- Phase II Study for Urinary Tract Infection Vaccine and Phase I Study for Vitaxin™ -
Gaithersburg, MD, March 13, 2001 -- MedImmune, Inc. (Nasdaq: MEDI) announced today that it had initiated new trials for two important product candidates in clinical development: the company's vaccine candidate to prevent urinary tract infections (UTI) and VitaxinTM, an antibody candidate that targets a specific integrin (avb3) with broad clinical implications in areas such as cancer, rheumatoid arthritis and restenosis.
“We believe that 2001 will be an exciting time for the advancement of our development pipeline,” said Dr. James F. Young, MedImmune's president, research and development. “We have an enormous amount of clinical activity underway, and anticipate expanding our efforts into a number of new trials throughout the year.”
Vaccine to Prevent Urinary Tract Infections A second Phase II study has been initiated for MedImmune's vaccine candidate to prevent urinary tract infections (UTI) caused by Escherichia coli (E. coli). The study is a randomized, double-blind, controlled vaccine study designed to evaluate the safety and efficacy of the vaccine candidate. The study will enroll 300 women with no recent history of recurrent UTIs who will receive three intramuscular injections of the vaccine plus an adjuvant (MF59C.1), or just the adjuvant. Dosing will occur on days 0, 28, and 180 of the study.
In December 2000, MedImmune began an initial Phase II study evaluating the safety and efficacy of the vaccine in 90 women with recurrent urinary tract infections. Patients are continuing to be enrolled in the first study and initial results from both Phase II studies are expected to be available later this year.
Currently, there are no vaccines available to prevent UTIs, one of the most common medical conditions that affect women. It has been estimated that 40 percent of all women in the U.S. experience at least one UTI during their lifetime, and more than 20 percent experience recurrent infection. Further, estimates indicate that the disease results in approximately seven million office visits each year, with an estimated annual health care cost exceeding $1 billion.
E. coli are naturally occurring bacteria, found in the gastrointestinal tract, that cause more than 80 percent of all UTIs. For an E. coli UTI to occur, bacteria spread to the urogenital mucosa, ascend into the bladder, and adhere to bladder cells, where they multiply and establish an infection. Preclinical data with MedImmune's vaccine candidate indicate that it induces antibodies that block E. coli from attaching to bladder cells. Data from a Phase I safety study with this vaccine candidate was presented on March 10, 2001 at the International Bladder Symposium in Washington, D.C.
A Phase I pharmacokinetic study has been initiated with VitaxinTM. This non-randomized, open-label, dose-escalating study will be conducted in 24 patients with refractory solid tumors. The objectives of the study are to determine the safety and pharmcokinetics of single and multiple doses of Vitaxin when administered intravenously. Further, the study will determine the Phase II dose and schedule for Vitaxin, and observe any evidence of anti-tumor activity. Vitaxin will be administered intravenously at up to six dose levels.
Vitaxin is a humanized monoclonal antibody that may have broad clinical applicability, including the potential to inhibit angiogenesis (the growth of new blood vessels) by binding to avb3, an integrin expressed by endothelial cells and critical to new blood vessel growth. Angiogenesis is critical in the development of several diseases, including rheumatoid arthritis and psoriasis. In addition, angiogenesis is required for the growth and metastasis of malignancies.
MedImmune licensed Vitaxin from Applied Molecular Evolution, Inc. (Nasdaq: AMEV) in February 1999. During 2000, the two companies worked together to prepare a more potent version of the original Vitaxin molecule using AME's proprietary technology.
MedImmune, Inc. is a biotechnology company focused on developing and marketing products that address medical needs in areas such as infectious disease, immune regulation and cancer. Headquartered in Gaithersburg, Maryland, MedImmune has manufacturing facilities in Frederick, Maryland and Nijmegen, the Netherlands.
This announcement may contain, in addition to historical information, certain forward-looking statements that involve risks and uncertainties. Such statements reflect management's current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, including risks and uncertainties discussed in the company's filings with the U.S. Securities and Exchange Commission. The company is developing several products for potential future marketing. There can be no assurance that such development efforts will succeed, that such products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success.