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Combination and Highly Statistically Significant Effect of TELCYTA as Maintenance Therapy in First-Line Non-Small Cell Lung Cancer

http://www.prnewswire.com/cgi-bin/stori ... 863&EDATE=

PALO ALTO, Calif., April 17 /PRNewswire-FirstCall/ -- Telik, Inc.

(Nasdaq: TELK) announced the presentation today of results from a Phase 2

clinical trial of the triplet combination of TELCYTA® (canfosfamide HCl,

TLK286), carboplatin and paclitaxel in the first-line treatment of advanced

non-small cell lung cancer. The results include highly statistically and

clinically significant improvement in both progression-free survival and

overall survival in responding patients who received TELCYTA maintenance

therapy as compared with those who did not receive TELCYTA maintenance

therapy. The data were presented at the 98th annual meeting of the American

Association for Cancer Research (AACR) in Los Angeles.

The multicenter dose-ranging study enrolled 129 patients with Stage

IIIB or IV non-small cell lung cancer. Patients received standard doses of

carboplatin and paclitaxel and one of four doses of TELCYTA (400, 500, 750

or 1,000 mg/m2) for a planned course of four to six cycles. Patients with

objective responses or stable disease following completion of combination

therapy could elect to receive every three week maintenance cycles of

TELCYTA as monotherapy until disease progression. Outcomes to be evaluated

included safety, objective response and disease stabilization rates,

progression-free survival and overall survival in the intent-to-treat

population, and safety, progression-free survival and overall survival in

patients receiving TELCYTA maintenance therapy.

In the intent-to-treat population (n = 129), the overall objective

response rate was 34% (95% CI 26%, 43%), including one complete response.

Fifty-six patients, or 43%, had disease stabilization, for an overall

disease stabilization rate of 77% (95% CI 69%, 84%). Median

progression-free survival was 4.9 months, and the overall median survival

was 9.6 months.

One hundred patients (77% of enrolled patients) had objective responses

or stable disease at the completion of combination therapy. Fifty of these

patients received TELCYTA maintenance therapy and 50 did not receive

maintenance therapy. Median progression-free survival for patients on

TELCYTA maintenance therapy was 6.9 months, compared with 4.2 months for

those who did not receive TELCYTA maintenance therapy (p< 0.0001, HR 0.36).

Overall median survival for the TELCYTA-treated patients was 14.2 months

compared with 8.4 months without TELCYTA maintenance therapy (p= 0.0003, HR


The triplet combination was generally well-tolerated at all TELCYTA

doses evaluated, with toxicities similar to those expected with each drug

alone. There were no new, unexpected or cumulative toxicities. TELCYTA

maintenance therapy was, as expected, well-tolerated, with Grade 1 or 2

toxicities observed in fewer than 5% of patients.

"Many approaches to maintenance therapy following first-line treatment

for advanced non-small cell lung and ovarian cancer have been evaluated,

with most adding little to efficacy while exposing patients to ongoing

risks from toxic chemotherapy," said Gail L. Brown, M.D., senior vice

president and chief medical officer. "The safety profile and clinical

activity of TELCYTA, both in combination with carboplatin and paclitaxel

and as monotherapy, suggest a potential role for this investigational agent

as part of first-line combination treatment and as single agent maintenance

therapy of non-small cell lung cancer. We will review these results with

our expert advisors to discuss plans to expeditiously advance the TELCYTA

program toward registration."

Telik, Inc. of Palo Alto, CA is a biopharmaceutical company focused on

discovering, developing and commercializing novel small molecule drugs to

treat serious diseases. The company's most advanced drug development

candidate is TELCYTA, a tumor-activated small molecule product candidate in

clinical development for the treatment of advanced ovarian cancer and

non-small cell lung cancer. A second drug development candidate,

TELINTRA (TLK199), is in clinical development for myelodysplastic

syndrome. 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 http://www.telik.com.

This press release contains "forward-looking" statements, including

statements regarding the potential for TELCYTA to treat one or more types

of cancer. There are important factors that could cause Telik's results to

differ materially from those indicated by these forward-looking statements,

including, among others, that none of Telik's product candidates have been

determined to be safe or effective in humans or been approved for

marketing, clinical trials of Telik's product candidates may take several

years to complete and may not be successful, success in preclinical testing

and early clinical trials does not ensure that later clinical trials will

be successful and interim results of clinical trials do not necessarily

predict final results. 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 annual

report on Form 10-K for the year ended December 31, 2006. Telik does not

undertake any obligation to update forward-looking statements contained in

this press release.

TELIK, the Telik logo, TELCYTA, TELINTRA and TRAP are trademarks or

registered trademarks of Telik, Inc.

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