Calypte Biomedical Initiates Africa Clinical Trials Program
First Trial Begins in Uganda PLEASANTON, Calif., Feb. 15 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (Amex: HIV) today announced that it has initiated a clinical trial program of its Aware(TM) rapid HIV-1/2 test platform in Africa. The first trials are being conducted in the Republic of Uganda HIV/AIDS Reference and Quality Assurance Laboratory (HRL), Uganda Virus Research Institute, in Entebbe. The trial will evaluate the sensitivity and specificity of the Company's rapid HIV 1/2 Antibody Tests using; Blood, Oral Fluid and Urine as a specimen.
The trials will evaluate approximately 350 subjects and are being performed under the direction of Dr. Benon Biryahwaho, Laboratory Coordinator at the Uganda Virus Research Institute. This study represents the first regulatory trials to be performed on Aware(TM) tests in sub-Saharan Africa. The Company expects data collection to be completed in the second quarter of this year. Contingent upon positive results from the trial, the Company expects to file for regulatory approval in Uganda by mid-2005.
"Getting these trials underway is an important milestone for Calypte," stated Dr. J. Richard George, President and CEO of Calypte. "We have made great efforts to adhere to our timelines to bring these tests to market, and we are pleased to kick off the African regulatory effort with Dr. Biryahwaho, who has long been a central figure in the Ugandan HIV control effort."
Dr. Benon Biryahwaho commented, "We have continued to assess new technologies for the detection of HIV/AIDS in order that the Ugandan Public should benefit from the most advanced scientific developments in the delivery of AIDS services and care. HIV/AIDS testing empowers people to be informed and hence make appropriate choices. In Uganda, the problem is access and equity. Calypte has made it easier by formulating simple rapid technologies."
The Company intends to initiate additional regulatory trials in key African and Far East markets over the course of 2005. Additionally, the Company expects to begin clinical trials in the coming months utilizing its first commercial application of the technology acquired from Ani Biotech in October 2004. These additional studies using the Ani platform will be initially conducted by Dr. Biryahwaho in the coming months and will continue in other key markets throughout 2005.
Dr. George added, "We believe the Ani format will provide additional options to the African market. The technology transfer for the rapid HIV-1/2 tests using the Ani platform has occurred much quicker than initially expected. We have been able to successfully transfer the technology to our Rockville manufacturing facility, allowing us to qualify both platforms and initiate the Ani trials in Uganda in the coming months. The Ani platform is well suited for both the professional markets as well as over-the-counter applications and represents the future platform for all of the Calypte's diagnostic endeavors."
"We have been gratified by the progress that has been made and the cooperation that we have received from various regulatory agencies in our most important target countries in the region, and will issue further updates as these efforts continue," concluded Dr. George.
About Uganda:
Uganda, located in sub-Saharan Africa has a population of over 26 million according to the U.S. Central Intelligence Agency Fact book. According to the UNAIDS 2004 report on the global AIDS epidemic, as of the end of 2003, approximately 530,000 adults and children living with HIV/AIDS, down from an estimated 620,000 two years prior. The Company estimates that foreign and donor agency sources including USAID, the Global Fund and the World Bank, funded over $100 million in 2004 for AIDS testing and treatment in Uganda. It is estimated that over 1 millions HIV diagnostic tests were conducted in Uganda in 2004, most of these rapid tests.
About Calypte Biomedical:
Calypte Biomedical Corporation, headquartered in Pleasanton, California, is a healthcare company focused on the development and commercialization of diagnostic testing products for the detection of sexually transmitted diseases. Calypte specializes in novel tests such as the HIV-1 Incidence EIA as well as tests that can determine HIV antibody status without the need for blood. Calypte is engaged in developing new diagnostic test products for the rapid detection of HIV and other sexually transmitted diseases. Calypte believes that there is a significant need for rapid detection of such diseases globally to control their proliferation, particularly in lesser-developed countries, which lack the medical infrastructure to support laboratory-based testing. Calypte believes that testing for HIV and other sexually transmitted infectious diseases may make important contributions to public health, and could increase the likelihood of treating those with undetected HIV and other sexually transmitted diseases.
Statements in this press release that are not historical facts are forward-looking statements within the meaning of the Securities Act of 1933, as amended. Those statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements reflect management's current views, are based on certain assumptions and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to, the Company's ability to obtain additional financing and access funds from its existing financing arrangements that will allow it to continue its current and future operations and whether demand for its test products in domestic and international markets will continue to expand. The Company undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in the Company's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact the Company's success are more fully disclosed in the Company's most recent public filings with the U.S. Securities and Exchange Commission ("SEC"), including its annual report on Form 10-KSB for the year ended December 31, 2003 and its subsequent filings with the SEC.
Company Contact: Investor Relations Contact: Richard George, CEO Tim Clemensen, (925) 730-7200 Rubenstein Investor Relations email: rgeorge@calypte.com Phone: (212) 843-9337 email: tclemensen@rubensteinir.com SOURCE Calypte Biomedical Corporation -0- 02/15/2005 /CONTACT: Richard George, CEO of Calypte Biomedical Corporation, +1-925-730-7200, rgeorge@calypte.com; Tim Clemensen of Rubenstein Investor Relations, +1-212-843-9337, tclemensen@rubensteinir.com, for Calypte Biomedical Corporation/ /Web site: http://www.calypte.com / (HIV)
CO: Calypte Biomedical Corporation ST: California IN: MTC HEA SU: PDT
NM -- NYTU143 -- 4327 02/15/200509:56 ESThttp://www.prnewswire |