Exelixis, Inc. (EXEL), a small molecule therapeutics company, Monday said the U.S. Food & Drug Administration has granted orphan drug designation to its XL184 for treatment of follicular, medullary, and anaplastic thyroid carcinoma and metastatic or locally advanced papillary thyroid cancer.
Further, the United States Adopted Name Council and the World Health Organization's INN programme have adopted cabozantinib as the generic name for XL184.
South San Francisco, California-based company, which develops small molecule drugs for the treatment of cancer, metabolic, and cardiovascular disorders, stated that a pivotal phase 3 trial of XL184 is ongoing in patients with medullary thyroid cancer, the top-line results of which are expected in the first-half of 2011. Exelixis intends to file a New Drug Application for the compound in the second-half of 2011.
In addition, Exelixis is evaluating XL184 in phase 2 in solid tumors including metastatic castration-resistant prostate cancer, ovarian cancer, melanoma, breast cancer, non-small cell lung cancer, and hepatocellular cancer and in a phase 1 trial in renal cell carcinoma and differentiated thyroid cancer. A phase 2 trial in recurrent glioblastoma is ongoing, the company added.
Michael Morrissey, president and chief executive officer of the company said, "We intend to leverage the benefits associated with orphan drug status to support our aggressive development of XL184 in a broad number of cancers. We believe this will help position us towards achieving our goals of improving outcomes for patients in some of the largest cancer indications while realizing the commercial potential of this first-in-class dual MET/VEGFR inhibitor."
MET and VEGFR2 are key kinases, or a type of enzyme that transfers phosphate groups from high-energy donor molecules, involved in the development and progression of many cancers.
EXEL closed Friday's regular trading at $8 on the Nasdaq.
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