Cytogen Presents Phase 1 Data Showing Promising Antitumor Activity,and Safety Profile of Quadramet at International Myeloma Workshop ( At the time of the presentation 32 pa...)

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Cytogen Presents Phase 1 Data Showing Promising Antitumor Activity,and Safety Profile of Quadramet at International Myeloma Workshop

At the time of the presentation, 32 patients were evaluable for response. Previous treatment with bortezomib was permissible.

-- Patients enrolled in the study had progressive disease despite receiving an average of 3.4 prior treatment regimens (median 3, range 1-8) and 21 of the 33 had relapsed following prior treatment with bortezomib.

-- Of the 32 evaluable patients, 14 received more than one treatment cycle. Response or stabilization of disease along with recovery from hematologic toxicity was required for administration of subsequent treatment cycles.

-- Six patients responded to the combination regimen, three of whom achieved a complete response (CR) and three a minor response (MR). Two of the patients achieving a CR received the protocol maximum four cycles (32 weeks) of treatment while the third has received two cycles (16 weeks) to date and remains on study. Similarly, one of the patients achieving a MR received the maximum four cycles (32 weeks) of treatment, one has received three cycles (24 weeks) to date and remains on study and the third has received two cycles (16 weeks) to date and remains on study.

-- Nine patients had stabilization of their disease, one has received one treatment cycle (8 weeks) to date and remains on study, four received two treatment cycles (16 weeks) with two still remaining on study, three received three treatment cycles (24 weeks) with two still remaining on study, and one received all four permitted treatment cycles (32 weeks).

-- Of the 15 patients who achieved a response or stablization of their disease, nine had previously failed treatment with bortezomib.

-- Toxicities were generally transient and manageable. Dose-limiting toxicity was observed in cohort six (1.0 mCi/kg of QUADRAMET and 1.3 mg/m(2) of bortezomib) thus, additional patients were enrolled in an extension of cohort three (1.0 mCi/kg of QUADRAMET and 1.0 mg/m(2) of bortezomib), which was not found to be dose-limiting,
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