|Alere receives FDA Approval for Alere Determine™; NW Bio Receives Regulatory Decision For Its Brain Cancer Trial In Germany|
|By Staff and Wire Reports|
|Friday, 09 August 2013 19:52|
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 information, announced it has received U.S. FDA approval of its pre-market application (PMA) to market Alere Determine™ HIV 1/2 Ag/Ab Combo in the United States for the detection of HIV-1 p24 antigen and antibodies to HIV-1/HIV-2. The FDA approval allows Alere to market Alere Determine™ HIV 1/2 Ag/Ab Combo as a CLIA (Clinical Laboratory Improvement Amendments) moderately complex medical device.
Alere Determine™ HIV-1/2 Ag/Ab Combo is the first and only FDA-approved rapid point-of-care test that detects both HIV-1/2 antibodies and the HIV-1 p24 antigen, which can appear days after infection and prior to, HIV-1/2 antibodies.
According to the Centers of Disease Control and Prevention (CDC), there are 1.4 million Americans living with HIV, and approximately 207,000 (18%) whose infections have not been diagnosed. In 2010, the CDC estimated that there were 47,500 newly infected people with the virus in the United States, indicating that HIV remains a serious health problem. HIV testing is essential for healthcare and social services to improve the quality of life and survival for persons who have HIV. Individuals who are acutely infected with HIV, which is defined as the interval between the appearance of HIV RNA in plasma and the detection of HIV-1 specific antibodies, contribute disproportionately to HIV transmission. With the use of the Alere Determine™ HIV 1/2 Ag/Ab Combo, HIV can be detected earlier than second and third generation antibody-only tests.
Avi Pelossof, Alere Global President of Infectious Disease, said, "We are pleased that the FDA has issued the approval for Alere Determine™ HIV 1/2 Ag/Ab Combo. Our next step is to complete the CLIA waiver trials with the intention to submit the data in late 2013 or early 2014."
Pelossof added, "The Alere Determine™ Combo can help to identify additional cases that would not be detected using second and third generation antibody-only tests. We anticipate Alere Determine™ Combo to play a critical role in the U.S. to help identify individuals with HIV and to help break the infection cycle."
Northwest Biotherapeutics (NASDAQ: NWBO), a biotechnology company developing non-toxic DCVax® personalized immune therapies for solid tumor cancers, announced it has received a decision from the German regulatory agency (the Paul Ehrlich Institute, or PEI) under which the Company's Phase III clinical trial will be able to proceed in Germany after the Company makes three modifications, none of which affect the body of the trial or the bases for seeking product approval.
Two of the three modifications directed by the PEI involve modest textual matters, as follows:
One of the eligibility criteria for the trial is that patients must have adequate bone marrow function, since the immune cells with which DCVax is made are obtained through a leukapheresis blood draw. Currently the eligibility criteria set a general standard for bone marrow function, and identify a specific quantitative measure as an example ("e.g.,"). The PEI has directed that the "e.g.," be removed and that the same quantitative measure be made into a requirement rather than an example of the requirement. Certain information about the risks and benefits of the DCVax treatment is currently contained in one of the key clinical documents (the Investigator's Brochure). The PEI has directed that the same information also be added into the trial Protocol document. The third modification involves dropping an extra arm of the trial which is gathering data on patients who do not meet the eligibility criteria for enrollment in the body of the trial which will form the basis for any product approval decision.
The extra arm of the trial is for patients who may have unusually aggressive cancer, such that they already have progression (tumor recurrence) by the end of 6 weeks of post-surgery radiation treatments as part of standard of care, when eligibility for the DCVax trial is determined. In these cases, today's imaging technology cannot distinguish between radiation damage or tumor re-growth. These patients are not eligible for the body of the trial, but are offered enrollment in a side group to receive DCVax treatment. This side group is not part of the clinical results or statistics which will form the basis for seeking product approval, but it provides additional data collection. Accordingly, dropping this side group in Germany as directed by the PEI can readily be done without impacting the trial. The trial will continue to include the extra arm in countries other than Germany.
"Initiating our Phase III clinical trial in Germany will be a major expansion and advancement of our lead program," commented Linda Powers, CEO of NW Bio. "We are very excited to receive a favorable decision from the PEI about our Phase III trial, with only three such limited adjustments to be made. We plan to make these modifications right away, and proceed as soon as possible."
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Bioheart, Inc. (OTCQB: BHRT) announced today that it received a validated registration from the FDA for the initial tissue bank listing.
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Boston Therapeutics, Inc. (OTCQB: BTHE), a drug development company focused on complex carbohydrates to treat diabetes and inflammatory diseases, reports its financial results for the second quarter and six months ended June 30, 2013.
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Lannett Company, Inc. (NYSE MKT: LCI) today announced that the company will present at the Canaccord Genuity 33rd Annual Growth Conference on Thursday, August 15, 2013, at 1:30 p.m. Eastern at the Intercontinental Boston Hotel.
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Omeros Corporation (NASDAQ: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products targeting inflammation, coagulopathies and disorders of the central nervous system, today announced its financial results for the second quarter of 2013.
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Swisher Hygiene Inc. (Nasdaq:SWSH) (TSX:SWI), a leading provider of essential hygiene and sanitizing products and services, announced today results for the three-month and six-month periods ended June 30, 2013.
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