Antitumor activity and toxicity were similar between the Injection and
Injectable Suspension products.
-- Of the 31 patients enrolled, 21 were treated with Kosan's Injection
product (Cremophor(R)-containing formulation and 10 were treated with
Kosan's Injectable Suspension product (contains no Cremophor). In
addition, 4 of the patients treated initially with the Injection
formulation crossed over to receive the Injectable Suspension
-- For the Injection product: 18 were evaluable and 11 responded
(4 PR, 4 tumor regressions, 3 SD), yielding a PR response rate of
22% and a clinical benefit incidence of 61%.
-- For the Injectable Suspension product: 9 were evaluable and 6
responded (3 PR, 1 tumor regression, 2 SD), yielding a PR response
rate of 33% and a clinical benefit incidence of 67%.
-- Patients with an objective response on the Injection product
maintained their objective response after crossover to the
Injectable Suspension product.
Tanespimycin plus trastuzumab was highly tolerable at the recommended Phase 2 dose of 450 mg/m2 weekly. Common toxicities were mainly mild-to-moderate diarrhea, fatigue, nausea, headache and vomiting (limited duration and amenable to supportive care). The few drug-related Grade 3 and 4 toxicities (including fatigue, increased AST and headache, two patients each) were manageable and only one patient discontinued treatment for an adverse event. Noticeably absent were toxicities common to cytotoxic chemotherapy including alopecia and myelosuppression. The Injectable Suspension product provided considerable advantages over the Injection product, including shorter time of infusion, no need for steroid or antihistamine premedications and ease of pharmacist preparation.
Kosan anticipates conducti
|SOURCE Kosan Biosciences Incorporated|
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