Drug Discovery & Development - September 16, 2010
Harbor BioSciences, Inc. a biopharmaceutical company developing novel therapeutics for the treatment of cancer, metabolic and inflammatory diseases, released new positive data from its ongoing Phase 1/2a clinical trial with Apoptone (HE3235) for castration resistant prostate cancer (CRPC) -- also referred to as hormone resistant prostate cancer.
The most current results from this study include data on the 100 mg and 350 mg cohorts of chemotherapy-naive patients. One patient in the 350 mg group has a confirmed partial overall response of the disease. The median time to progression (TTP) for the 100 mg cohort is 24 weeks. The median TTP has not been reached for the 350 mg dose.
Bruce Montgomery, M.D., Associate Professor, Department of Medicine, Division of Oncology, University of Washington School of Medicine, and lead investigator of the ongoing Phase I/IIa clinical trial remarked:
"This is an exciting finding because, at the 350 mg dose, we are seeing a quantitative response by RECIST criteria. This response correlates with the patient having the highest serum levels seen thus far and without any evidence of toxicity. Further dose escalation is justified to explore the promise of activity at higher serum concentrations of the drug."
Dose escalation to 700 mg has been initiated based on both the quantitative response and experience with the 350 mg dose, which demonstrate that the drug is safe and well tolerated.
A novel steroid analog of a testosterone metabolite, Apoptone has been found to induce cell death (apoptosis) in prostate tumors. The dose-response study was designed to determine safety and time to disease progression for both taxane-resistant and chemotherapy-naive patients with CRPC; and the study is being conducted with participating sites including the Prostate Cancer Clinical Trial Consortium (PCCTC).
The Phase I/IIa trial is an open-label study with the primary objective of assessing safety, tolerability, pharmacokinetics and activity of Apoptone in men with CRPC and an ECOG performance status score of less than or equal to 2 (ambulatory and capable of at least self-care).
Patient cohorts are defined by oral daily doses of 10, 20, 30, 50, 100, 200, 350 and 700 mg. Subjects are treated on 28-day cycles until toxicity or disease progression; CT and bone scans are obtained every two cycles to assess progression. Responding patients in both the chemotherapy-experienced and chemotherapy-naive groups will continue to be offered treatment under the current protocol.
Date: September 14, 2010
Source: Harbor BioSciences, Inc.
The most current results from this study include data on the 100 mg and 350 mg cohorts of chemotherapy-naive patients. One patient in the 350 mg group has a confirmed partial overall response of the disease. The median time to progression (TTP) for the 100 mg cohort is 24 weeks. The median TTP has not been reached for the 350 mg dose.
Bruce Montgomery, M.D., Associate Professor, Department of Medicine, Division of Oncology, University of Washington School of Medicine, and lead investigator of the ongoing Phase I/IIa clinical trial remarked:
"This is an exciting finding because, at the 350 mg dose, we are seeing a quantitative response by RECIST criteria. This response correlates with the patient having the highest serum levels seen thus far and without any evidence of toxicity. Further dose escalation is justified to explore the promise of activity at higher serum concentrations of the drug."
Dose escalation to 700 mg has been initiated based on both the quantitative response and experience with the 350 mg dose, which demonstrate that the drug is safe and well tolerated.
A novel steroid analog of a testosterone metabolite, Apoptone has been found to induce cell death (apoptosis) in prostate tumors. The dose-response study was designed to determine safety and time to disease progression for both taxane-resistant and chemotherapy-naive patients with CRPC; and the study is being conducted with participating sites including the Prostate Cancer Clinical Trial Consortium (PCCTC).
The Phase I/IIa trial is an open-label study with the primary objective of assessing safety, tolerability, pharmacokinetics and activity of Apoptone in men with CRPC and an ECOG performance status score of less than or equal to 2 (ambulatory and capable of at least self-care).
Patient cohorts are defined by oral daily doses of 10, 20, 30, 50, 100, 200, 350 and 700 mg. Subjects are treated on 28-day cycles until toxicity or disease progression; CT and bone scans are obtained every two cycles to assess progression. Responding patients in both the chemotherapy-experienced and chemotherapy-naive groups will continue to be offered treatment under the current protocol.
Date: September 14, 2010
Source: Harbor BioSciences, Inc.
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