YM Biosciences Offers Interim Results from Jak Inhibitor CYT387 Study; Sanofi, Regeneron Begin Enrollment in PCSK9 Print E-mail
By Staff and Wire Reports   
Monday, 05 November 2012 20:07
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 5, 2012.

YM BioSciences Inc. (NYSE: YMI)
reported interim results from the Phase I/II study of CYT387, a JAK1/JAK2 inhibitor currently being evaluated for the treatment of myelofibrosis, which were included in an abstract submitted to the American Society of Hematology in August 2012. Updated results will be presented in an Oral Session at the 2012 Annual Meeting of the American Society of Hematology to be held in Atlanta, Georgia on December 9, 2012.

The CYT387 Phase I/II study enrolled 166 patients across six study sites. At the time the ASH abstract was submitted, the median duration of follow-up was 16.1 months (ongoing) with a range of 0.7 to 31.0 months (ongoing).

* Durable transfusion independence responses were observed in more than half of the RBC transfusion dependent subjects with a maximal transfusion-free period exceeding two years and ongoing.  In addition, the percentage of all subjects requiring RBC transfusions substantially decreased over the treatment period. * Treatment with CYT387 resulted in rapid and sustained reductions in splenomegaly with a maximal response duration approaching two years. * The majority of subjects reporting constitutional symptoms at baseline experienced complete resolution or marked improvement by six months with measurable improvement within the first month of therapy. * Higher transfusion independence and spleen response rates were seen in the 300mg dose group compared to the 150mg QD or 150mg BID dose groups. * While 90% of subjects reported at least one treatment-related AE, the majority were reported as Grade 1.

For the first 60 consecutively enrolled subjects for whom the most mature data is available, the median follow-up period was 21.5 months (ongoing) with a range of 2.9 to 31.0 months (ongoing).

* The anemia and spleen response rates in these subjects, per IWG-MRT (International Working Group for Myeloproliferative Neoplasms Research and Treatment), were 59% and 48%, respectively. * Among 33 of these subjects who were RBC transfusion dependent by IWG-MRT criteria, 70% achieved a minimum 12-week period without transfusions, with a maximal transfusion-free period of greater than two years and ongoing.


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Sanofi (NYSE: SNY)
and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the ODYSSEY OUTCOMES trial, a Phase 3 cardiovascular outcomes trial (CVOT) with SAR236553/REGN727 is now recruiting patients. SAR236553/REGN727 is an investigational subcutaneously administered, fully-human antibody that is being evaluated for its impact on lowering low-density lipoprotein cholesterol (LDL-C) by targeting PCSK9 (proprotein convertase subtilisin/kexin type 9).

The ODYSSEY OUTCOMES trial will enroll approximately 18,000 patients, who recently suffered an acute coronary syndrome (ACS), from 49 countries across six continents. With the start of this study, eleven trials are now recruiting in the global SAR236553/REGN727 Phase 3 program.



Also Monday:



Align Technology, Inc. (NASDAQ: ALGN)
today announced that executives of Align Technology are scheduled to speak at upcoming financial conferences.

A.P. Pharma, Inc. (OTCBB: APPA.OB)
, a specialty pharmaceutical company, today reported financial results for the quarter ended September 30, 2012 and highlighted recent corporate progress.

Array BioPharma Inc. (NASDAQ: ARRY)
today announced that data will be presented on two drug candidates, ARRY-520, a KSP inhibitor, and ARRY-614, a dual p38/Tie2 inhibitor, at the 2012 Annual Meeting of the American Society of Hematology (ASH) in Atlanta, Georgia.

athenahealth, Inc. (NASDAQ: ATHN)
, a leading provider of cloud-based practice management, electronic health record (EHR), and care coordination services to medical groups and health systems, today announced details regarding its Fifth Annual Investor Summit.

Avita Medical Ltd. (ASX: AVH) (OTCQX: AVMXY)
today announced that it will be presenting at the upcoming SoCalBio Investor Conference & Exhibition.

Baxter International Inc. (NYSE: BAX)
has ranked first among U.S. healthcare companies in Newsweek magazine’s Green Rankings for the fourth time since the list’s inception in 2009.

BioClinica®, Inc. (NASDAQ: BIOC)
, a global provider of clinical trial management solutions, today announced that TauRx Therapeutics has signed agreements with BioClinica to use Trident IWR/IVR and Imaging Core Lab (ICL) solutions to support its upcoming Phase III clinical trials.

BIOLASE, Inc. (NASDAQ: BIOL)
, the world's leading dental laser manufacturer and distributor, today reported unaudited financial results for the three- and nine-months ended September 30, 2012.

BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX)
, a biopharmaceutical development company, announced today that it will release its unaudited financial results for the quarter ended September 30, 2012 on Wednesday, November 14, 2012, before the U.S. markets open.

Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B)
, a multinational manufacturer and distributor of life science research and clinical diagnostic products, announced today that it was awarded a three-year sole source group purchasing contract for its blood bank reagents from the Premier healthcare alliance.

BioRestorative Therapies, Inc. (OTCBB: BRTX)
, a life sciences company focused on stem cell based cellular therapies for various personal medical applications, announced today that its common stock has begun trading on the OTC Bulletin Board.

Cadence Pharmaceuticals, Inc. (NASDAQ: CADX)
, a biopharmaceutical company focused on acquiring, in-licensing, developing and commercializing proprietary products principally for use in the hospital setting, today reported financial results for the third quarter and nine months ended September 30, 2012.

Can-Fite BioPharma (TASE: CFBI, OTC: CANFY)
, a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases,announced today that it has received a FINRA quotation clearance of its Level 1 American Depository Receipts (ADRs).

