Cleveland BioLabs wins huge contract from DoD, FDA reviewing safety of Actos diabetes drug Print E-mail
By Mary Davila   
Friday, 17 September 2010 19:15
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 17, 2010.

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.

Glaxo kidney cancer drug shrinks thyroid tumors-study - In a small study, GlaxoSmithKline's (GSK.L) cancer drug Votrient helped shrink tumors in nearly half of patients with an advanced form of thyroid cancer, U.S. and international researchers said on Friday.

For many, the effect of the kidney cancer pill, known generically as pazopanib, lasted for more than a year, said Dr. Keith Bible of the Mayo Clinic in Rochester, Minnesota, whose findings were published in Lancet Oncology.

"These responses that occur in half of all patients are very durable. The majority, in fact two-thirds, last greater than one year," Bible said in a video interview on clinic's website.

The study was done in 37 patients with the most aggressive form of differentiated thyroid cancer. Many patients with these types of cancers can be cured with surgery and radioiodine. But 5 percent of these patients develop a rapidly progressing life-threatening disease that has few treatment options.

U.S. invests in drug to protect against radiation - Tiny biotech Cleveland BioLabs Inc (CBLI.O) has won a $45 million contract from the Department of Defense to conduct clinical trials of a drug to prevent cell damage in the event of nuclear attack. The experimental drug has already been shown to protect mice and monkeys from the damaging effects of radiation. If it works in people, it would be the first drug of its kind.

In animals, the drug has been shown to protect bone marrow and cells in the gut from being destroyed by radiation. "There are no drugs which protect humans from radiation," Michael Fonstein, the company's chief executive officer, said in a telephone interview.

The drug works by interfering with a process of programmed cell death called apoptosis -- basically a form of cell suicide. This helps the body rid itself of damaged cells,

Fonstein said interfering with this process appears to strengthen the body's ability to recover from radiation exposure. The contract with the Defense Department will give the company $14.8 million to develop the drug. It includes an option for the government to spend $30 million on the drug if it wins U.S. regulatory approval.[ID:nSGE68G0I9]. The company already is on a fast-track with the U.S. Food and Drug Administration to have its drug sped through the regulatory approval process.

Fonstein said the drug, known as CBLB502, could be approved for use in humans by mid-2012. That gives the company most of 2011 to ramp up manufacturing, complete animal and safety studies, giving the FDA another six months to complete its review. The compound is made from a salmonella protein that naturally makes cells resistant to cell suicide.

US FDA reviewing safety of Actos diabetes drug - The U.S. Food and Drug Administration said on Friday it was reviewing if Takeda Pharmaceutical Co Ltd's (4502.T) blockbuster diabetes drug Actos may be linked to bladder cancer.  Actos is the Japanese drugmaker's top-selling product with sales of about $4 billion a year, but the pill is due to face generic competition after it loses U.S. patent protection in January 2011.  The FDA said early data from an ongoing Takeda study showed no overall association with Actos and bladder cancer.

But an increased risk of bladder cancer was seen among patients with the longest Actos exposure and the highest cumulative doses.  The preliminary results are based on 5-year data from an ongoing 10-year trial by Takeda.  "At this time, FDA has not concluded that Actos increases the risk of bladder cancer," the agency said in a statement.  Patients should not stop taking Actos unless told to do so by their doctor, the agency said.  

Takeda said the results were early, and the company was committed to completing the 10-year study to get a better picture of bladder cancer rates.

Also Friday:

Alere Inc. (NYSE:ALR), a global leader in enabling individuals to take charge of their health at home through the merger of rapid diagnostics and health management, announced today that it will attend the UBS Global Life Sciences Conference being held September 20 through 22, 2010 at the Grand Hyatt, Park Avenue at Grand Central, New York.

Antares Pharma, Inc. (NYSE Amex: AIS) today announced that Dario Carrara, Ph.D. has resigned from his position as Senior Vice President and Managing Director Phamaceutical Group in Muttenz, Switzerland.

Aradigm Corporation (OTCBB:ARDM) ("Aradigm") today announced it is presenting data on September 22, 2010, from its Phase 1 studies at the ERS Annual Congress in Barcelona, Spain.

Biodel Inc. (Nasdaq:BIOD) announced today the appointment of Arthur Urciuoli to the company's board of directors.  

Bohai Pharmaceuticals Group, Inc. (OTCBB/OTCQB:BOPH), a China-based pharmaceutical company engaged in the production, manufacturing and distribution of Traditional Chinese Medicine (TCM) in China, today announced the availability of its archived presentation slides and audio feed from the company's presentation at the Rodman & Renshaw Global Investment Conference earlier this week.

