PALO ALTO, Calif., Jan. 11, 2013 /PRNewswire/ -- Telik, Inc. (Nasdaq: TELK) was notified today that its product candidate, ezatiostat HCL (Telintra), has been granted orphan drug designation by the US Food and Drug Administration (FDA) for the treatment of myelodysplastic syndrome (MDS). Orphan designation grants potential US market exclusivity to a drug for the treatment of a specified condition for a period of seven years following FDA marketing approval. Additional potential benefits of orphan designation include development grants, tax credits related to clinical trial expenses, protocol development assistance and exemption from FDA user fees. The US Orphan Drug Act aims to encourage the development of drugs for the diagnosis, prevention and treatment of medical conditions affecting fewer than 200,000 people in the US.
Telintra is an investigational agent in development for the treatment of MDS and idiopathic chronic neutropenia. Telintra is a novel inhibitor of the enzyme glutathione S-transferase P1‑1, leading to activation of Jun kinase, a key regulator of cellular growth and differentiation of blood precursor cells. Telintra has been shown to cause clinically significant and sustained reduction in red blood cell transfusions, transfusion independence and multilineage responses in MDS patients. The results of four clinical trials of Telintra in MDS have been reported in peer-reviewed scientific journals.
Telik is a clinical stage drug development company focused on discovering and developing small molecule drugs to treat cancer. Telik's product candidates were discovered using its proprietary drug discovery technology, TRAP®, which enables the rapid and efficient discovery of small molecule drug candidates. Additional information is available at www.telik.com.
Notice Concerning Forward-Looking Statements:This press release contains or implies "forward-looking" statements regarding the safety and effectiveness of Telintra in treating MDS, the qualification for and period of market exclusivity and other benefits associated with the orphan designation of Telintra for the treatment of MDS and Telintra's potential method of action and capability to cause clinically significant and sustained reduction in red blood cell transfusions, transfusion independence and multilineage responses in MDS patients. These forward-looking statements are based upon Telik's current expectations, and there are important factors that could cause actual results to differ materially from those indicated by these forward-looking statements. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in Telik's periodic filings with the Securities and Exchange Commission, including the factors described in the section entitled "Risk Factors" in its quarterly report on Form 10-Q for the quarter ending September 30, 2012. Telik does not undertake any obligation to update forward-looking statements contained in this press release. Telik, the Telik logo, TELINTRA and TRAP are trademarks or registered trademarks of Telik, Inc.
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