BioSante Pharmaceuticals Completes Enrollment in Pivotal Phase III Clinical Trial for Estrogen Gel.LINCOLNSHIRE, Ill. -- BioSante Pharmaceuticals, Inc. (Amex:BPA BPA British Paediatric Association. ) today announced that it has reached its enrollment target of over 450 women in the Company's pivotal, Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the to evaluate the safety and efficacy of Bio-E-Gel(TM) (bioidentical estradiol transdermal gel) for the treatment of moderate-to-severe hot flashes hot flashes Hot flush Gynecology A symptom afflicting 80-85% of middle-aged ♀, first occurring during the perimenopause, continuing with ↓ intensity for yrs, manifesting itself as transient waves of erythema and uncomfortable warmth beginning in the in menopausal women. Hot flashes occur in up to 85 percent of menopausal women. "Completing enrollment in our Phase III Bio-E-Gel trial is an important milestone that brings BioSante one step closer to a new drug application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) and commercialization of Bio-E-Gel," said Stephen M. Simes, president and chief executive officer of BioSante. "We are confident in the potential of Bio-E-Gel to help women better manage the symptoms of menopause." BioSante's randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , 12-week, double-blind, placebo-controlled Phase III trial of Bio-E-Gel is being conducted in the United States and Canada. Current FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. requirements for approval of new estradiol products include one 12-week Phase III clinical trial. The study is evaluating three doses of Bio-E-Gel to maximize the safety profile by identifying the lowest effective dose. The Company expects to complete the trial by the end of Q1 2005. Moreover, BioSante plans to file an NDA with the U.S. Food and Drug Administration (FDA) in mid-2005. About Bio-E-Gel(TM) Bio-E-Gel is a gel formulation of estradiol (bioidentical human estrogen) designed to be quickly absorbed through the skin after topical application on the arms, shoulders, thighs or abdomen, delivering estradiol to the bloodstream evenly over time at minimal dosage and in a non-invasive, painless manner. Estrogen products today are approved for the treatment of menopausal symptoms, including hot flashes and vaginal atrophy vaginal atrophy Atrophic vaginitis, see there . Estrogen products are not approved for and should not be used for the treatment or prevention of heart disease. The current market in the U.S. for estrogen products is approximately $2.0 billion. About BioSante Pharmaceuticals, Inc. BioSante is developing a pipeline of hormone therapy Hormone therapy Treating cancers by changing the hormone balance of the body, instead of by using cell-killing drugs. Mentioned in: Breast Cancer, Thyroid Cancer hormone therapy products to treat both men and women. In addition to Bio-E-Gel(TM), the Company's transdermal gel formulations include LibiGel(TM) (bioidentical testosterone gel) for treatment of female sexual dysfunction sexual dysfunction Inability to experience arousal or achieve sexual satisfaction under ordinary circumstances, as a result of psychological or physiological problems. and Bio-T-Gel(TM) (bioidentical testosterone gel) for treatment of men with testosterone deficiency. The transdermal gel formulations used in the women's gel products are licensed by BioSante from Antares Pharma Inc. (Amex:AIS). BioSante also is developing its calcium phosphate nanotechnology (CAP) for novel vaccines, including biodefense vaccines for toxins such as anthrax and ricin ricin /ri·cin/ (ri´sin) a phytotoxin in the seeds of the castor oil plant (Ricinus communis), used in the synthesis of immunotoxins. ri·cin n. , and drug delivery systems. The current vaccine market is approximately $9 billion and is predicted to triple in size by 2012. Additional information is available online at www.biosantepharma.com. This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. The statements regarding BioSante contained in this press release that are not historical in nature, particularly those that utilize terminology such as "may," "will," "should," "likely," "expects," "anticipates," "estimates," "believes" or "plans," or comparable terminology, are forward-looking statements. Forward-looking statements are based on current expectations and assumptions, and entail various risks and uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements. Important factors known to BioSante that cause actual results to differ materially from those expressed in such forward-looking statements are the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance, and other factors identified and discussed from time to time in BioSante's filings with the Securities and Exchange Commission, including those factors discussed on pages 18 to 25 of BioSante's Form 10-KSB, which discussion also is incorporated herein by reference. |
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