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Wednesday, May 21, 2008

Press release about interim results on a clinical trial involving 2 ACC patients

Genentech Provides Update On Studies Of Investigational Biooncology Agents To Be Presented At The American Society Of Clinical Oncology Meeting

South San Francisco, Calif. -- May 15, 2008 -- Genentech, Inc. (NYSE:DNA) today announced results from studies of several investigational agents targeting the biological cancer pathways of HER (human epidermal growth factor receptor) signaling, Hedgehog signaling and apoptosis (programmed cell death). These data will be presented during the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) taking place May 30 to June 3 in Chicago. Results will be presented from a Phase II study of pertuzumab in HER2-positive metastatic breast cancer and Phase I studies of trastuzumab-DM1 (T-DM1), an investigational HER2 antibody-drug conjugate; GDC-0449, a small molecule antagonist of the Hedgehog pathway [bold type by th]; and two novel agents designed to trigger apoptosis, ABT-263 and Apo2L/TRAIL.

"Early clinical data with these investigational anti-cancer agents reflects our significant research effort and demonstrates Genentech's commitment to discovering the next cancer breakthroughs," said Susan Desmond-Hellmann, M.D., M.P.H., president, Product Development. "By exploring new cellular targets and cancer growth pathways, we hope this research may ultimately lead to improved treatment options for people with cancer."

A First-in-Human, First-in-Class, Phase I Study of Systemic Hedgehog Pathway Antagonist, GDC- 0449, in Patients with Advanced Solid Tumors (Abstract #3516)
Patricia LoRusso, D.O., Karmanos Cancer Center, Wayne State University, Detroit, Mich.; Oral Presentation; Sunday, June 1, 2008, 8:00 a.m. - 8:15 a.m. CDT; W375a

Interim results will be presented from a Phase I study evaluating the safety, tolerability and pharmacokinetic profile of GDC-0449, a small molecule antagonist of the Hedgehog signaling pathway, in 19 patients with refractory solid tumors that have not responded to prior treatment. GDC-0449 demonstrated a favorable pharmacokinetic profile, with high sustained micromolar plasma concentrations and a terminal half-life of greater than seven days. No dose-limiting adverse events were observed at the three dose levels of GDC-0449 studied.

Two cases of reversible drug-related Grade 3 hyponatremia (lowered serum sodium level) and one case of reversible Grade 3 drug-related fatigue were reported. Stable disease was achieved in two patients with adenocystic carcinoma (a rare cancer most commonly found in the salivary glands) and partial responses were observed during this study in two patients with advanced basal cell carcinoma (BCC).

Data were reported earlier this year (American Association for Cancer Research, April 2008) for nine patients with advanced BCC, including the two advanced BCC patients described here, from an expansion cohort of this study. Stable disease or partial responses were achieved in eight out of nine patients (six partial responses, two stable disease) without significant toxicity.

This is the first study to evaluate a systemic Hedgehog antagonist in human clinical trials. Abnormal activation of the Hedgehog pathway appears to be an important mechanism for tumors to survive and grow. Mutations of the Hedgehog pathway have been implicated in the development of several tumors, such as BCC. Additionally, the progression of several solid tumor cancers has been associated with over-expression of the Hedgehog ligand, including colorectal cancer.

Genentech is initiating three Phase II studies of GDC-0449 this year. A Phase II study in first-line metastatic colorectal cancer began enrolling patients in Q2 2008 and other studies are planned in advanced BCC and an advanced epithelial tumor. Genentech is developing GDC-0449 under a collaboration agreement with Curis, Inc.

About Genentech
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines for patients with significant unmet medical needs. The company has headquarters in South San Francisco, California and is listed on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit

For the full prescribing information and Boxed Warnings for Avastin, Herceptin and Rituxan please visit

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