GeoVax Phase 2a Clinical Trial Completes Enrollment; Chmbio Files PMA Module II with FDA DPP® HIV Test. Print E-mail
By Staff and Wire Reports   
Monday, 03 October 2011 19:42
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 3, 2011.

GeoVax Labs, Inc. (OTCQB/OTCBB:GOVX), an Atlanta-based biopharmaceutical firm developing vaccines to prevent and fight Human Immunodeficiency Virus (HIV) infections, announced today the completion of enrollment for a Phase 2a clinical trial testing its HIV/AIDS vaccine. The vaccine is being developed for use in uninfected people to prevent infection should they be exposed to the virus.

The trial, designated HVTN 205, is being conducted by the HIV Vaccines Trials Network (HVTN), which is funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. A total of 299 participants are enrolled in HVTN 205.

GeoVax also announced the unblinding of data for neutralizing antibody (Ab) responses in part 1 of HVTN 205 - showing elicitation of unexpectedly high response rates of neutralizing antibody for tier 2 isolates of HIV-1. Of 46 tested vaccine recipients, 50% responded with neutralizing activity for tier 2 clade B isolate RHPA; and 26% with neutralizing antibody for tier 2 clade B isolate SC22.3C2. Neutralizing antibodies can block virus from infecting cells by binding to regions of the virus that mediate entry into cells.

The elicitation of neutralizing antibody for tier 2 viruses is an important result because tier 2 viruses represent viruses that undergo the most frequent transmission from an infected person to an uninfected person. A new highly sensitive test was used for conducting neutralization tests, which were done at the HVTN laboratories at Duke University.

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Chembio Diagnostics, Inc. (OTCQB: CEMI & OTCPK: CEMI), which develops, manufactures, markets and licenses point-of-care diagnostic tests, reports it has filed the second module of its Pre-Marketing Approval (PMA) application to the United States Food & Drug Administration for its DPP® HIV 1/2 Assay which contains the non-clinical data for the product. Chembio’s DPP® HIV 1/2 Assay is a “yes/no” qualitative rapid test for the detection of antibodies to HIV 1 & 2 in oral fluid, finger-stick whole blood, venous whole blood, serum or plasma samples.

The test is intended to be used as an aid in the diagnosis of HIV/AIDS in point-of-care settings such as public health and other clinics, hospital emergency rooms, and physicians’ offices. The DPP® HIV 1/2 Assay delivers visual results within approximately 15 minutes, is simple to use, has a shelf life of 24 months, and does not require refrigeration. The product incorporates Chembio’s patented Dual Path Platform technology as well as a proprietary sample collection system that enables certain unique product features.



Also Monday:




Advanced Cell Technology, Inc. (OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the company’s chairman and CEO, Gary Rabin, will be presenting at the 2011 World Stem Cell Summit on Wednesday, Oct. 5, at the Pasadena Convention Center in Pasadena, Calif.

AdCare Health Systems, Inc. (NYSE Amex: ADK), a nursing home and assisted living company, has been invited to present at the Imperial Capital 5th Annual Global Opportunities Conference.

Alkermes plc (NASDAQ: ALKS) today announced the initiation of a phase 2b study of ALKS 37, an orally active, peripherally restricted opioid antagonist for the treatment of opioid-induced constipation (OIC).

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced that the first patients have been dosed in the Company's phase IIIb trial of XIAFLEX®for the treatment of adult Dupuytren's contracture patients with multiple palpable cords.

BioElectronics Corporation (OTC: BIEL), the maker of inexpensive, disposable drug-free topical pain devices, today announced that Andrew J. Whelan, President, will present at RetailInvestorConferences.com.

Biovest International, Inc. (OTCQB:BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB:ABPI), today announced that Biovest is scheduled to present at the MD Becker Partners Cancer Immunotherapy Conference at the New York Academy of Medicine on October 6th.

CANTEL MEDICAL CORP.'s (NYSE: CMN) Minneapolis, MN based subsidiary, Minntech Corporation, has been named by the Minnesota High Tech Association (MHTA), as one of three finalists in the Life Sciences Award - Established Companies Category for the 2011 Tekne Awards.

CDEX Inc. (OTCBB: CEXI), a leading developer of chemical detection products, using patented technologies for use in healthcare, safety and security markets, announced today the company has shipped the first ValiMed™ G4 drug validation system to a prominent US based global medical technology company.

