Monday May 20, 6:01 am Eastern Time
Press Release
SOURCE: Tularik Inc.
Tularik Summarizes Research Data Presented at the 38th Annual Meeting of the American Society of Clinical Oncology
SOUTH SAN FRANCISCO, Calif.--(BW HealthWire)--May 20, 2002--Tularik Inc. (Nasdaq:TLRK - News) today provided an update for investors on the posters and abstracts published by the American Society of Clinical Oncology (ASCO) at its 38th Annual Meeting in Orlando, FL. Posters included data from three studies on the Company's lead anti-cancer drug, T67, and from two studies on its second-generation compound, T607.
Abstract #572
Phase 2 Study of T67 in Patients with Unresectable Hepatocellular Carcinoma (HCC)
This study investigated the activity of T67 in two patient groups: no prior chemotherapy (1st line) or one prior chemotherapy (2nd line). These HCC patients were treated with a dose of 165mg/m2, given by intravenous infusion every week, half the standard dose of 330mg/m2 given to other cancer patients. Of the evaluable 1st line patients, 9% (3/34) had partial responses (one confirmed and two unconfirmed) and an additional 38% (13/34) had stable disease. In addition, 19% (5/27) of evaluable patients had a greater than 50% reduction in alpha-fetoprotein (AFP), a tumor marker for HCC. Also of note was a partial response in the 2nd line arm of the study.
The most common adverse events considered to be related to T67 were infusion site pain (31%), fatigue (28%), nausea (25%) and diarrhea (11%). There were no grade 4 adverse events that were considered by the investigators to be related to T67. There was a low incidence (less than 5%) of grade 3 and no grade 4 hematologic toxicity. The low incidence of adverse events and hematologic toxicity, in combination with a pharmacokinetic analysis conducted in conjunction with the study, suggests that HCC patients may tolerate a significantly higher T67 dose than was administered in this study. Based on the results of this and other studies with T67, Tularik is currently conducting trials to further investigate the safety of T67 administered at higher doses and the effect of shortening the infusion time of the current dose. In addition, a Phase 1/2 combination study with T67 and doxorubicin is being initiated to study the effects of these two drugs together.
At the ASCO meeting, Thomas Leung, MD, lead investigator and Associate Professor at the Chinese University of Hong Kong, shared results from the Phase 2 study of T67 in patients with unresectable HCC. "The signs of anti-cancer activity with T67 in HCC patients, including objective partial responses and evidence of disease stabilization, are encouraging," stated Dr. Leung. "I am hopeful that additional clinical trials with T67 at higher doses will continue to be positive and provide greater evidence of efficacy against this terrible disease."
"Based on the results presented at this meeting, we are eager to move forward with T67 clinical development in HCC," said Dr. Michael Levy, VP of Development and Chief Medical Officer at Tularik. "We hope to have the opportunity to deliver a new treatment to a patient population that currently has no approved drugs available."
Abstract #416
Phase 1 Dose-Escalation Study with T607 Administered Weekly
This study was an open-label Phase 1 dose-escalation study that assessed the maximum tolerated dose (MTD), pharmacokinetics and safety of a 30-60 minute infusion of T607 administered weekly in cancer patients. The MTD was 100 mg/m2 weekly. The pharmacokinetics of T607 were linear with proportional increases in Cmax (maximum drug concentration achieved) and AUC ("Area Under the Curve" is a method of representing total drug exposure to the patient). The most common adverse events that were considered to be related to T607 were nausea, vomiting, fatigue and diarrhea. There were no grade 4 adverse events.
Abstract #417
Phase 1 Dose-Escalation Study with T607 Administered Every 3 Weeks
This study is an open-label Phase 1 dose-escalation study to assess
the MTD, pharmacokinetics and safety of a 30-60 minute infusion of T607 administered daily for 5 days every 3 weeks in cancer patients. The MTD has not yet been determined. The pharmacokinetics of T607 were linear with proportional increases in Cmax and AUC. The most common adverse events that were considered to be related to T607 were fatigue, diarrhea, nausea and weakness. There were no grade 4 adverse events.
Other Posters Presented by Tularik at ASCO:
Abstract #415: A Phase 1 Dose-Escalation Study of the Anti-Microtubule Agent T67-Sodium Administered Daily for 5 Days Every 3 Weeks. The MTD was 175mg/m2, and the pharmacokinetics of T67 were linear with proportional increases in Cmax and AUC.
Abstract #1282: A Phase 2 Study of T67-Sodium in Prior Taxane Treated Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC). Patients were administered a 330mg/m2 dose of T67 over 3 hours every week. The data showed no efficacy in patients with NSCLC.
About T67 and T607
Tularik's lead drug candidate, T67, has a novel chemical structure that binds irreversibly to B-tubulin, which distinguishes it from other tubulin-binding agents. B-tubulin is a cellular building block of microtubules and is essential to cell division. With over 260 patients dosed to date, T67 has shown objective partial responses (greater than 50% reduction in tumor size) in treating patients with HCC and an acceptable toxicity profile. Tularik's second anti-tubulin agent, T607, is an analog of T67, but differs from T67 in that it does not cross the blood brain barrier and has a different tissue distribution profile. Tularik observed a partial response in HCC with this drug candidate as well, suggesting that the mechanism of action shared by T67 and T607 may have particular utility for the treatment of this aggressive form of cancer. T67 and T607 were discovered and are being developed by Tularik.
About Hepatocellular Carcinoma
HCC is a tumor type that is on the rise in the United States, principally in relation to increases in Hepatitis C infection rates. Worldwide, there are over 1 million new cases of HCC annually and it is the 3rd most common cause of cancer death. In the US, it is estimated that more than 20,000 people will be diagnosed with HCC annually. HCC is an aggressive malignancy: the six month survival rate from time of diagnosis is 50%, the one year survival rate is 24% and the five year survival rate is less than 5%. There are currently no approved systemic chemotherapies for HCC.
About Tularik
Tularik is engaged in the discovery and development of a broad range of novel and superior orally available medicines that act through the regulation of gene expression. Tularik's scientific platform spans seven disease-based programs focused on three areas: cancer, immunology and metabolic disease. For more information, visit Tularik's Internet website at www.tularik.com.
This press release contains "forward-looking" statements. For this purpose, any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will," "intends" and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause the results of Tularik to differ materially from those indicated by these forward-looking statements, including, among others, risks detailed from time to time in Tularik's SEC reports, including the report on Form 10-Q for the quarter ended March 31, 2002.
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Contact:
Tularik Inc.
Traci McCarty, 650/825-7182 |
