Abbott Announces Data Evaluating Efficacy with HUMIRA; CEL-SCI Ongoing Phase 3 Trial Showed No Safety Concerns Print E-mail
By Staff and Wire Reports   
Monday, 22 October 2012 19:22
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 22, 2012.

Abbott (NYSE: ABT)
announced results from an analysis of three-year long-term data from an ongoing open-label extension of the HUMIRA® (adalimumab) ULTRA 1 and ULTRA 2 studies. Adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to certain other medications and were treated with HUMIRA were evaluated for symptom improvement for up to three years. In this long-term analysis, ulcerative colitis activity was assessed using the Partial Mayo score, which does not include endoscopic findings. Results showed:

A reduction in observed mean Partial Mayo score (a measure of disease activity that ranges from 0 to 9) from 5.9 at the time of first dose of HUMIRA to 1.4 at week 172 of HUMIRA therapy. A 55.3 percent remission rate, per Partial Mayo score at week 60 of the extension study (reflecting 112 weeks from lead-in study baseline), as assessed in the intent-to-treat patients who enrolled in the open-label study extension. The data were presented this week at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Las Vegas, Nevada, and the United European Gastroenterology Week (UEGW) Annual Meeting in Amsterdam, The Netherlands.

"We know ulcerative colitis can be a long-term, disruptive and difficult-to-treat disease," said lead investigator Jean-Frederic Colombel, M.D., professor of gastroenterology and hepatogastroenterology, director of the Department of Hepatogastroenterology, Hopital Huriez, Lille, France. "These results provide valuable information and insight to further study the long-term use of adalimumab in the treatment of ulcerative colitis."

UC is an inflammatory bowel disease marked by ulcers in the colon and may lead to life-threatening complications. It is estimated that 25 percent of patients with UC may undergo surgical removal of the colon during their lifetimes, leaving patients with a permanent colostomy or ileal pouch.

These results are encouraging, as they follow the recent regulatory approvals in the U.S. and Europe of HUMIRA for inducing and sustaining clinical remission in adult patients with moderately to severely active UC who demonstrated an inadequate response to immunosuppressant therapy," said John Medich, Ph.D., divisional vice president, clinical development, Immunology, Abbott. "Abbott is committed to further investigate the long-term use, efficacy and safety of HUMIRA in these patients."


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CEL-SCI Corporation (NYSE: CVM)
announced an interim review of the safety data from its open label, randomized, controlled, pivotal Phase III study of Multikine (Leukocyte Interleukin, Injection) investigational immunotherapy by an Independent Data Monitoring Committee (IDMC) raised no safety concerns. The IDMC also indicated that no safety signals were found that would call into question the benefit/risk of continuing the study.

CEL-SCI considers the results of the IDMC review to be important since studies have shown that up to 30% of Phase III trials fail due to safety considerations and the IDMC's safety findings from this interim review were similar to those reported by investigators during CEL-SCI's Phase I-II trials. Ultimately, the decision as to whether a drug is safe is made by the FDA based on an assessment of all of the data from a trial.



Also Monday:




Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC)
, a leader in the field of regenerative medicine, today announced treatment of the fourth patient, the first in the second patient cohort, in its European clinical trial for Stargardt’s Macular Dystrophy (SMD).

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 third quarter fiscal year 2012 financial results after the market close on Wednesday, November 7, 2012.

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY)
and Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that they have formed an exclusive alliance to develop and commercialize RNAi therapeutics targeting transthyretin (TTR) for the treatment of transthyretin-mediated amyloidosis (ATTR) in Japan and other Asia-Pacific countries.

BioMed Realty Trust, Inc. (NYSE: BMR)
today announced it will report results for its third quarter ended September 30, 2012 after the market closes on Thursday, November 1, 2012.

CEL-SCI Corporation (NYSE MKT: CVM)
announced today that an interim review of the safety data from its open label, randomized, controlled, pivotal Phase III study of Multikine (Leukocyte Interleukin, Injection) investigational immunotherapy by an Independent Data Monitoring Committee (IDMC) raised no safety concerns.

DARA BioSciences, Inc. (NASDAQ: DARA)
, a specialty pharmaceutical company focused on oncology and oncology supportive care products, announced today it has launched Soltamox® (tamoxifen citrate) oral solution in the United States. Soltamox is a new treatment option for breast cancer patients who are prescribed tamoxifen therapy.