Cleveland BioLabs, Inc. (NASDAQ:CBLI) today announced that it will host a conference call at 10:00 a.m. EDT on September 20 to discuss recent corporate developments.

CNS Response (OTCBB: CNSO) today announced that CEO George Carpenter will be presenting at JMP Securities Fifth Annual Healthcare Industry Conference to be held Monday, September 27, through Tuesday, September 28, at the New York Palace Hotel in New York, NY.

Cleveland BioLabs, Inc. (NASDAQ:CBLI) today announced that it was awarded a $45 million contract (including options), from the United States Department of Defense (DoD) Chemical Biological and Medical Systems (CBMS) Medical Identification and Treatment Systems (MITS) to develop and stockpile CBLB502 as a medical radiation countermeasure.

CytoGenix, Inc. (Pink Sheets:CYGX) today announced that it has initiated the process of testing CytoGenix's novel liner DNA technology on ferrets, with the expectations of a positive result, furthering the development of the vaccine candidate.

Daxor Corporation (NYSE Amex: DXR), a medical instrumentation and biotechnology company, today announced that a research report derived from a study using the Daxor Blood Volume Analyzer (BVA-100) was presented at the annual Heart Failure Society of America (HFSA) conference in San Diego, CA.

GeckoSystems Intl. Corp. (PINKSHEETS:GCKO) announced today due to their recent expansion of transparency to their shareholders, some of those shareholders had time proven strategies to force naked short squeezes, i.e. shares sold but not owned.Management believes this practice to be artificially depressing GCKO's price per share.

CYTOGENIX, INC. (Pink Sheets:CYGX), today announced that it will hold a conference call to discuss significant positive developments and the aggressive forward plans for CYGX.

Healthmed Services, Ltd. (OTCQB:HEME) (PINKSHEETS: HEME), an innovative software development company, is pleased to announce the launch of a new software technology that has the capability of modernizing remote patient access through the use of handheld devices.

Heathrow Natural Food & Beverage, Inc. (PINKSHEETS:HRNF) is pleased to announce that it has started the process of bringing the company to full reporting status on the Pink Sheets (Current Information).

HORIZON HEALTH INTERNATIONAL CORP. (PINK SHEETS:HZH) (the Company) is pleased to announce the FDA Label application of Enteric Lactoferrin.

Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today that data will be presented on denufosol tetrasodium, an investigational therapy for cystic fibrosis (CF), during oral and poster presentations at the European Respiratory Society (ERS) Annual Congress September 18 - 22, 2010 in Barcelona, Spain.

Medtronic, Inc. (NYSE: MDT), today announced its schedule of events for Transcatheter Cardiovascular Therapeutics (TCT) 2010, which takes place Sept. 21-25 in Washington, D.C.

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced today that it has transferred exclusive license rights to Proximagen Limited (AIM: PRX) for a series of compound hits related to the CXCR4 target with application for a number of indications including those related to the central nervous system.

Lorus Therapeutics Inc. (TSX:LOR) (OTCBB:LRUSF) ("Lorus" or the "Corporation"), a biopharmaceutical company specializing in the research and development of pharmaceutical products and technologies for the management of cancer, today announced that it has filed a preliminary short form prospectus in each of the provinces of Canada in connection with a distribution to its shareholders of rights exercisable for units of the Corporation (the "Rights Offering").

Medco Health Solutions, Inc. (NYSE:MHS) on Thursday completed its acquisition of United BioSource Corporation (UBC) in an all-cash transaction valued at approximately $730 million, creating a complementary and comprehensive research organization that extends Medco's core capabilities in data analytics and research to accelerate pharmaceutical knowledge – advancing patient safety and contributing to the body of evidence-based medicine.

Medex, Inc. (PINKSHEETS: MDXX) today announced that on September 27, 2010 the Company will issue updated financials reflecting the closing of the previously announced Creative Rehab Technology Services, Inc. and Bee Mobile, Inc. acquisitions.

Medtronic, Inc. (NYSE: MDT) announced that data from a multicenter, prospective, randomized, blinded, feasibility trial published today show promise for occipital nerve stimulation (ONS) for treating medically refractory chronic migraines and support the need for further controlled study of the treatment.

Pharmasset, Inc. (Nasdaq:VRUS) announces that management will present at the UBS Global Life Sciences Conference to be held September 20-22, 2010 at the Grand Hyatt, New York, NY.

Walgreens (NYSE: WAG) (NASDAQ: WAG), the nation’s largest retail provider of flu immunization services, and “The Dr. Oz Show,” the popular nationally-syndicated daily talk show featuring Emmy Award-winning host Dr. Mehmet Oz, are teaming up to educate the public about the importance of flu prevention.

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