|ABRAXANE® Demonstrates Significant Improvement in Advanced Melanoma Patients; Oxygen Biotherapeutics' Update on U.S. Army-Funded Preclinical Studies|
|By Staff and Wire Reports|
|Thursday, 25 October 2012 19:12|
Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) announced abstracts for the upcoming Society for Melanoma Research meeting have been published online in the organization’s official journal at http://onlinelibrary.wiley.com/doi/10.1111/pcmr.12023/abstract. The publication includes an abstract reviewing results from a phase III metastatic melanoma study with ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound).
“Metastatic melanoma presents significant treatment challenges due in part to limited therapies, low survival rates at diagnosis and no advances in chemotherapy in thirty-seven years”
In the randomized, open-label, international study (CA033), ABRAXANE showed a statistically significant improvement in progression-free survival (PFS) in chemotherapy-naïve patients with metastatic melanoma compared to patients receiving dacarbazine chemotherapy (4.8 vs. 2.5 months, respectively (HR:0.792; 95.1% CI: 0.631, 0.992; P=0.044)). An interim analysis of overall survival, the secondary endpoint, shows a trend in favor of the ABRAXANE arm compared to treatment with dacarbazine (12.8 and 10.7 months, respectively (HR:0.831; 99.9% CI: 0.578, 1.196; P=0.094)).
“Metastatic melanoma presents significant treatment challenges due in part to limited therapies, low survival rates at diagnosis and no advances in chemotherapy in thirty-seven years,” said Dr. Evan M. Hersh, lead principal investigator and Professor of Medicine at the University of Arizona College of Medicine and Arizona Cancer Center, Tucson, AZ. “Despite advances with targeted treatment and immunotherapies, there is still a need for new agents including chemotherapy treatments for patients with metastatic melanoma.”
The safety profile of ABRAXANE observed in the CA033 study is comparable with other ABRAXANE pivotal clinical trials. The most common grade ≥3 treatment-related adverse events reported in ≥10% patients were neuropathy (ABRAXANE: 25% vs. dacarbazine: 0%), neutropenia (ABRAXANE: 20% vs. dacarbazine: 10%). The median time to neuropathy improvement with ABRAXANE was 28 days.
These results will be presented at the Society for Melanoma Research 2012 Congress on Sunday, November 11th, in Hollywood, CA.
Oxygen Biotherapeutics (NASDAQ: OXBT), a development stage biomedical company currently focused on developing its proprietary perfluorocarbon-based intravenous emulsion, Oxycyte®, as a treatment for a variety of emergent ischemic conditions, today reported that the U.S. Army-funded preclinical program that was established to address the U.S. Food and Drug Administration (FDA) questions regarding the product, is well underway with several important milestones complete or nearing completion. Perfluorocarbon emulsions as a class have been shown to cause transient thrombocytopenia in animals and humans and, because of emulsion particle clearance mechanisms, have raised questions regarding their potential impact on normal immune system function. To continue the clinical development of Oxycyte in the United States, the FDA has requested studies to explore in detail the safety profile of Oxycyte with respect to these putative effects. With this preclinical work, OBI has moved several steps closer to addressing the questions posed by the FDA regarding thrombocytopenia, platelet function, and immunocompetence.
Clinical studies of Oxycyte in TBI patients, placed on-hold by the FDA, are being conducted outside the United States. The second cohort of a global Phase IIB study will be launched by the end of the year. Data from the preclinical program may support data collected in patients and provide the company with a regulatory path forward in the United States. Regardless, however, the company is advancing its strategy to allow for licensing the product in any number of countries. If successful, Oxycyte could become an essential element of emergency care for TBI patients by providing fast and effective delivery of oxygen to the brain.
“The majority of the first year of this preclinical program was spent engaging contract research organizations, developing and finalizing study designs and protocols, procuring reviews and approvals from the FDA and Department of Defense for changes to the originally planned studies. In addition, a number of highly technical bioanalytical methods and animal models had to be developed. We are pleased to announce that most of the studies under the program are underway, and we are beginning to review data from recently completed studies,” said Michael Jebsen, President and Chief Executive Officer. “The successful validation of GLP GC/MS bioanalytical methods and the completion of the PK studies was a critical first step to evaluating and interpreting the data generated from the platelet and immune models currently underway.”
Amarantus BioSciences, Inc. (OTCQB: AMBS), a biotechnology company developing new disease-modifying treatments and diagnostics for Parkinson's disease and Traumatic Brain Injury centred on its proprietary anti-apoptosis therapeutic protein MANF, today announced that the Company has received positive behavioural efficacy data for MANF in a neurorestoration 6-hydroxydopamine (6-OHDA) rat model of Parkinson's disease.
ArQule, Inc. (NASDAQ: ARQL) today announced that it will report its financial results for the third quarter of 2012 on Thursday, November 1, 2012 at 7:00 a.m. eastern time.
Biogen Idec Inc. (NASDAQ: BIIB) today announced third quarter 2012 financial results, delivering revenue growth of 6 percent to $1.4 billion and non-GAAP diluted Earnings Per Share (EPS) growth of 19 percent.
BIOLASE, Inc. (NASDAQ: BIOL) the World's leading biological dental laser manufacturer and distributor, today announced that Frederick Furry, Chief Operating Officer and Chief Financial Officer, will make an investor presentation at the Singular Research 7th Annual "Best of the Uncovereds" Conference on Thursday, November 1, 2012, at 9:30 a.m. Pacific Time.
Celgene Corporation (NASDAQ: CELG) reported total revenue of $1,419 million for the third quarter of 2012, a 14 percent increase from the same period in 2011.
