EpiCept soars on encouraging leukemia drug analysis. NewCardio reports positive cardiac study results. Cypress Biosciences receives higher offer. Print E-mail
By BioMedReports.com Staff   
Friday, 10 December 2010 20:04

Below is a look at some of the headlines for companies that made news in the healthcare sector on December 10, 2010.


Shares of EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) soared more than 38% today after the company announced the results of a new analysis supporting its leukemia drug, Ceplene, and its positive impact on overall survival and its activity with another drug, interleukin-2 (IL-2). Ceplene is already approved in the European Union for the maintenance of first remission in patients with Acute Myeloid Leukemia (AML) in conjunction with low dose IL-2.

In October 2010 EpiCept announced that it reached agreement with the U.S. Food and Drug Administration for a two-arm, randomized, open-label trial that will compare the efficacy of Ceplene plus low-dose IL-2 to standard practice in this indication. Based on FDA guidance, the primary endpoint of the trial will be overall patient survival. In designing this new trial, EpiCept will be guided by the results of the previous Phase III trial for Ceplene and more particularly by the results of a new subset analysis of 190 patients that were treated aggressively with consolidation therapy before being randomized into the trial. Within this subset of patients, a difference in overall patient survival was seen in favor of Ceplene/IL-2 versus standard of care, suggesting that improved overall survival could be achieved in an adequately powered clinical trial.

As previously announced on December 5, 2010, a poster for Ceplene was presented at the 52nd Annual Meeting of the American Society of Hematology (ASH), which revealed the findings from a Bayesian meta-analysis comparing Ceplene + IL-2 versus IL-2 alone in leukemia free survival in AML patients in remission. The study found that leukemia free survival from IL-2 monotherapy is similar to that of current standard of care, while the benefit of Ceplene +IL-2 over standard of care and IL-2 monotherapy is statistically significant. Researchers stated the conclusion reached was robust with respect to the modeling assumptions. This study helped reinforce the consensus that a further clinical trial that utilizes IL-2 monotherapy is not ethical or feasible. The poster "Incremental Benefit of Histamine Dihydrochloride When Added to Interleukin-2 for Remission Maintenance in Acute Myeloid Leukemia: A Bayesian Meta-analysis" was authored by Scott M. Berry, PhD and Kristine R. Broglio, MS, Berry Consultants, LLC, College Station, TX; Donald A. Berry, PhD, Berry Consultants, LLC and Division of Quantitative Sciences, The University of Texas M.D. Anderson Cancer Center, Houston, TX.

"We were very pleased by the positive response we received at ASH from numerous key opinion leaders in hematology in the U.S., both on the results of the meta-analysis as well as on the potential of Ceplene to profoundly impact the standard of care for AML if approved," said Jack Talley, President and CEO of EpiCept. "We are encouraged by the results of the new analysis we generated from the earlier Phase III Ceplene trial and believe that we have a clear and achievable regulatory path for Ceplene. A successful outcome from the planned U.S. survival trial for Ceplene would, in our view, establish Ceplene as a cornerstone of remission maintenance therapy in the U.S."

Shares of EpiCept jumped 27 cents or 39% to 97 cents.

Shares of NewCardio, Inc., (OTC Bulletin Board:NWCI.ob) surged on heavy volume today after the cardiovascular diagnostic solutions developer, presented results of a blinded drug safety study conducted by the Cardiac Safety Research Consortium (CSRC) to evaluate the performance of QTinno on its "testing" ECG dataset. The CSRC blinded "testing" dataset, comprised of 11,672 electrocardiograms (ECGs) from the moxifloxacin and placebo arms of a recent parallel-group Thorough QT Study. The CSRC blinded study results show, by a variety of analytical approaches, that QTinno accurately detects moxifloxacin-induced QT interval prolongation with statistically significant and substantial reductions in measurement variability compared to sponsor-submitted data. In QT studies, lower measurement variability increases the quality of study results and may enable future studies to be done in a more cost effective manner, thereby potentially reducing expenses for cardiac safety studies, which is a significant value proposition for QTinno users.

