ongoing Phase 3 study comparing the efficacy and safety of perifosine to placebo when combined with bortezomib (Velcade®) and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma. Based on the outcome of its pre-planned interim analysis of efficacy and safety, the DSMB recommended that patient enrollment be stopped and the study discontinued. The DSMB reported that it was highly unlikely the study would achieve a significant difference in its primary endpoint, progression free survival; no safety concerns were raised.

Juergen Engel, PhD, Aeterna Zentaris President and CEO stated, "We are obviously disappointed with the outcome of the interim analysis as reported to us by the DSMB, both from a patient and Company perspective. However, we remain focused on other significant opportunities such as our Phase 3 trial in endometrial cancer and Phase 2 trials in breast, prostate and bladder cancer with AEZS-108, our NDA filing for AEZS-130 as an oral diagnostic test for growth hormone deficiency in adults, as well as our earlier-stage oncology compound, AEZS-120."


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ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP)
, a biopharmaceutical company focused on the development and commercialization of new cancer therapies, announced the initiation of a randomized, open label Phase 2 clinical study of Ad-RTS IL-12 in combination with palifosfamide to treat patients with non-resectable recurrent or metastatic breast cancer.

The two-part, multi-center U.S. study will enroll up to 68 patients with non-resectable, recurrent or metastatic breast cancer who have visible lesions or lesions accessible by injection. The study is designed to assess the safety and efficacy of the drug combination of Ad-RTS IL-12 and palifosfamide. Ad-RTS IL-12 is a targeted and controlled DNA-based therapeutic designed to express interleukin-12 (IL-12), a protein important for an immune response to cancer.  Palifosfamide is a potent bi-functional DNA alkylating agent.  

Part one of the two-part study will consist of a safety assessment for Ad-RTS IL-12 and palifosfamide, alone or in combination. Part two will consist of an efficacy evaluation of the Ad-RTS IL-12 only arm and the combination arm. The primary endpoint of the study is rate of progression-free survival at 16 weeks. Secondary endpoints include objective response rate, duration of response and evaluation of pharmacodynamic tumor markers.

"Several recent breakthroughs in cancer treatment are based on the hypothesis that the immune system plays a central role in suppressing both cancer's growth and metastasis," said John Nemunaitis, M.D., lead investigator and Executive Medical Director, Mary Crowley Medical Research Center. "For breast cancer, the positive correlation of survival with immune response in the tumor elicited by non-immune treatments has only recently been elucidated, and this understanding hints at the potential for exciting new breakthroughs in this still underserved population. We look forward to participating in this study and to gaining further insight regarding the combined effect of Ad-RTS IL-12, a selectively controlled immunotherapy, and palifosfamide, a potent bi-functional DNA alkylating agent."

Jonathan Lewis, M.D., Ph.D., Chief Executive Officer of ZIOPHARM, added, "This study has exciting potential, both for this difficult-to-treat indication and for our synthetic biology platform, in which Ad-RTS IL-12 is the lead program. Building on preclinical work supporting a synergistic effect between Ad-RTS IL-12 and palifosfamide, and the clinical findings from our ongoing Phase 2 melanoma study, we believe the combination of Ad-RTS IL-12 and palifosfamide has the potential to be quite impactful in breast cancer."



Also Monday:




Abattis Bioceuticals Corp. (CNSX: FLU) (OTC: ATTBF)
, announces that it will not be proceeding with its $600,000 non-brokered private placement as previously announced in its Press Release dated February 12, 2013 as it is canvassing other avenues of financing through strategic relationships to prevent any dilution for its shareholders.

Abbott (NYSE: ABT)
today announced positive long-term results for the company's innovative Absorb™ Bioresorbable Vascular Scaffold (BVS).

Aeterna Zentaris Inc. (NASDAQ:  AEZS) (TSX: AEZ)
(the "Company") today announced that an independent Data Safety Monitoring Board ("DSMB") has recommended discontinuing the ongoing Phase 3 study comparing the efficacy and safety of perifosine to placebo when combined with bortezomib (Velcade®) and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma. Based on the outcome of its pre-planned interim analysis of efficacy and safety, the DSMB recommended that patient enrollment be stopped and the study discontinued.

Alimera Sciences, Inc. (NASDAQ: ALIM)
("Alimera"), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that it will release its fourth quarter and fiscal year 2012 financial results after the market close on Thursday, March 21, 2013.

AmbiCom Holdings, Inc. (OTCQB: ABHI)
, a leading designer and developer of wireless products for the medical and automotive industries, and a distributor of innovative healthcare products, today announced for the second quarter ending January 31, 2013, a reported revenue of $785,717 with net income of $154,322 or $0.015 per share.

BioElectronics Corporation (OTC Pink: BIEL)
, the maker of unique inexpensive, patented, anti-inflammatory pain reliever devices announced that the OTC Bulletin, the leading global trade publication for over-the-counter healthcare products has chosen its ActiPatch® Musculoskeletal Pain Relief Therapy as the first runner-up for the "Most Innovative New OTC Product."

