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Genta Poised To Restart Tesetaxel Studies

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA lifts clinical hold on Phase II oral taxane now headed back to the clinic in the second half.

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Time To Call It Quits: Genasense Failure Marks Its End And Leaves Genta On The Ropes Again

Genta ended a decade-long effort to validate the effectiveness of Genasense (oblimersen) with the May 23 announcement that the troubled antisense asset performed little better than chemotherapy alone in a targeted subset of patients with advanced melanoma.

Time To Call It Quits: Genasense Failure Marks Its End And Leaves Genta On The Ropes Again

Genta ended a decade-long effort to validate the effectiveness of Genasense (oblimersen) with the May 23 announcement that the troubled antisense asset performed little better than chemotherapy alone in a targeted subset of patients with advanced melanoma.

R&D IN BRIEF

Pfizer halts Phase III axitinib trial: Pfizer announces the halt of Phase III axitinib trial in advanced pancreatic cancer patients late on Friday, Jan. 30. The press release was overshadowed by the news just days earlier of Pfizer's offer to merge with Wyeth (1"The Pink Sheet," Feb. 2, 2009, p. 8). The pancreatic trial evaluating axitinib - Pfizer's most advanced oncology candidate - was stopped after a data safety monitoring board found no evidence in interim results of improvement in the primary endpoint of survival in patients treated with axitinib and gemcitabine compared to gemcitabine alone (the current standard of care). Pfizer had predicted last summer that it would first file axitinib for pancreatic cancer (2"The Pink Sheet," June 23, 2008, p. 30); the firm is still committed to evaluating the VEGF receptor inhibitor in a Phase III second-line renal cell carcinoma trial and Phase II advanced non-small cell lung cancer and colorectal cancer studies

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