MedImmune to Study Therapeutic Benefit of Vitaxin(R) To Treat Prostate Cancer and Psoriasis
Wednesday, December 17, 2003 08:30 AM ET Printer-friendly version
Two New Phase 2 Studies Expand Efforts in Both Oncology and Immunology for Vitaxin
GAITHERSBURG, Md., Dec. 17 /PRNewswire-FirstCall/ -- MedImmune, Inc. (Nasdaq: MEDI, news) announced today the initiation of two additional Phase 2 clinical trials for Vitaxin, a development-stage monoclonal antibody. In one trial, MedImmune will evaluate the anti-tumor activity and safety of Vitaxin in patients with prostate cancer that has metastasized to bone. In the second trial, MedImmune will evaluate the activity of Vitaxin on psoriasis. In September, MedImmune announced the initiation of the first two Phase 2 trials with Vitaxin, involving patients with melanoma and rheumatoid arthritis (RA).
"We believe, based on preclinical models, that Vitaxin's novel mechanism of action may be applicable to the treatment of many types of cancer and inflammatory disease," said Dr. Edward M. Connor, MedImmune's senior vice president, clinical development. "Safety and pharmacokinetic data obtained in Phase 1 studies have been encouraging, and we are pleased to expand the comprehensive clinical development program for the antibody. We also look forward to having our first Phase 2 safety and efficacy data in the second half of 2004."
Vitaxin targets the alpha-v beta-3 integrin, which is a protein complex expressed on the surface of newly forming blood vessels, certain tumor types, and on a number of other cell types, including macrophages and osteoclasts. As such, alpha-v beta-3 integrin is implicated in a number of disease processes, including the growth and metastasis of tumors, the bone destruction in RA and the inflammatory process in psoriasis.
Phase 2 Prostate Cancer Trial
MedImmune's Phase 2 prostate cancer trial is a randomized, open label, three-arm study involving approximately 165 patients with androgen-independent prostate cancer that has metastasized to bone. The trial, conducted at approximately 50 sites, will examine the safety and anti-tumor activity of Vitaxin in combination with chemotherapy. In the study, patients will receive weekly intravenous infusions of Vitaxin at a dose of 8.0 mg/kg in combination with weekly docetaxel (one with estramustine and one without). The third arm involves chemotherapy, docetaxel and estramustine without Vitaxin.
According to the American Cancer Society (ACS), prostate cancer is the second most common type of cancer found in American men, trailing only skin cancer incidence. In 2003, ACS estimates that there will be about 220,900 new cases of prostate cancer in the U.S. and approximately 28,900 deaths due to the disease. It is believed that one out of every six men will get prostate cancer during his lifetime. Although most prostate cancers grow very slowly, the prognosis is very poor in cases where the disease has spread to bone or other organs.
Phase 2 Psoriasis Trial
MedImmune's Phase 2 psoriasis trial is a randomized, two-part, double- blind, placebo-controlled study of approximately 180 patients with plaque psoriasis involving at least 10 percent of body surface area and with a minimum PASI (Psoriasis Area and Severity Index) score of 12. This study, which will be conducted at about 30 sites, is designed to evaluate the safety and activity of Vitaxin, administered subcutaneously for 12 weeks, compared to placebo.
According to the National Psoriasis Foundation, psoriasis is a common chronic skin disease affecting 2.1 percent of the U.S. population (more than 4.5 million American men, women and children). Psoriasis occurs when faulty signals in the immune system cause skin cells to regenerate too quickly leading to the forming of red, flaky, scaly patches (called plaques) that can itch, crack, and bleed as well as be extremely painful. Psoriasis generally appears on the joints, limbs and scalp but it can appear anywhere on the body, covering some people from head to toe.
About MedImmune, Inc.
MedImmune is a leading biotechnology company focused on researching, developing and commercializing products to prevent or treat infectious disease, autoimmune disease and cancer. MedImmune actively markets four products, Synagis® (palivizumab), FluMist™ (influenza virus vaccine live, intranasal), Ethyol® (amifostine) and CytoGam® (cytomegalovirus immune globulin intravenous (human)), and has additional products in clinical testing. MedImmune employs approximately 1,700 people, is headquartered in Gaithersburg, Maryland, and has additional operations in Frederick, Maryland, as well as Pennsylvania, California, the United Kingdom and the Netherlands. For more information on the company, visit MedImmune's website at medimmune.com.
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 MedImmune'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.
Source: MedImmune, Inc.
Contact: Media: Jamie Lacey, +1-240-632-4035; or Investors: Will Roberts, +1-240-632-4358, or John Filler, +1-240-632-4086, all of MedImmune, Inc.
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