Telik Announces Orphan Designation Of Telintra® For Treatment Of
PALO ALTO, Calif., Jan. 11, 2013
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
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
Telik, the Telik logo, TELINTRA and TRAP are trademarks or registered
trademarks of Telik, Inc.
SOURCE Telik, Inc.
Contact: Denise San Bartolome, Corporate Communications, Telik, Inc., +1-650
845 7712, firstname.lastname@example.org
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