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST)
and Astellas Pharma Inc. (Tokyo: 4503) today announced that they entered into an agreement under which Cubist obtains the rights to ceftolozane in certain Asia-Pacific and Middle East territories from Astellas.

Edwards Lifesciences Corporation (NYSE: EW)
, the global leader in the science of heart valves and hemodynamic monitoring, announced the three-year results of a pivotal clinical study of severe aortic stenosis patients at high-risk for surgery.

GeoVax Labs, Inc. (OTCQB: GOVX)
, an Atlanta-based biotechnology company developing innovative, patented HIV/AIDS vaccines, today announced its financial results for the year ended December 31, 2012 and provided a business update.

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI)
will be presenting at the 25th Annual ROTH Conference on March 18, 2013, at 3:00 p.m. PT (6:00 p.m. ET) in Laguna Nigel, CA.

Insmed Incorporated (NASDAQ: INSM)
, a biopharmaceutical company focused on developing and commercializing inhaled therapies for patients battling serious orphan lung diseases that are often life-threatening, today announced that the Company will release financial results for the three and twelve months ended December 31, 2012, before the opening of the stock market of Monday, March 18, 2013.

Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX)
, a biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease, today announced that a conference call will be held tomorrow, Tuesday, March 12, 2013 at 8:30 a.m. EDT to discuss the Company's fourth quarter and year-end 2012 financial results and provide a business outlook for 2013.

Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX)
, a biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease (the "Company"), today announced its results for the fourth quarter and year ended December 31, 2012.

Laboratory Corporation of America® Holdings (LabCorp®) (NYSE:LH)
today announced that Adam H. Schechter, Executive Vice President and President, Global Human Health, Merck, has been appointed to its Board of Directors, effective April 1, 2013.

mPhase Technologies, Inc. (OTCBB: XDSL)
announced today that it will be pursuing a broad array of government funding opportunities to collaborate with the U.S. Army for further development of its smart surface technology for products including reserve batteries and drug delivery systems and supercapacitors.

Micro Imaging Technology, Inc. (OTCQB: MMTC)
announced that on March 7th the Travis County Texas District Court granted the Company's motion to dismiss a lawsuit filed by Alpine MIT Partners, LLC (Alpine) in May 2012.

Guy Sebastian, one of Australia's most well-known recording artists, today commented on a recent story in "The Australian" (www.mmrglobal.com/au) concerning the National E-Health Transition Authority (NEHTA), which has refused to respond to numerous requests from U.S. lawyers representing MMRGlobal, Inc. (OTCQB: MMRF) with regard to MMR's investigation of possible infringements of its Australian patents surrounding Personal Health Records ("PHRs").

Neurocrine Biosciences, Inc. (Nasdaq: NBIX)
announced today that Tim Coughlin, Chief Financial Officer of Neurocrine Biosciences, will be presenting at the 25th Annual Roth Conference in Laguna Niguel.  

SurgiCount Medical, Inc., the wholly owned operating subsidiary of Patient Safety Technologies, Inc. (OTCBB:PSTX), today announced that Michael Roux has joined the Company in the position of Vice President of Product Management.

Rexahn Pharmaceuticals, Inc. (NYSE MKT: RNN)
, a clinical stage biopharmaceutical company focused on developing first in class therapies for the treatment of cancer, announced today that its new Chief Executive Officer Dr. Peter Suzdak and Chief Financial Officer Ted Jeong are scheduled to make an investor presentation at ROTH Capital Partners’ 25th Annual ROTH Conference on Wednesday, March 20, at 12:30 pm Pacific Time.

Sirona Biochem Corp. (TSX VENTURE:SBM) (OTCQX:SRBCF) (FRANKFURT:ZSB)
announced today it has signed a material transfer agreement (MTA) with French-based VitamFero, a veterinary healthcare company. VitamFero, a member of Genopole®, will test Sirona Biochem's proprietary biological preservation technology with a goal to extend the storage time of its live attenuated animal vaccines.

SK3 Group, Inc. (OTC Pink: SKTO)
today announces that it has acquired Medical Greens ™ and has changed its business model to focus purely in the medical marijuana space.

Tengion, Inc. (OTCQB: TNGN)
, a leader in regenerative medicine, today announced it will host a conference call and live audio webcast on Monday, March 18, 2013, at 9:00 a.m. EDT to provide a business update and discuss its fourth quarter and full year 2012 financial results.

VistaGen Therapeutics, Inc. (OTCQB: VSTA
), a biotechnology company applying stem cell technology for drug rescue, predictive toxicology and drug metabolism assays, today announces it will feature key developments involving CardioSafe 3D™, its pluripotent stem cell-based bioassay system for heart toxicity, in a poster presentation at the Society of Toxicology's 52nd Annual Meeting, the world's premier toxicology conference, in San Antonio, Texas, on March 11, 2013, at 7:30 am PDT.



"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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