Vincent Renz Jr., NewCardio's President and CEO commented, "We are very excited that QTinno was the initial automated cardiac safety solution whose performance was evaluated against the CSRC blinded 'testing' data set, for two reasons. First, based on the QTinno validation studies done to date with partners from Pharma, clinical trial service providers and academia, we expected, and realized, statistically significant results from this blinded drug safety study. QTinno has consistently returned highly accurate results with lower variability than other comparator methods, be it manual, semi-automated or automated, just as it did in the CSRC study. And second, it provided another opportunity for us to enhance our collaborative efforts with the CSRC in utilizing the underlying science and technology of QTinno to advance the current state of cardiac safety testing."

Shares of NewCardio gained 13 cents or 16.88% to 90 cents.

Cypress Bioscience, Inc. (NASDAQ:CYPB) today confirmed that it received a revised offer from hedge fund Ramius LLC to acquire all of the outstanding common shares of Cypress common stock for $5.50 per share in cash. Cypress’ Board of Directors has been actively engaged in evaluating a broad range of strategic alternatives. Cypress’ Board will carefully evaluate the revised Ramius offer as part of its ongoing evaluation.

The offer represents a 29% increase over the hedge fund's initial offer of $4.00 per shares. Shares of Cypress closed Friday trading at $4.93 up 87 cents or 21.43%.

Shares of Beckman Coulter (NYSE:BEC) rocketed $14.99, or 26%, to $72.08 after reports Friday that the diagnostic instruments maker has put itself up for sale. Analysts say that the company could garner more than $5 billion. Reports circled that several competitors and private equity firms have shown interest. Beckman Coulter develops, manufactures and markets products that automate biomedical testing. Hospital laboratories use its diagnostic systems and scientists use its research tools to study biological problems, including causes of disease and new drugs.

Tenet Healthcare (NYSE:THC) shot up more than 55% Friday after it was reported that Community Health Systems (NYSE:CYH) has made an unsolicited $3.3 billion offer for the company. A combination of the two companies would form the largest for-profit hospital player with 176 hospitals in 30 states. In a letter to shareholders on Friday, Tenet says it has rejected the offer. Shares of Tenet closed the day at $6.65, up $2.36. Community Health Systems gained 13% or $4.25 to $35.89.

Also Friday:

The board of directors of Abbott (NYSE:ABT) today declared a quarterly common dividend of 44 cents per share.

ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, has entered into definitive agreements with existing and new accredited investors to sell, in a registered direct offering, an aggregate of approximately 2.3 million shares of its common stock at a price of $2.55 per share for aggregate gross proceeds of $6.0 million.

Amgen (Nasdaq:AMGN) today announced results from new analyses comparing XGEVA™ (denosumab), the first new treatment for advanced cancer patients with bone metastases in nearly a decade to prevent skeletal-related events, to Zometa® (zoledronic acid).

Arena Pharmaceuticals, Inc. (Nasdaq:ARNA) announced today the initiation of dosing in a Phase 1 clinical trial of APD811, a novel oral drug candidate discovered by Arena that targets the prostacyclin receptor for the treatment of pulmonary arterial hypertension, or PAH.

Assisted Living Concepts, Inc. (NYSE:ALC) reported that the previously announced reorganization of its largest shareholder, Scotia Investments Limited, has been completed and that the shares of Class A and Class B Common Stock of Assisted Living Concepts, Inc. previously held by Scotia Investments Limited and its subsidiaries have been transferred to a former affiliate of Scotia Investments, Thornridge Holdings Limited.

InfuSystem Holdings, Inc. (OTCBB: INHI) (OTCBB: INHIW) (OTCBB: INHIU), the leading provider of infusion pumps and associated products and services, announced today that the Board of Directors appointed Jim Froisland as Interim Chief Financial Officer of InfuSystem, following the resignation of Sean Whelan as Chief Financial Officer.

Pfizer Inc. (NYSE:PFE)
announced today that, in the interest of patient safety, it is voluntarily withdrawing Thelin® (sitaxentan) for the treatment of pulmonary arterial hypertension (PAH) in regions where it is approved (the European Union, Canada and Australia).

Savanna East Africa, Inc. (PINKSHEETS: NVAE) (OTCQB: NVAE) is scheduled to release an on-demand Webcast today that is expected to discuss its recently announced acquisition in Kenya as well as provide more detail on two pending acquisitions and a planned operation spinoff in the first quarter of 2011.




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