Siga shares soar as co allays concerns on government contract; Oncolytics Announces Phase 2 of REOLYSIN® Reaches Primary Endpoint Print E-mail
By Staff and Wire Reports   
Friday, 09 December 2011 20:42
Below is a look at some of the headlines for companies that made news in the healthcare sector on December 9, 2011.

Shares of Siga Technologies Inc (NASDAQ:SIGA) jumped 34 percent on Friday, a day after board member Fran Townsend responded to allegations of unfair practices in the awarding of a multi-billion dollar government contract to the pharmaceutical company.

In May, Siga was awarded a $433 million contract to supply 1.7 million doses of its ST-246 smallpox drug for the strategic national stockpile by the U.S. Department of Health and Human Services.

However, in June two Congressional committees started probing allegations that Siga shareholder and financier Ron Perelman's political connections helped the company secure the deal.

"There has been a lot of political overhang on the stock because of all the news that has come out and I think the stock is up because Fran was able to address some of those issues," said Noble Financial Capital Markets analyst Nathan Cali.

In an interview with CNN on Thursday, Siga director Townsend said the contract was given in a competitive process, but rival Chimerix did not met the requirements at the time of the contract award.

Siga's ST-246 smallpox drug works by blocking the ability of the virus to spread to other cells and is seen as a protection against a potential biodefense threat.


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Oncolytics Biotech Inc., (NASDAQ:ONCY)
, announced interim data from a Phase 2 clinical trial using intravenous administration of REOLYSIN® in combination with gemcitabine (Gemzar®) in patients with advanced pancreatic cancer (REO 017) indicated that the clinical study had successfully reached its primary endpoint, and that the drug combination is active.

To date, eight patients of 13 evaluable patients in the study had stable disease (SD) for 12 weeks or longer, for a clinical benefit rate (complete response (CR) + partial response (PR) + SD) of 62%. An additional patient had an unconfirmed PR of less than six weeks.

The study is using a one sample, two-stage design. In the first stage, 17 patients were to be enrolled, and best response noted.  If less than three responses (defined as CR or PR or SD for 12 weeks or more) were observed, the study would have concluded that the combination was inactive and been terminated. If three or more responses were observed among the 17 patents, the study would enroll an additional 16 patients for a total of 33 evaluable patients.  As previously disclosed, this initial endpoint was met after six evaluable patients were enrolled. If at least eight responses were observed out of 33 patients, the study would have reached its primary endpoint and conclude that the drug combination is active.

"These results far exceeded our initial expectations, having met the primary endpoint in a study designed to enroll 33 patients with just over a third of enrolment completed," said Dr. Matt Coffey, Chief Operating Officer of Oncolytics. "We will continue to enroll in this study to evaluate the progression free survival of the patient group, and will continue testing REOLYSIN with various chemotherapeutic agents including gemcitabine and carboplatin/paclitaxel across multiple trials to further understand its potential in the treatment of pancreatic cancer."


Also Friday:


Abiomed, Inc. (NASDAQ: ABMD)
, a leading provider of breakthrough heart support technologies, today presented its expanded heart recovery strategy along with new initiatives that are expected to enhance strong, multi-year double digit sales and earnings growth.

Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
(the "Company") today announced positive preclinical data in triple-negative breast cancer (TNBC) for its highly selective Erk 1/2 inhibitor anticancer compound, AEZS-131.

BioSpecifics Technologies Corp. (NASDAQ: BSTC)
, a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® in the U.S. and XIAPEX® in Europe and Eurasia, today announced the appointment of  George Gould, Esq., to its Board of Directors effective December 6, 2011.

Cell Therapeutics, Inc. (Nasdaq and MTA:CTIC)
(the "Company") today announced that it has entered into an agreement to sell, subject to customary closing conditions, $20 million of shares of its Series 14 Preferred Stock and warrants to purchase shares of its common stock in a registered offering to two institutional investors.

CytoSorbents Corporation (OTCBB: CTSO)
, a critical care-focused therapeutic device company using blood purification to treat life threatening illnesses, announced today that it has signed a purchase agreement for the sale, from time to time, of up to $8.5 million of its common stock to Lincoln Park Capital Fund, LLC ("LPC"), a Chicago-based institutional investor.

Gilead Sciences, Inc. (Nasdaq:GILD)
today announced topline Phase 3 clinical trial results showing that elvitegravir, an integrase inhibitor being evaluated for the treatment of HIV-1 infection, was non-inferior to the integrase inhibitor raltegravir after two years (96 weeks) of therapy in treatment-experienced patients.

Edwards Lifesciences Corporation (NYSE: EW)
, the global leader in the science of heart valves and hemodynamic monitoring, today will provide investors with information on the initiatives expected to result in strong double-digit sales and earnings growth in 2012.

Exact Sciences Corp. (Nasdaq: EXAS) today announced that it has completed its previously announced underwritten public offering of its common stock at a price of $8.00 per share to the public.

Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible catheter robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced that it has secured a $30 million debt facility through Oxford Finance and Silicon Valley Bank.

ICBS Ltd., (OTCPK: ICBT), updates shareholders.

League Now Holdings Corp (OTCBB: LNWZ) announced today that it has signed a letter of intent to acquire Infiniti Systems Group, an information technology services firm.

OncoSec Medical Incorporated (OTCBB: ONCS), a biotechnology company developing advanced-stage OMS ElectroOncology therapies to treat skin cancer and other solid tumor cancers, today announces that Punit Dhillon, President and CEO, will be presenting at the 22nd Annual Oppenheimer Healthcare Conference.

Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing Tovaxin®, a novel T-cell therapy for multiple sclerosis (MS), today announced that Neil K. Warma, President and Chief Executive Officer, will present at the Oppenheimer 22nd Annual Healthcare Conference on Wednesday, December 14, 2011, at 11:40 a.m. EST.

PURE Bioscience, Inc. (NASDAQ: PURE) today announced that it will report results for the first quarter of fiscal year 2012 after market close on Thursday December 15, 2011.

Rosetta Genomics, Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announced that the New York State Department of Health has approved miRview® mets² for testing on patient samples from the state. New York is the only U.S. state that requires an independent regulatory review process for laboratory developed tests.

SDIX™ (NASDAQ: SDIX), today announced that it has successfully completed its previously announced sale of the assets of its water quality division to Modern Water plc for $4.5 million.

Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, affirmed today that the U.S. Food & Drug Administration (FDA) has granted FUSILEV® (levoleucovorin) “Orphan Drug” exclusivity for use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) andAlios BioPharma, Inc.today announced the initiation of two clinical studies for the nucleotide analogues ALS-2200 and ALS-2158, which are inhibitors of the hepatitis C NS5B polymerase.



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