Derma Sciences, Inc. (Nasdaq: DSCI)
, a medical device and pharmaceutical company focused on advanced wound care, today reported that based on a meeting held last week with the U.S. Food and Drug Administration (FDA), the Company plans to begin its Phase 3 program in December 2012 in support of a New Drug Application (NDA) for DSC127 for treatment of diabetic foot ulcers.

Fuse Science, Inc. (OTCQB: DROP)
, (www.fusescience.com) an innovative company that possesses proprietary delivery technology set to redefine how consumers receive energy, medicines, vitamins and minerals, today provides further details on their most recent research results.

Genetic Immunity (OTCBB: PWRV)
, a leader in immunotherapy technology, announced the peer-reviewed publication on the Company's groundbreaking nanotechnology and details on its potential for the cure of HIV.

Given Imaging Ltd (NASDAQ: GIVN)
, a world leader in GI medical devices and pioneer of capsule endoscopy, today announced data from numerous studies highlighting the value of ManoScan™ high resolution manometry in assessing esophageal and anorectal muscle function.

Given Imaging Ltd. (NASDAQ: GIVN)
, a world leader in GI medical devices and pioneer of capsule endoscopy, today announced three new studies confirming the value of PillCam® COLON 2 in a range of clinical settings, including as an evaluation tool for triaging FIT-positive patients for subsequent colonoscopy, for patients who are unable to undergo standard colonoscopy, and to assess the extent and severity of ulcerative colitis.

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI)
will host a conference call on Tuesday, November 6, 2012, at 8:30 a.m. ET.

Insulet Corporation (NASDAQ: PODD)
, the leader in tubeless insulin pump technology with its OmniPod® Insulin Management System, announced plans to release its financial results for the third quarter of 2012 on November 8, 2012 after the close of the financial markets.

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND)
today announced that it will receive a $2 million milestone payment from Merck, known as MSD outside the United States and Canada, under the terms of a development and license collaboration for the development of dinaciclib.

MMRGlobal, Inc. (OTCBB: MMRF) ("MMR")
, a leading provider of Personal Health Records (PHRs), MyEsafeDepositBox storage solutions and MMRPro document management and imaging systems for healthcare professionals, today announced that in the third quarter ending September 30, 2012, the Company had sales, deferred revenue and signed customer purchase agreements for more than one million dollars driven by MMRPro.

Nordion Inc. (TSX: NDN) (NYSE: NDZ)
today provided an update regarding proceedings to determine the potential award of costs from Atomic Energy of Canada Limited (AECL) associated with Nordion’s arbitration with AECL over the cancelled MAPLE project.

Nordion Inc. (TSX: NDN) (NYSE: NDZ)
extended its contract with its primary Medical Isotopes customer, Lantheus Medical Imaging, Inc. (LMI) for the supply of Molybdenum-99 (Mo-99).

NPS Pharmaceuticals, Inc. (NASDAQ: NPSP)
, a biopharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today reported data related to the seven patients who achieved complete independence from parenteral nutrition (PN) and/or intravenous fluids (IV) while on long-term Gattex® (teduglutide) therapy in STEPS 2, a 24-month, open-label study in adult short bowel syndrome (SBS).

Pfizer Inc. (NYSE: PFE)
today announced its intention to acquire NextWave Pharmaceuticals, a privately held, specialty pharmaceutical company focused on the development and commercialization of unique products for the treatment of attention deficit/hyperactivity disorder (ADHD) and related central nervous system (CNS) disorders.

Puma Biotechnology, Inc. (NYSE:PBYI)
, a development stage biopharmaceutical company, announced that the underwriters for its public offering of 7,500,000 shares of its common stock at $16.00 per share have elected to exercise in full their option to purchase up to an additional 1,125,000 shares of common stock at the public offering price, less the underwriting discount.

Regenerative medicine company AvitaMedicalLtd. (ASX: AVH), (OTCQX: AVMXY) announced that further to Australian Stock Exchange announcements on 5 September 2012 and 16 October 2012 and following today's Shareholder Meeting it is pleased to announce the appointments of Jeremy Curnock Cook and Matt McNamara to the board of Avita Medical.



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