Press Release Source: Telik, Inc.
Telik Announces 46% Objective Response Rate in Phase 2 Trial of Telcyta(TM) in Combination With Liposomal Doxorubicin in Platinum Refractory or Resistant Ovarian Cancer Saturday June 5, 9:05 am ET
PALO ALTO, Calif., June 5 /PRNewswire-FirstCall/ -- Telik, Inc. (Nasdaq: TELK - News) reported positive results from a Phase 2 clinical trial using the combination of TELCYTA(TM) (TLK286) and liposomal doxorubicin. The combination demonstrated a 46% objective response rate by RECIST, and a 77% disease control rate, in patients with platinum refractory or resistant ovarian cancer. The results were presented today at the 40th annual meeting of the American Society of Clinical Oncology in New Orleans.
Twenty-one patients have been enrolled in the Phase 2 portion of the trial. All of the patients were refractory or resistant to platinum-based chemotherapy. Thirteen patients were evaluable for efficacy; eight patients were too early to evaluate.
"The results of this trial demonstrate that the combination of TELCYTA(TM) and liposomal doxorubicin has the potential for improving the outcome of anthracycline-based regimens, and confirm the single agent activity of TELCYTA(TM) observed in previous Phase 2 clinical trials," said Gail L. Brown, M.D., senior vice president and chief medical officer. Single agent liposomal doxorubicin has demonstrated a 12.6% objective response rate in patients with platinum refractory or resistant ovarian cancer in the evidence-based medical literature.(1) "The enhanced efficacy seen with the TELCYTA(TM)-liposomal doxorubicin combination in this trial was not associated with new or unanticipated toxicities."
About Ovarian Cancer and TELCYTA(TM)
Approximately 25,580 new cases of ovarian cancer will be diagnosed in 2004, according to the American Cancer Society. Ovarian cancer causes more deaths than any other cancer of the female reproductive system.
TELCYTA is currently in Phase 3 registration trials in ovarian and non-small cell lung cancer (NSCLC), and it has been successfully tested in Phase 2 trials in ovarian, NSCLC, breast and colorectal cancer. This small molecule drug is activated by GST P1-1, an enzyme present in cancer cells. Upon activation, an intracellular process known as apoptosis, or programmed cell death, occurs. TELCYTA was discovered through the application of Telik's proprietary drug discovery technology, TRAP.
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Press Release Source: Telik, Inc.
Telik Announces 56% Objective Response Rate of Telcyta(TM) in Combination With Carboplatin in Phase 2 Study in Platinum Refractory or Resistant Ovarian Cancer Saturday June 5, 9:05 am ET
PALO ALTO, Calif., June 5 /PRNewswire-FirstCall/ -- Telik, Inc. (Nasdaq: TELK - News) reported positive results from a Phase 2 clinical trial using the combination of TELCYTA(TM) (TLK286) and carboplatin. The combination demonstrated a 56% objective response rate by RECIST in patients with platinum refractory or resistant ovarian cancer, including 3 patients with complete responses. The overall disease control rate was 88%. The results were presented at the 40th annual meeting of the American Society of Clinical Oncology today in New Orleans.
Twenty-one patients were enrolled in the Phase 2 trial. Sixteen patients were evaluable for efficacy; five patients were too early to evaluate.
"The high objective response rate seen in this platinum refractory-resistant patient group suggests that TELCYTA(TM) has the potential to re-sensitize platinum refractory or resistant ovarian cancer to platinum, and confirms the single agent activity of TELCYTA(TM) observed in previous Phase 2 studies without new or unanticipated toxicities," said Gail L. Brown, M.D., senior vice president and chief medical officer. In the evidence-based medical literature, response rates to platinum as well as other second line agents of approximately 10% have been reported in ovarian cancer patients with platinum refractory or resistant disease.(1,2,3)
"This trial provides a strong foundation for a randomized Phase 3 trial, which we plan to initiate later this year," said Dr. Brown. "These data also support the further evaluation of the TELCYTA-carboplatin combination in first-line non-small cell lung and other cancers treated with platinum-based chemotherapy."
Telik plans to initiate a multicenter Phase 3 randomized trial of approximately 200 patients with second-line platinum refractory or resistant ovarian cancer. The patients will be randomized to receive either the combination of TELCYTA plus carboplatin or a single agent currently approved for the treatment of ovarian cancer in the second line. This trial is in addition to the ongoing Phase 3 trials evaluating TELCYTA as a single agent in platinum-resistant ovarian and non-small cell lung cancer.
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Press Release Source: Telik, Inc.
Telik Announces 27% Objective Response Rate in Phase 2 Trial Of Telcyta(TM) in Combination With Docetaxel in Platinum-Resistant Non-Small Cell Lung Cancer Saturday June 5, 9:05 am ET
PALO ALTO, Calif., June 5 /PRNewswire-FirstCall/ -- Telik, Inc. (Nasdaq: TELK - News) reported positive results from a Phase 2 clinical trial using the combination of TELCYTA(TM) (TLK286) and docetaxel in patients with platinum-resistant non-small cell lung cancer (NSCLC). The combination demonstrated a 27% objective response rate by RECIST with one complete response and seven partial responses. The overall disease control rate was 67%. The results were presented today at the 40th annual meeting of the American Society of Clinical Oncology in New Orleans.
Thirty-seven patients were enrolled and thirty patients were evaluable for efficacy. All of the patients had failed or progressed on prior platinum-based chemotherapy. One-third of the patients had failed treatment with EGFR inhibitors.
"The results of this trial, demonstrating a 27% objective response rate, are significant given that the objective response rate reported in the evidence-based medical literature with docetaxel as a single agent in the second line setting in platinum-resistant non-small cell lung cancer is 5 to 9%1,2,3, and confirm the single agent activity of TELCYTA(TM)," said Gail L. Brown, M.D., senior vice president and chief medical officer. "These data demonstrate that the combination of TELCYTA(TM) and docetaxel may provide significant clinical benefit with durable responses without new or unanticipated toxicities. In addition, these results support additional clinical trials using the TELCYTA(TM)/docetaxel combination in the first and second line non-small cell lung cancer treatment."
About Non-Small Cell Lung Cancer and TELCYTA(TM)
Lung cancer is the leading cause of cancer deaths, according to the American Cancer Society (ACS). The ACS estimates that 173,770 new cases of lung cancer will be diagnosed in 2004 and an estimated 160,440 deaths will result from the disease. |
