Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.
PRNewswire - December 8, 2000
Initially, the trials will determine the effectiveness of GEDA Plus(R) in preventing five of the most common sexually transmitted diseases - gonorrhea, chlamydia, syphilis, herpes and Trichomonas. According to the World Health Organization, these diseases afflict more than 333 million people annually, which includes about 15 million cases reported each year in the United States. IBC anticipates that this first phase of the trials could be completed in nine months.
The second phase of the clinical trials will determine the effectiveness of GEDA Plus(R) in preventing the deadly HIV virus and will commence upon completion of the first phase. IBC estimates the second phase of the trials will require at least an additional 18 months to complete.
In addition to seeking approval to sell the gel in Brazil, IBC intends to seek approval for Empyrean to sell the microbicidal contraceptive gel in the United States as protection against sexually transmitted diseases other than HIV, once the first phase of all trials required by the FDA has been successfully completed. Subsequently, IBC will seek approval to expand the label claim to include protection against HIV once the second phase has been successfully completed.
The clinical trials in Brazil will be conducted by PAREXEL International Corporation, a leading international clinical research organization, with the cooperation of EDYABE S.A., a South American contract research organization. IBC has agreed to commit up to $10 million to fund Phase III clinical trials.
"GEDA Plus(R) has the potential to become a significant force in the fight against sexually transmitted disease and thereby become the leading product in an estimated $2 billion global market," continued Adamany, "especially considering the recent failure of a competing product to provide protection against HIV. We believe GEDA Plus(R) will be shown to be effective against HIV as well as other sexually transmitted diseases."
GEDA Plus(R) does not contain nonoxynol-9, which is the active ingredient in various potentially competing products that failed to demonstrated efficacy in previous clinical trials. Not only did the products containing nonoxynol-9 fail to provide protection against HIV, but the data suggests that in some situations, nonoxynol-9 might increase the risk of infection due to the genital irritation it causes. Studies performed with GEDA Plus(R) have shown no such irritation.
Empyrean Bioscience has exclusive rights to sell, market and distribute a wide range of GEDA(R) products in the United States based on IBC formulations, including GEDA Plus(R) microbicidal contraceptive gel. Empyrean pays IBC a five percent royalty on net sales within the United States.
IBC has exclusive rights to sell, market and distribute all products using its formulations in Brazil. IBC will pay Empyrean a five percent royalty on net sales within Brazil. The two companies have formed a 50/50 joint venture that will grant third party distributors the right to manufacture, market, sell and distribute products based on IBC formulations in markets outside the United States and Brazil.
"The need for an effective microbicide to prevent the transmission of sexually transmitted diseases has never been greater," said Dr. Thornburgh.
"We remain confident that large clinical trials of GEDA Plus(R) will confirm the favorable results we have obtained in several smaller studies."
Empyrean Bioscience is a consumer products company specializing in the marketing, sale and distribution of innovative personal care products designed to prevent the spread of infectious diseases. The company markets its products under the Preventx(R) and Coleman(R) brand names. For more information, see http://www.empyreanbio.com .
International Bioscience Corporation is a company with revolutionary breakthrough products that it believes will change the medical world and people's lives everywhere. The company's products include GEDA Plus(R), a microbicidal contraceptive gel and Peloderm, a healing, pain reducing wound dressing. For more information, see http://www.intlbio.net .
This press release includes statements that may constitute forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The statements regarding "the first in a series of Phase III clinical trials," "to bring this revolutionary product to market to aid in the prevention of sexually transmitted diseases worldwide," "the trials will determine the effectiveness of GEDA Plus(R) in preventing the five most common sexually transmitted diseases," "IBC anticipates that this phase of the trials could be completed in six to nine months," "will determine the effectiveness of GEDA Plus(R) in preventing the deadly HIV virus and will commence upon completion of the first phase," "IBC estimates the second phase of the trials will require at least 18 months to complete," "IBC intends to seek approval for Empyrean to sell the microbicidal contraceptive gel," "IBC will seek approval to expand the label claim to include protection against HIV," "the clinical trials in Brazil will be conducted," "to commit up to $10 million to fund Phase III clinical trials," "has the potential to become a significant force," "become the leading product," "will be shown to be effective against HIV as well as other sexually transmitted diseases," and "confident that large clinical trials of GEDA Plus(R) will confirm the favorable results" are forward-looking in nature.
These statements are subject to risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Such risks include, among other factors, the success of the clinical trials, regulatory approvals, the acceptability of the potential product in the marketplace, the ability to obtain sufficient capital to fund operations and the outcome of pending litigation. Additional factors, which could cause actual results to differ materially from expectations in the forward-looking statements, are set forth in the Company's Form 10K-SB annual report filed with the Securities and Exchange Commission.
SOURCE Empyrean Bioscience, Inc. Web Site: http://www.empyreanbio.com http://www.intlbio.net
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