Unregistered User If this is not your name, click here.
		Contact Us | Order Now | Journals | Bookstore | Register a colleague
	Select a ChannelAcneAIDS and HIVAllergy OtherAlzheimer'sAnaesthesiology OtherAngina Pectoris/MIAnxietyArthritis OtherAsthmaBack PainBacterial InfectionsBladder CancerBone Marrow TransplantationBreast CancerCardiology OtherCataractCell TransplantationCervical CancerCholesterol/Lipid disordersCirrhosisClinical PharmacologyColorectal CancerCongestive Heart FailureContact DermatitisContraceptionCOPDCystic FibrosisDental and Oral DisordersDepressionDermatology OtherDiabetesDialysisEating DisordersElbowEmergency MedicineEndocrinology OtherEpilepsyErectile DysfunctionFibromyalgiaGastro OtherGeneticsGenitourinary OtherGeriatricsGERD/GastritisGlaucomaH. Pylori/UlcerHaematology OtherHair LossHeadachesHepa/Biliary OtherHepatitisHipHRTHypertensionIBDImmunologyInfectious OtherInfertilityIntensive CareIrritable Bowel SyndromeKneeLeukemiasLiver CancerLung CancerLupusLymphomasMelanomaMenopauseMultiple Sclerosis Nephrology OtherNeurologic OtherNutritional / Metabolic OtherOb/Gyn OtherObesityOncology OtherOphth. OtherOphthalmic SurgeryOrgan TransplantationOrthopaedics OtherOsteoarthritisOsteoporosisOtitisOtorhino. OtherOvarian CancerPaediatricsPainPancreatic CancerParkinson'sPregnancyProstate CancerPsychiatry OtherPulmonary OtherRadiologyRenal CancerRenal FailureRespiratory InfectionsRheumatoid arthritisRheumatology OtherRhinitisSchizophreniaShoulderSleep ApnoeaSleep DisordersSpineStrokeSTDsSurgeryThyroid DisordersTransfusionTransplant Surgery OtherTraumaUrinary IncontinenceUrinary tract infectionsVaccinologyVascular DisordersViral Infections

SEARCH   News Bookstore Medline The Web Meetings & Congresses Complete Doctor's Guide    EXPLORE :    All News   All Webcasts   All Cases   All Meetings & Congresses   All Medical Resources New drugs / indications English Dictionary Medical Dictionary Thesaurus Warning | Privacy | Awards  Favourite Journals  Click here to choose your favourite journals  Favourite Sites  Click here to choose your favourite sites  Languages  Select languageEnglishFrançais

Pilot Clinical Study of Genasense (oblimersen sodium) Plus Rituxan and Fludarabine Shows Activity in Chronic Lymphocytic Leukemia Study Supports Safety and Potential Activity for the Regimen ATLANTA, GA -- December 12, 2005 -- Genta Incorporated announced the presentation of preliminary clinical results regarding the use of its lead anticancer compound, Genasense(R) (oblimersen sodium) Injection, in combination with fludarabine plus rituximab (Rituxan(R); Genentech/IDEC) in patients with chronic lymphocytic leukemia (CLL). The data were presented this weekend at the 47th Annual American Society of Hematology meeting in Atlanta, GA. Two clinical studies have explored the use of Genasense plus rituximab, with and without cytotoxic chemotherapy, in patients with non-Hodgkin's lymphoma. The goal of this ongoing Phase 1-2 study was to evaluate safety and preliminary activity across a range of fludarabine and Genasense doses when used in combination with a "stepped dosing" schedule of rituximab. The first 24 patients were treated in cycle 1 with 1.5 mg/kg/day of Genasense (50% of the usual CLL dose) for 7 days, plus 3 days of fludarabine (25 mg/m(2)/day), and two rituximab doses (125 and 250 mg/m(2)/d on days 4 and 6, respectively). In cycles 2 through 6, the Genasense dose was escalated to 3 mg/kg/day and the rituximab dose (375 mg/m(2)) was given once on day 5. Of these patients, 19 had relapsed from previous treatment and five were previously untreated. All five previously untreated patients achieved a major response, including one "molecular" complete response (mCR) (i.e., confirmed by two-color flow cytometry), one nodular partial response (nPR), and three partial responses (PR). Sixty-eight percent (68%) of the previously treated patients had received therapy with rituximab, and 74% had previously received fludarabine. Nonetheless, 10 of the 19 previously treated patients achieved major responses, including one mCR, one nPR, and 10 PR. Seven patients developed Grade 3 rituximab-associated infusion reactions, two of which were considered serious. However, most of these reactions occurred during the first cycle of treatment, and most patients were able to continue rituximab treatment. No other serious reactions occurred in more than 1 patient each. Having demonstrated adequate safety in the initial cohort, accrual is continuing to a second cohort wherein full doses of all three drugs including fludarabine at 25 mg/m(2)/day for 5 days. A randomized Phase 3 trial of 241 patients who received fludarabine plus cyclophosphamide (Flu/Cy) with or without Genasense showed that the addition of Genasense was associated with a significant increase in the proportion of patients who achieved a CR or nPR. All CR/nPRs in the Genasense group were "durable" (i.e., > six months in duration) and lasted significantly longer than the CR/nPRs that occurred in patients treated with Flu/Cy alone. This level of response was associated with significant clinical benefit, including relief of prospectively defined symptoms of CLL. Genta expects to complete its submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Genasense in combination with fludarabine and cyclophosphamide in patients with relapsed or refractory CLL later this month. About Genasense Genasense is the first oncology drug to directly target the biochemical pathway known as apoptosis whereby cancer cells are ultimately killed by chemotherapy. A protein known as Bcl-2 is highly expressed in many forms of human cancer and is believed to be a fundamental cause of resistance to anticancer therapy. By inhibiting production of Bcl-2, Genasense may enhance the activity of many forms of anticancer treatment. SOURCE: Genta Incorporated E-mail this page to a friend or colleague! To print, use this version