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FDA Grants Orphan Drug Designation for Troxatyl (Troxacitabine)
SAN DIEGO, CA -- May 12, 2005 -- Structural GenomiX, Inc. (SGX) announced today that it has been granted Orphan Drug Designation from the U.S. Food and Drug Administration for its lead product candidate, Troxatyl™ (troxacitabine), for the treatment of acute myelogenous leukemia (AML).
Troxatyl is a novel nucleoside analog that is currently being evaluated by the Company in a Phase 1/2 trial for the treatment of relapsed AML and in a Phase 1/2 trial for the treatment of various solid tumors. The Company plans to complete the Phase 1/2 AML trial and progress Troxatyl into a Phase 2 trial in relapsed and/or refractory adult AML patients in mid 2005.
Preliminary data from the Company's Phase 1/2 AML trial will be presented in a poster session at the American Society of Clinical Oncology (ASCO) 2005 Annual Meeting in Orlando, Florida.
Orphan Drug Designation provides the sponsor of an orphan drug product with eligibility for: seven year marketing exclusivity following marketing approval; tax credits for clinical research; reduced NDA filing fees; grants for further clinical research and development; and assistance with the review of clinical trials protocols.
About Troxatyl
Troxatyl is an anti-cancer agent currently in Phase 1/2 acute myelogenous leukemia (AML) clinical trials. SGX plans to complete the ongoing Phase 1/2 studies and progress Troxatyl into Phase 2 in mid 2005. Over 600 patients have received Troxatyl in various Phase 1 and 2 studies where delivery of the drug was by bolus intravenous (IV) administration. Preclinical studies have shown that continuous IV infusion results in a significant increase in exposure of cancer cells to Troxatyl. Evaluation of Troxatyl administered by continuous IV infusion in patients is currently ongoing in clinical studies.
About AML
AML is a hematopoietic stem cell disorder that is the most common form of leukemia, accounting for approximately 90 percent of all acute leukemias in adults. Although induction chemotherapy results in complete remission in 50-75 percent of patients, relapse is very common and long-term survival rates remain at less than 20 percent. Unfortunately, patients with relapsed AML at present have very limited treatment options pointing out the need for the development of new agents in this area.
SOURCE: Structural GenomiX, Inc.
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