Chembio Diagnostics, Inc. (OTCQB: CEMI) (PINKSHEETS: CEMI), which develops, manufactures, markets and licenses point-of-care diagnostic tests, reports it has filed the second module of its Pre-Marketing Approval (PMA) application to the United States Food & Drug Administration for its DPP® HIV 1/2 Assay which contains the non-clinical data for the product.

Emergent BioSolutions Inc. (NYSE: EBS) today announced that, in response to solicitation RFP-2011-N-13414, it has received an award to supply the U.S. government with 44.75 million doses of BioThrax® (Anthrax Vaccine Adsorbed) over a period of five years for a total value of up to $1.25 billion.

EnteroMedics Inc., (NASDAQ: ETRM)
, the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that twelve month Caloric Intake Study data and updated clinical results from the Company's VBLOC-DM2 ENABLE (DM2) Study evaluating the Company's second-generation Maestro RC System in the treatment of obesity, diabetes and hypertension will be presented at the 29th Annual Meeting of the Obesity Society October 1-5, 2011 in Orlando, Florida.

FONAR Corporation (NASDAQ: FONR), The Inventor of MR Scanning™, has announced its financial results for the fiscal 2011 year which ended June 30, 2011.

GeoVax Labs, Inc. (OTCQB/OTCBB: GOVX), an Atlanta-based biopharmaceutical firm developing vaccines to prevent and fight Human Immunodeficiency Virus (HIV) infections, announced today the completion of enrollment for a Phase 2a clinical trial testing its HIV/AIDS vaccine.

Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ Dubai: HIK) ("Hikma"), the fast growing multinational pharmaceutical group, today announces that it has acquired 63.9% of Société de Promotion Pharmaceutique du Maghreb S.A. (Casablanca: PRO) ("Promopharm" or the "Company") from a consortium of shareholders, comprising existing management, institutions and related parties, for an aggregate cash consideration of $111.2  million (MAD 912.8 million) and will launch a mandatory tender offer for the remaining 36.1% of the Company.  

Idera Pharmaceuticals, (Nasdaq: IDRA) a biopharmaceutical company developing therapeutics targeting Toll-like Receptors (TLRs) and advancing gene-silencing oligonucleotide (GSO) technology, today announced that Sudhir Agrawal, D.Phil, Chairman and Chief Executive Officer, is scheduled to present at the MD Becker Partners Cancer Immunotherapy: A Long-Awaited Reality in New York City on Thursday, October 6th. Dr. Agrawal will present a corporate overview at 9:15 am ET.

NuPathe Inc. (NASDAQ: PATH)
today announced positive top-line results from NP101-009, its second 12-month, repeat use safety trial for its migraine patch (NP101 or Zelrix).

Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) announced today that on September 30, 2011, the Compensation Committee of its Board of Directors approved the grant of inducement stock options to purchase an aggregate of 133,000 shares of common stock to 7 new employees.

PAREXEL International Corporation (NASDAQ: PRXL) will release financial results for the First Quarter of Fiscal Year 2012 on Monday, October 31, 2011 after the close of the stock market.

Pharmaceutical Product Development, Inc. (Nasdaq: PPDI) today announced that it has entered into a definitive merger agreement under which it will be acquired by affiliates of The Carlyle Group and Hellman & Friedman in an all-cash transaction valued at $3.9 billion, after which PPD will be a private company.

POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announces the selection of Keelin Reeds LLC to assist in the strategic partner search for PA32540, currently in late Phase 3 development.

PROLOR Biotech, Inc. (NYSE Amex: PBTH) today announced that it has received a notice of allowance from the U.S. Patent and Trademark Office (PTO) for a patent application covering the company's long-acting CTP-enhanced human growth hormone (hGH-CTP).

Siemens Healthcare (NYSE: SI) has announced that the Mobilett Mira, the company's first mobile digital X-ray system with a wireless detector, recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and is now commercially available in the U.S.

VIROPRO (VPRO.PK) today announced the appointment of Ms. Michelle Peake to the position of CEO of its wholly-owned subsidiary Alpha Biologics Sdn. Bhd. facility based in Penang, Malaysia.

VIVUS, Inc. (NASDAQ: VVUS)
today announced that multiple abstracts were presented at Obesity 2011:  The 29th Annual Scientific Meeting of The Obesity Society being held in Orlando, Florida.



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