Cerus Corporation (NASDAQ:CERS) announced today that Chrystal Menard has been appointed chief legal officer, effective December 3, 2012.
Columbia Laboratories Inc. (Nasdaq: CBRX) will hold a conference call on November 8, 2012, to discuss financial results of the three-month period ended September 30, 2012.
CONMED Corporation (NASDAQ: CNMD) today announced financial results for the third quarter ended September 30, 2012.
Cytori Therapeutics (NASDAQ: CYTX) today announced two independent investigator-sponsored and funded cell therapy clinical studies in Japan have been approved by the Ministry of Health, Labor and Welfare under the Guidelines on Clinical Research Using Human Stem Cells.
Durata Therapeutics (NASDAQ: DRTX) today announced that it has completed its target enrollment for DISCOVER 2 (“Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response”), the second global, Phase 3 clinical trial of Durata’s lead product candidate, dalbavancin, under investigation for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria.
Dyadic International, Inc. (OTC Pink: DYAI), a global biotechnology company, today announced that it will report its financial results for the third quarter ended September 30, 2012 after market close on Thursday, November 8, 2012 and will host a conference call at 5:00 p.m. Eastern Time to discuss those results.
eHealth, Inc. (NASDAQ: EHTH), the leading online source of health insurance for individuals, families and small businesses, today announced its financial results for the third quarter ended September 30, 2012.
Exelixis, Inc. (NASDAQ: EXEL) will release its third quarter 2012 financial results on Wednesday, November 7, 2012, after the markets close.
GeckoSystems Intl. Corp. (PINKSHEETS: GOSY) (http://www.geckosystems.com/) announced today that as a result of their letter to FINRA on September 7, 2012 -- regarding an ongoing naked short selling (NSS) of GeckoSystems stock -- FINRA has launched an official investigation. GeckoSystems alleged in their letter with supporting documents to FINRA, that George Iveagh MacLeod is orchestrating this NSS.
GenSpera, Inc. (OTCBB:GNSZ) announced that its lead drug, G-202, has been selected by the Statewide Clinical Trials Network of Texas (CTNeT) for evaluation in a Phase II clinical trial in patients with hepatocellular carcinoma (HCC).
Given Imaging (NASDAQ: GIVN) today announced that the company will host a conference call on Wednesday, November 7, 2012 at 9:00am ET, 4:00pm Israel time to discuss third quarter 2012 financial results.
Given Imaging Ltd. (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced new data that was presented at the American College of Gastroenterology 2012 annual meeting that highlighted the economic value of using its newly acquired SmartPill GI monitoring system in evaluating patients with both upper and lower functional gastrointestinal symptoms.
Greatbatch, Inc. (NYSE: GB), today announced results for its third quarter ended September 28, 2012.
GTx, Inc. (NASDAQ: GTXI) today announced that it will host a conference call and webcast to provide a corporate update and discuss the Company's third quarter 2012 financial results on Thursday, November 8, at 9:00 a.m. Eastern Time.
Insulet Corporation (NASDAQ: PODD), the leader in tubing-free insulin pump technology with its OmniPod® Insulin Management System, today announced the appointment of John A. Fallon, M.D., F.A.C.P. to the Company's board of directors.
Mannatech, Incorporated (NASDAQ: MTEX), the leading innovator and provider of naturally sourced supplements based on Real Food Technology® solutions, announced the ongoing launch of its newest nutritional supplement, NutriVerus powder, into many of its international markets.
MMRGlobal, Inc. (OTCBB: MMRF) ("MMR") today announced that it is already in the process of delivering the second group of 25 MMRPro systems pursuant to an agreement with a reseller of medical products and services to healthcare professionals as announced by the Company on October 1, 2012.
mPhase Technologies, Inc. (OTCBB: XDSL) today released a multi-purpose video of its new product targeted toward the automotive and marine industry.
NeuroMetrix, Inc. (Nasdaq: NURO), a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, today reported business and financial highlights for the quarter and nine months ended September 30, 2012.
Orexigen Therapeutics, Inc. (Nasdaq: OREX) today announced that it has priced an underwritten public offering of 11,000,000 shares of its common stock at a price of $5.50 per share.
Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today announced that financial results for the company's third quarter ended September 30, 2012, will be released before the market opens on Thursday, November 1, 2012.
PDI, Inc. (Nasdaq: PDII) today announced the signing of a new multi-year Sales Services contract with a Top 5 global pharmaceutical company to provide a dedicated sales team that will target primary care physicians, pediatricians and psychiatrists.
Strike Axe, Inc. (OTCBB: SKAX) today announced it has entered into an Asset Purchase Agreement with Mega-Pro, Inc. as part of its strategy to become the leader in the Nutritional Enhancement and Supplements Industry.
Techne Corporation (NASDAQ: TECH) announced that its Board of Directors has decided to pay a dividend of $0.30 per share for the quarter ended September 30, 2012.
Unilife Corporation ("Unilife" or "Company") (NASDAQ: UNIS; ASX: UNS) announced today that it intends to release its financial results for the fiscal 2013 first quarter ended September 30, 2012 after market trading ends on Tuesday, October 30, 2012.
United Therapeutics Corporation (NASDAQ: UTHR) announced today that it will release its third quarter 2012 financial results before market open on Thursday, November 1, 2012.
ViroPharma Incorporated (Nasdaq: VPHM) reported today its financial results for the third quarter ended September 30, 2012.
Zalicus Inc. (NASDAQ: ZLCS), a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain, today announced that Sanofi provided an update on the development status of Prednisporin™ (FOV1101) during the course of Sanofi’s quarterly financial and R&D pipeline update on October 25, 2012.