|Merck Announces FDA Acceptance of BLA for Investigational Allergy Tablet; CytRx Provides Update on Clinical Programs|
|By Staff and Wire Reports|
|Wednesday, 08 May 2013 19:08|
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Biologics License Application (BLA) for its investigational ragweed pollen (Ambrosia artemisiifolia) sublingual allergy immunotherapy tablet has been accepted for review by the U.S. Food and Drug Administration (FDA). On March 27, Merck announced that the FDA had also accepted the BLA for its investigational Timothy grass pollen (Phleum pratense) sublingual allergy immunotherapy tablet. Merck expects the FDA's review for both to be completed in the first half of 2014.
The BLA for Merck's investigational ragweed pollen sublingual allergy immunotherapy tablet is supported by five studies evaluating the efficacy and safety of the tablet in adults, 18 years of age or older, with ragweed induced allergic rhinitis (with or without conjunctivitis).
“Merck has a long history of developing new therapies to help patients with allergic rhinitis,” said Jeffrey A. Chodakewitz, M.D., senior vice president, interim franchise head, Respiratory & Immunology, Merck Research Laboratories. “This regulatory milestone for our investigational ragweed pollen sublingual allergy immunotherapy tablet represents another step in our continued commitment to offering potential new options to allergy specialists and their patients.”
Merck's ragweed pollen sublingual allergy immunotherapy tablet is an investigational sublingual dissolvable tablet designed to help treat the underlying cause of allergic rhinitis by generating an immune response to help protect against the targeted allergen. Merck has partnered with ALK-Abello to develop its sublingual allergy immunotherapy tablets for ragweed pollen, timothy grass pollen and house dust mite in North America.
CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that it will focus on the clinical development of aldoxorubicin and expansion of its oncology pipeline based on its proprietary linker platform technology, following the recommendation of an independent Data Safety Monitoring Committee (DSMC) to discontinue the Phase 2b clinical trial with tamibarotene as a first-line treatment for patients with advanced non-small-cell lung cancer. The recommendation was based on an interim analysis indicating that patients treated with tamibarotene were unlikely to show improved progression-free survival over treatment with approved chemotherapeutic agents. No safety concerns were raised.
Earlier this week, CytRx announced that the independent DSMC for its Phase 2b clinical trial with aldoxorubicin as a first-line treatment for patients with advanced soft tissue sarcoma found no significant safety issues and recommended that the trial should be continued to completion. The Company expects to report results from the Phase 2b clinical trial in the second half of 2013.
“This is an eventful time as we expect to announce data from three clinical trials with aldoxorubicin this year and are making preparations to begin our first pivotal Phase 3 clinical trial with aldoxorubicin,” said Steven A. Kriegsman, CytRx President and CEO. “We see significant opportunities ahead with potential from multiple drug candidates addressing numerous oncology indications. Aldoxorubicin is its own pipeline with demonstrated efficacy in human tumor models of breast, ovarian, lung and pancreatic cancers and renal cell carcinoma (kidney cancer). Our linker platform can be combined with virtually any chemotherapeutic agent and is designed to improve concentration of drug at the site of tumors.
“We are disappointed by the outcome of the tamibarotene trial for our Company, but more importantly for patients. The trial was well-conducted but the DSMC judged that it would not be able to successfully meet its primary endpoint. We will continue to make tamibarotene available on a compassionate use basis for patients with acute promyelocytic leukemia,” he added.
Update on Aldoxorubicin Development
CytRx is preparing to initiate a global, open-label, randomized pivotal Phase 3 clinical trial comparing treatment with aldoxorubicin with approved chemotherapeutic agents for patients with soft tissue sarcoma who have relapsed or were refractory following prior treatment with chemotherapy. A Special Protocol Assessment (SPA) has been granted by the U.S. Food and Drug Administration (FDA) for the pivotal Phase 3 trial. The SPA indicates that the FDA deems the results from a single Phase 3 clinical trial as acceptable to support the regulatory approval, with final marketing approval dependent on the results of the trial and other accomplishments.
In addition to results from the Phase 2b clinical trial with aldoxorubicin, CytRx expects to report data from two additional clinical trials with aldoxorubicin in 2013, both in the second quarter. The first is a Phase 1b clinical trial in patients with advanced solid tumors to determine the maximum tolerated dose (MTD) of a combination of aldoxorubicin and doxorubicin. The clinical trial will continue with the combination aldoxorubicin and doxorubicin administered at the MTD to an expanded group of patients with chondrosarcomas or chordomas to determine safety and preliminary efficacy in these normally chemotherapy-insensitive malignancies. The purpose of this trial is to extend the Company's patent portfolio and potentially increase market penetration with aldoxorubicin for the treatment of patients with solid tumors. The Company also expects to report pharmacokinetic results from an open-label, single-center Phase 1b clinical trial in patient with metastatic solid tumors.
Abbott (NYSE: ABT) will present at the UBS Global Healthcare Conference on Wednesday, May 22, 2013. Thomas C. Freyman, executive vice president, finance and chief financial officer, and Brian Blaser, executive vice president, diagnostics products, will present at 7:30 a.m. Central time.
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") announces the results of the vote on directors held earlier today at its annual meeting of shareholders.
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CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that it will focus on the clinical development of aldoxorubicin and expansion of its oncology pipeline based on its proprietary linker platform technology, following the recommendation of an independent Data Safety Monitoring Committee (DSMC) to discontinue the Phase 2b clinical trial with tamibarotene as a first-line treatment for patients with advanced non-small-cell lung cancer.
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Zalicus Inc. (Nasdaq Capital Market: ZLCS), a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain, today announced that it has entered into a stock purchase agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”) an institutional investor.