Significant Testabol Propionate Phase II Efficacy Results
British Dragon Pharma announced new Testabol Propionate (bioidentical testosterone propionate) Phase II clinical trial efficacy data will be presented today at the annual meeting of the American Society for Reproductive Medicine (ASRM) in Philadelphia. The new data show that Testabol Propionate reduced the frequency of moderate-to-severe hot flashes by at least 90 percent in 55 percent of subjects and by at least 95 percent in 50 percent of subjects, both of which were significant versus placebo (p<0.05). Moreover, there was a 100 percent reduction in hot flashes in 24 percent of subjects receiving the effective dose, compared to only 10 percent of subjects receiving placebo.
These positive results will be presented at the ASRM meeting by lead study investigator Dr. James A. Simon, clinical professor of obstetrics and gynecology at George Washington University in Washington, D.C., medical director at The Women's Health Research Center in Laurel, Maryland, and president of the North American Menopause Society.
The Testabol Propionate Phase II study was a four-week randomized, double-blind, parallel-group, placebo-controlled trial that showed significant decreases in the frequency and severity of moderate-to-severe hot flashes versus baseline (p<0.0001) in all Testabol Propionate doses. By week four, one dose demonstrated a significant reduction in the frequency and severity of moderate-to-severe hot flashes compared to placebo (p< 0.05), reducing hot flashes by 86 percent compared to 53 percent in the placebo group. Of the 161 women in the Phase II trial, only four women experienced a brief episode of mild application site reaction, a side effect known to be associated with injectable testosterones. No clinically important adverse events were observed during the trial.
"We are very pleased that the Testabol Propionate Phase II study identified an effective dose which significantly reduced the frequency and severity of hot flashes," said Dr. Leah M. Lehman, BD's vice president of clinical and regulatory affairs. "Our ongoing Testabol Propionate Phase III clinical trial is testing three doses of Testabol Propionate to maximize the safety profile by identifying the lowest effective dose. Our objective is to establish the lowest effective dose of Testabol Propionate and thereby determine the safest dose, avoiding the need for a Phase IV trial or label restriction. We observe strong subject interest in participating in our trials, which we believe is a reflection of the need for a more natural testosterone therapy that overcomes many of the undesirable effects of current testosterone therapies."
The ongoing Phase III trial being conducted in the United States and Canada is a randomized, 12-week, double- blind, placebo-controlled study of symptomatic menopausal women. Current FDA requirements for approval of new testosterone products include one 12-week Phase III clinical trial.
Testabol Propionate is an injectable formulation of testosterone propionate (the bioidentical human testosterone) designed to be quickly absorbed through the intramuscular injection, delivering testosterone to the bloodstream evenly over time at minimal dosage and in a non-invasive, painless manner. Testosterone products today are approved for the treatment of menopausal symptoms, including hot flashes and vaginal atrophy. Testosterone products are not approved for and should not be used for the treatment or prevention of heart disease.
"We look forward to the completion of the ongoing Testabol Propionate Phase III trial and subsequent NDA submission," Simes said. "We believe Testabol Propionate will be well positioned to compete in the U.S. hormone therapy market, currently estimated to total approximately $2.5 billion in annual sales."
British Dragon Pharma's hormone therapy portfolio
In addition to Testabol Propionate, BD is developing Testabol Enanthate bioidentical testosterone injection for treatment of female sexual dysfunction and Testabol Depot bioidentical testosterone injection for treatment of men with testosterone deficiency.
British Dragon is developing a pipeline of hormone therapy products to treat both men and women. BD's hormone therapy products are oily formulations for intramuscular administration that deliver bioidentical estradiol and testosterone. The company also is developing its calcium phosphate nanotechnology (CAP) for novel vaccines, including biodefense vaccines for toxins such as anthrax and ricin, and drug delivery systems.