Using Antisense, Monoclonal, and Standard Chemotherapy All Together

Tuesday, Genta (NASDAQ: GNTA) announced the initiation of a multicenter clinical trial in patients with mantle cell lymphoma (MCL), a rare, highly aggressive form of non-Hodgkin lymphoma (NHL). The investigation will assess Genta's antisense drug, Genasense, in combination with IDEC (NASDAQ: IDPH) and Genentech's (NYSE: DNA) monoclonal antibody Rituxan (rituximab) and standard CHOP chemotherapy. The trial includes both newly diagnosed and relapsed patients. Up-front Genasense treatment will be designed to sensitize the tumor to the subsequent therapeutic effects of combination therapy with Genasense, Rituxan, and CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone). MCL is a type of NHL characterized by various molecular genetic abnormalities including over-expression of Bcl-2. Bcl-2 over-expression allows cells to avoid apoptosis (programmed cell suicide), helping tumors to grow out of control and to resist anticancer therapy.

Genasense is an antisense drug that directly reduces the amount of Bcl-2 protein made by target cells. Experimentally, Genasense has demonstrated the ability to amplify the therapeutic effects of various forms of standard chemotherapy. This experimental synergy is being translated into therapeutic effects for patients with various Bcl-2 expressing solid and hematologic tumors. Phase III results for Genasense combined with chemotherapy to treat melanoma, multiple myeloma, and acute myelogenous leukemia are key drivers not only for Genta but for other companies developing antisense therapeutics. Results of these trials should be available in April or May 2002. We expect data from ongoing efficacy-deriving clinical trials to show a reassuring magnitude of treatment effect profile across a broad range of tumor types. Genta is relying on these three clinical trials to generate high-powered evidence of the clinical utility of Genasense. In malignant melanoma and multiple myeloma, extended endpoints such as survival and time to disease progression will be especially important. In chronic lymphocytic leukemia, time to disease progression and/or disease-free survival is more important. Success with any of these parameters suggests that Genasense will be approved as a chemosensitizer over a broad range of tumor types. More information can be found in Btech Investor Reports: Fighting Disease with DNA and RNA (November 9, 2001). Rituxan's ability to favorably combine with both CHOP (clinically) and Genasense (experimentally) gives this new trial an above average chance of success.

If successful, the trial will not only benefit Genasense development, but also be one of many new opportunities for Rituxan. Use of the IDEC anti-cancer blockbuster will continue to expand into multiple clinical scenarios. In addition to use with Genasense, another compelling area for future Rituxan use is in combination with Immunomedics (NASDAQ: IMMU) and Amgen's (NASDAQ: AMGN) Epratuzumab. Combination trials for Rituxan and CHOP have already demonstrated a significant magnitude of treatment effect in patients with both indolent and aggressive NHL, as well as newly diagnosed follicular NHL. The continued utility demonstrated by Rituxan combination therapy supports IDEC's goal that most, if not all, patients with NHL will be treated with Rituxan.

BTECH NEWS
by Leon Henderson, M.D.
Bennett Weintraub, Ph.D.
Christopher Martin
www.btechnews.com
February 20, 2002

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BTECH NEWS, published by Btech Investor, Inc., highlights selected events in the life sciences sector that the Btech Investor team believes are particularly relevant to biotechnology investors. The Btech Investor team combines scientific, clinical, and business experience to perform comprehensive analysis of the biotechnology industry and to identify future industry leaders.

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