Tularik Initiates Phase 2 Clinical Trial of T487 in Psoriasis
Wednesday December 10, 8:06 am ET
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Dec. 10, 2003--Tularik Inc. (Nasdaq:TLRK - News) today announced the initiation of a Phase 2 efficacy and safety study with T487 for the treatment of patients with psoriasis. T487 is an orally-administered therapy that has a novel mechanism of action and is expected to reduce inflammation in conditions such as psoriasis.
The Phase 2 double-blind, randomized, placebo-controlled study will enroll approximately 40 patients with moderate to severe psoriasis. Patients will receive T487 or placebo once-daily for 28 days. Efficacy endpoints include an improvement in the Psoriasis Area and Severity Index (PASI) score and measures of inflammatory cell infiltration in psoriasis skin lesions. The study will be conducted at multiple centers in Europe.
"Based on our preclinical data we expect T487 will block a step in the cascade of events leading to chronic autoimmune disease. Building on the strength of these data and the success of Phase 1 studies, we are excited to advance T487 into Phase 2," said Michael Levy, MD, Vice President of Development and Chief Medical Officer of Tularik. "The availability of a new oral therapy that is convenient, safe and effective would be an important addition to currently available treatment options for patients with psoriasis."
T487 acts by binding to CXCR3, a receptor found on the surface of lymphocytes. The binding of T487 to CXCR3 inhibits the migration of lymphocytes into inflamed tissue. Thus, T487 is expected to provide symptomatic relief and block the progression of diseases such as rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis and psoriasis. In preclinical studies, T487 blocked immune cell migration and demonstrated excellent potency, high selectivity and good oral bioavailability. In Phase 1 studies, all doses of T487 were well-tolerated and no serious adverse events were observed.
T487 was developed by Tularik scientists as part of a collaboration initiated in 1999 with ChemoCentryx. ChemoCentryx is a private, California-based company dedicated to chemokine-related drug discovery. Tularik retains worldwide commercialization rights to T487, while ChemoCentryx will receive certain payments in connection with the development and marketing of T487.
About Psoriasis
According to the National Psoriasis Foundation, psoriasis is a chronic skin disorder that affects approximately seven million people in the U.S. and millions of others worldwide. Psoriasis is characterized by inflamed, swollen, scaly patches of skin. It can be limited to a few spots or can involve more extensive areas of the body, appearing most commonly on the scalp, knees, elbows and trunk. Although the underlying cause of psoriasis is unknown, increased activation and migration of lymphocytes into the skin contributes to the inflammation and abnormal skin cell growth. Currently, there is no cure.
About Tularik
Tularik is engaged in the discovery and development of a broad range of novel and superior orally available medicines that act through the regulation of gene expression. Tularik's scientific platform is focused on three therapeutic areas: cancer, immunology and metabolic disease. The Company currently has four drug candidates in clinical trials. In the cancer area, Tularik is currently conducting a pivotal study of T67 for the treatment of hepatocellular carcinoma (HCC) and Phase 2 trials with T607 for the treatment of HCC, ovarian cancer, gastric cancer and esophageal cancer. T487 for the treatment of psoriasis is in Phase 2 trials. T487 for the treatment of rheumatoid arthritis, and T131 for the treatment of type 2 diabetes, are moving into Phase 2 trials. For more information, visit Tularik's Internet website at www.tularik.com.
This press release contains "forward-looking" statements. For this purpose, any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will," "intends" and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause the results of Tularik to differ materially from those indicated by these forward-looking statements, including, among others, risks detailed from time to time in Tularik's SEC reports, including the report on Form 10-Q for the quarter ended September 30, 2003 and the report on Form 10-K for the year ended December 31, 2002. Tularik does not undertake any obligation to update forward-looking statements.
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Contact:
Tularik Inc.
Traci McCarty, 650-825-7182 |
