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Wednesday, 02/04/2009 8:25:13 AM

Wednesday, February 04, 2009 8:25:13 AM

Post# of 58465
Genasense® (oblimersen, Bcl-2 antisense): Researchers involved in a multicenter trial have reported that the addition of Genasense to Fludara® (fludarabine) and Cytoxan® (cyclophosphamide) improves the survival of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) who achieve a complete remission (CR) or near complete remission (nCR).10

Genasense is a Bcl-2 antisense oligodeoxynucleotide that is being evaluated for the treatment of multiple myeloma, acute myeloid leukemia (AML), CLL, melanoma, and acute lymphoid leukemia (ALL). Bcl-2 is a potent inhibitor of apoptosis. Over-expression of this protein in patients with a variety of malignancies is associated with resistance to chemotherapy. Genasense down-regulates Bcl-2 and has been investigated in several hematologic malignancies where Bcl-2 has been implicated in disease resistance. In vitro studies suggest that Genasense can down-regulate Bcl-2 activity and inhibit cell viability.

Researchers from several institutions have previously reported the outcomes of 241 patients with advanced CLL treated with Fludara and Cytoxan with or without Genasense.11 The addition of Genasense increased the proportion of patients who achieve CR/nCR from 7% in the Fludara/Cytoxan only arm to 17% in the Genasense arm. Overall response rates were not different between the two groups. Maximum benefit was observed in Fludara-sensitive patients, who had a fourfold increase in the CR/nCR rate. Responses were more durable in the patients receiving Genasense. The estimated median survival in the Genasense group was 33.8 months compared with 32.9 months in the chemotherapy-only group. The estimated three-year survival rate was 46% for the Genasense group and 37.5% for the chemotherapy only group.

In the ASCO 2008 presentation, researchers reported a median duration of CR of 22 months in patients receiving Fludara and Cytoxan; the median has not been reached for patients receiving Genasense. The median survival time for patients in CR has not been reached in the Genasense group, but was reached at 46 months in the non-Genasense group. The researchers reported that 12 of the 20 patients achieving a CR were alive in the Genasense group versus three of eight patients receiving Fludara and Cyoxan without Genasense. Complete response was continuing in five of 12 in the Genasense group versus zero of three in the Fludara and Cytoxan group. It was concluded that the addition of Genasense to Fludara and Cytoxan increased the CR rate, CR duration, and survival of patients achieving CR. The authors also suggest that CR is a valuable endpoint in evaluating therapies for CLL.

http://professional.cancerconsultants.com/oncology_main_news.aspx?id=43144

- Fludara® = Owned by Bayer

Cytoxan = Owned by Bristol Myers Squibb

2 HIGHLY respectable companies, and more potential buyers to the drug Genasense, or the company as a whole.

DD Credit: YesterdayTrader

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