In any case, they are going with 120mg/m2/day . . .
>>CAMBRIDGE, Mass, Oct. 2 /PRNewswire-FirstCall/ -- Hybridon, Inc. (OTC Bulletin Board: HYBN.OB - News) announced the publication of the results from a clinical safety study of GEM®231, a 2nd-generation antisense oligonucleotide targeted to the RI alpha regulatory subunit of protein kinase A (PKA). The article, entitled "A Safety Study of a Mixed-Backbone Oligonucleotide (GEM231) Targeting the Type I Regulatory Subunit alpha of Protein Kinase A Using a Continuous Infusion Schedule in Patients with Refractory Solid Tumors," appears in the current issue of Clinical Cancer Research (Vol. 9, Number 11, pages 4069-4076, September 15, 2003).
In the clinical safety study, fourteen cancer patients received escalating doses of GEM®231 as a 3-day (1 patient) or 5-day (13 patients) continuous intravenous infusion at 80 to 180 mg/m2/day. The dose of 120 mg/m2/day was evaluated in 8 patients and was established as the dose to be recommended for phase 2 studies. There was low-grade fatigue in 57% of patients that was cumulative over 4-6 weeks of repeated 5-day infusions and that rapidly reversed at the end of treatment. Medically insignificant, but dose-related, reversible increases in serum transaminases and activated partial thromboplastin times were also observed.
"With this study and other clinical studies conducted by us, we now have given GEM®231 safely by infusions ranging from 2 hours to 5 days in duration. This flexibility is important for combination trials with various anticancer agents," said R. Russell Martin, M.D., Hybridon's Senior Vice President of Drug Development. "Our ongoing Phase 1/2 clinical trial combining GEM®231 and irinotecan is using the 5-day infusion schedule."
The authors of the present publication are Sanjay Goel, M.D., Kavita Desai, M.D., Anca Bulgaru, M.D., Abbie Fields, M.D., Gary Goldberg, M.D., and Sridhar Mani, M.D., (Albert Einstein College of Medicine), and Sudhir Agrawal, D. Phil., Russell Martin, M.D., and Michael Grindel Ph.D. (Hybridon).<<
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Cheers, Tuck |
