The Medicines Company and NIH Start Clinical Trial of CTV-05, a Natural Probiotic for Bacterial Vaginosis and Urogenital Diseases.

Health/Medical Writers

CAMBRIDGE, Mass.--(BW HealthWire)--Sept. 6, 2000

The Medicines Company (Nasdaq: MDCO) announced today that it has started a large, randomized clinical trial of its probiotic CTV-05 as an adjunct to standard antibiotic treatment of bacterial vaginosis (BV). The trial is funded by National Institutes of Health, National Institute of Allergy and Infectious Disease (NIH, NIAID) and jointly managed by The Medicines Company and NIH, NIAID.

Bacterial vaginosis is one of the most common vaginal diseases in women of reproductive age with an estimated prevalence of more than 10% of women in the United States. BV is associated with several serious health risks including pelvic inflammatory disease, miscarriage, pre-term birth and post surgical infection. Studies have also shown a correlation between BV and increased susceptibility to sexually transmitted infections, including HIV.

Current treatment for BV consists of orally or vaginally administered antibiotics, including metronidazole and clindamycin. Studies have shown that these antibiotics have poor 30-day cure rates with high recurrence rates. Treatment failure and recurrence are believed to result from failure to restore naturally occurring Lactobacillus which are depleted by BV. The trial will test whether replacement of Lactobacillus in the form of CTV-05 improves the 30-day cure rates and reduces the rate of recurrence at 90 days for BV. Preliminary studies including in vitro and in vivo work with the new agent have shown such an effect and the trial is designed to confirm this activity.

CTV-05 is a strain of Lactobacillus called Lactobacillus crispatus, a naturally occurring bacterium believed to be a key component of human vaginal health. The presence of Lactobacillus in the vagina, particularly those strains that produce hydrogen peroxide is associated with a reduced incidence of BV and other urogenital diseases such as Urinary Tract Infection. Lactobacillus crispatus is the dominant strain of Lactobacillus in the urogenital tract.

Dr. Penelope Hitchcock, Director of the Sexually Transmitted Disease Branch of NIAID, said "This product development effort is a key part of our topical microbicides program. We anticipate that CTV-05 will help maintain vaginal defense mechanisms and reduce women's risk for sexually transmitted infections (STI)." The NIAID conducts and sponsors research in infectious diseases that affect public health, with a strong interest in preventive measures. The topical microbicide program focuses on the development of products that interfere with STI pathogens by killing them upon entry to the body or by creating a barrier to the pathogen, blocking its ability to enter or bind with cells.

"We believe that a natural probiotic treatment that is effective and easy to use will change the management of BV and improve the lives of many women. We are impressed by the NIH program to date and believe that our collaboration will move the field and science forward in a demonstrative fashion," said Clive Meanwell M.D., Ph.D., President and CEO of The Medicines Company.

With a planned enrollment target of 350 women, this is the first large-scale clinical trial of Lactobacillus in BV and one of the first to address the key medical challenge of frequent disease recurrence. A typical shortcoming of trials in treating BV is their failure to look beyond 30 days endpoints and address the more fundamental issue of recurrence. Consequently, the study will look at cure rates at 30 days, but will also evaluate patients at 90 days for recurrence of BV. In the study, CTV-05 will be administered in conjunction with the antibiotic metronidazole. The trial is led by Drs. Sharon Hillier, Pamela Murray and Jeanne Marrazzo at, respectively, Magee Women's Hospital, Children's Hospital of Pittsburgh and University of Washington in Seattle. "This study will help us define the role of Lactobacillus replacement in the treatment and prevention of disease," commented Dr. Hillier.

Based in Cambridge, Massachusetts, The Medicines Company acquires, develops and commercializes biopharmaceutical products in late stages of development. The Company's lead product, Angiomax(TM), directly blocks or inhibits the actions of thrombin, a key component in the formation and growth of blood clots. In May 2000, the Company received an approvable letter from the U.S. Food and Drug Administration for the use of Angiomax in the treatment of patients with unstable angina undergoing angioplasty.

This press release contains forward-looking statements that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words, "believes," "anticipates," "plans," "expects," "intends," and similar expressions are intended to identify forward-looking statements. Important factors that could cause actual results to differ materially from the expectations described in these forward-looking statements are set forth under the caption "Risk Factors" in the Company's Registration Statement on Form S-1 which is on file with the Securities and Exchange Commission and incorporated herein by reference. These risk factors include risks as to whether the Company's products will advance in the clinical trials process, the timing of such clinical trials, whether the results obtained in preliminary studies will be indicative of results obtained in clinical trials, whether the clinical trial results will warrant continued product development, whether and when, if at all, the Company's products, including Angiomax, will receive approval from the U.S. Food and Drug Administration or equivalent regulatory agencies, and for which indications, and, if such products receive approval, whether they will be successfully marketed; the Company's history of net losses and how long the Company will be able to operate on its existing capital resources; and the Company's dependence on third parties, including manufacturers and suppliers.