Celldex Therapeutics, Inc. (NASDAQ: CLDX)
today announced upcoming data presentations at the Society of Neuro-Oncology’s 17th Annual Scientific Meeting and Education Day to be held in Washington, DC from November 15 through November 19, 2012.

Compugen Ltd. (NASDAQ: CGEN)
today reported financial results for the third quarter ending September 30, 2012.

Durata Therapeutics (NASDAQ: DRTX)
today announced that the U.S. Food and Drug Administration (FDA) has designated dalbavancin as a Qualified Infectious Disease Product (QIDP).

ExamWorks Group, Inc. (NYSE: EXAM)
, a leading provider of independent medical examinations ("IMEs"), peer reviews, bill reviews and related services, today reported financial results for the third quarter of 2012.

Hemp, Inc.'s (PINKSHEETS: HEMP)
(www.hemp.com) subsidiary Marijuana, Inc. announced today a 20-year agreement for the worldwide marketing rights to cannabinoid medicinals using a uniquely effective and safe delivery system.

IGI Laboratories, Inc. (NYSE Amex: IG)
, a New Jersey based topical generic pharmaceutical company, announced today that the Company will launch its first IGI labeled generic products later this year.

Imaging Diagnostic Systems, Inc. (OTCBB: IMDS)
, a pioneer in laser breast imaging, announced today that it has shipped a CTLM® system to Euromedica Hospital in Baia Mare, Romania.

ImmunoCellular Therapeutics, Ltd. (NYSE MKT: IMUC)
today announced that John S. Yu, MD, Interim Chief Executive Officer, will present a corporate overview and business update at the Lazard Capital Markets 9th Annual Healthcare Conference on November 14, 2012 at 11:00 am ET at the Pierre Hotel in New York City.

Incyte Corporation (Nasdaq: INCY)
announced today it will present at the Jefferies 2012 Global Healthcare Conference on Thursday, November 15 at 3:00 p.m. (GMT) / 10:00 a.m. (EST) in London.

Lannett Company, Inc. (NYSE MKT: LCI)
today announced that it has made a donation to the American Red Cross to support Hurricane Sandy relief efforts.

Medicure Inc. (TSX VENTURE:MPH) (PINKSHEETS:MCUJ)
, is pleased to announce that its wholly-owned subsidiary, Medicure Pharma, Inc., has entered into an agreement with Seyer Pharmatec Inc. for the sale and marketing of AGGRASTAT® (tirofiban HCl) within the Commonwealth of Puerto Rico.

Medidata Solutions (NASDAQ: MDSO)
announced that Eileen Schloss, a human resources and business administration executive with more than 25 years of experience and executive leadership, has been named executive vice president of human resources.

Medisafe 1 Technologies Corp. (OTCBB: MFTH)
, a developer of patented technologies that physically prevent unauthorized administration of prescription medications, announced today that the final pages which includes the review of the licensed contract by both parties for the closing of a $7MM non-exclusive perpetual license sale agreement have been postponed due to Hurricane Sandy.  

MEI Pharma, Inc. (Nasdaq: MEIP)
, an oncology company focused on the clinical development of novel therapies for cancer, announced today that it has obtained commitments to purchase $27.5 million of its common stock and warrants in a private placement.

MMRGlobal, Inc. (OTCBB: MMRF)
(the "Company" or "MMR") today announced that while Superstorm Sandy pounded the East Coast, the United States Patent and Trademark Office issued another health information technology patent to MMR.

NuVasive, Inc. (NASDAQ: NUVA)
, a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today that due to the continued uncertainty of transportation in New York City, the Company's Investor Event has been moved from Wednesday, November 7, 2012 to Wednesday, November 14, 2012.

Omeros Corporation (NASDAQ: OMER)
today reported positive data from the second of its two pivotal Phase 3 clinical trials evaluating OMS302 in patients undergoing intraocular lens replacement surgery.

Osiris Therapeutics, Inc. (NASDAQ: OSIR), the leading stem cell company focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets, announced today its results for the third quarter ended September 30, 2012.

PDI, Inc. (Nasdaq: PDII)
, today reported financial and operational results for the third quarter ended September 30, 2012.

Pharmacyclics, Inc. (Nasdaq: PCYC)
today reported financial results and recent developments for its fiscal 2013 first quarter ended September 30, 2012.

RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX)
(“the Company” or “RegeneRx”) today announced that it has received a Notice of Allowance of a U.S. patent for the use of Thymosin beta 4 (Tβ4), certain fragments, isoforms, derivatives and analogues to treat patients with glaucoma and elevated intraocular pressure (IOP).

Response Genetics, Inc. (Nasdaq: RGDX)
, a company focused on the development and sale of molecular diagnostic tests for cancer, announced today the launch of testing for ROS1 gene rearrangements.

VolitionRx Limited (OTC: VNRX)
, a life sciences company focused on developing blood-based diagnostic tests, today announced preliminary findings from its ongoing internal clinical trials of the NuQ® diagnostic platform.

Walgreens (NYSE: WAG) (Nasdaq: WAG)
had October sales of $6.00 billion, a decrease of 2.1 percent from $6.13 billion for the same month in fiscal 2012.

YM BioSciences Inc. (NYSE MKT: YMI, TSX: YM)
, a drug development company advancing hematology and cancer related products, today reported interim results from the Phase I/II study of CYT387, a JAK1/JAK2 inhibitor currently being evaluated for the treatment of myelofibrosis, which were included in an abstract submitted to the American Society of Hematology in August 2012.



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