Telik Announces Preliminary Agreement On Design Of Phase 3 Registration Trial
Of Telintra® In Low To Intermediate-1 Risk Myelodysplastic Syndrome
PALO ALTO, Calif., Jan. 22, 2013
PALO ALTO, Calif., Jan. 22, 2013 /PRNewswire/ --Telik, Inc. (Nasdaq: TELK)
announced the completion of an End of Phase 2 meeting with the US Food and
Drug Administration (FDA). Preliminary agreement was reached regarding the
design of a Phase 3 placebo-controlled randomized registration trial of
Telintra (ezatiostat) for the treatment of Low to Intermediate-1 risk
myelodysplastic syndrome (MDS), using red-blood-cell transfusion independence
as the endpoint. In accordance with the FDA's guidance, Telik plans to
complete the design of the Phase 3 registration trial. In order to focus its
resources on the registration program, Telik has decided to stop further
enrollment in its ongoing Phase 2 exploratory trials.
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.
Telintra has been granted orphan drug designation by the 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.
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
Telik's ability to complete the design of and initiate a Phase 3 randomized
registration trial of Telintra for the treatment of MDS, to undertake such a
trial and to secure adequate financing, Telintra's safety and effectiveness in
treating MDS and idiopathic chronic neutropenia, Telintra's capability to
cause clinically significant and sustained reduction in red blood cell
transfusions, transfusion independence and multilineage responses and the
qualification for and period of market exclusivity associated with orphan drug
designation of Telintra. 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.,
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