Revlimid(R) Delays Time to Disease Progression in Previously Treated Multiple Myeloma Patients
Thursday, April 17th, 2008Celgene Corporation (Nasdaq: CELG) announced that REVLIMID(R) clinical information be presented at an ASCO Scientific Symposium by Sunday, May 15. The viewing provide updated grades from the Pivotal Phase III Special Protocol Assessment (SPA) try-out using REVLIMID contained by the nursing of once treat patients near go back to your old ways or refractory multiple myeloma. The study report overwhelmingly profitable statistically indicative incongruity in median TTP, the initial endpoint of the two trials. The analysis be base on clinical data accessible in defences of of March 31, 2005. The median TTP in elect to choose of the North American trial (MM-009) was 60.1 weeks and for the International trial (MM-010) was 53.4 weeks. This be in judgment to the TTP for the placebo plus dexamethasone arsenal where the median TTP was 20.7 weeks and 20.6 weeks, respectively.
Multiple myeloma is the second record rife cancer of the blood, representing about one percent of all cancer and two percent of all cancer death with a reported overall clasp of approximately 200,000 cases. In the year 2004, in that were an justly accurate 74,000 bathe cases of multiple myeloma worldwide. The estimated signs of deaths from multiple myeloma in 2005 was around 60,000 worldwide.
“The North American and International Multiple Myeloma Phase III trials reported a significant clinical advantage for patients treated with REVLIMID plus dexamethasone. In multiple myeloma patients with rainproof virus, REVLIMID plus dexamethasone greater than double the rejoinder rate initiate with placebo plus dexamethasone wish that REVLIMID own the soon-to-be to be an critical new agent for multiple myeloma patients,” explain Donna Weber, M.D., Associate Professor, Lymphoma/Myeloma of The University of Texas MD Anderson Cancer Center.
At the ASCO Scientific Symposium, Dr. Weber presented the results of the North American and International Multiple Myeloma Phase III trials. Dr. Weber lead the North American Phase III trial (MM-009), a randomized, double-blinded, placebo-controlled trial, using REVLIMID plus dexamethasone, versus placebo plus dexamethasone in pretreated relapsed or refractory multiple myeloma patients. This research enrol 354 patients from 47 clinical site for the duration of North American with data available from 171 patients randomized to REVLIMID plus dexamethasone and 171 patients randomized to placebo plus dexamethasone. The median lax age was 64 years in the REVLIMID plus dexamethasone arm, compared to 62 years in the placebo plus dexamethasone arm of the trial. An Independent Data Monitoring Committee review the tactical period separating analysis of clinical data and sure that the North American Phase III trial overwhelmingly exceed the pre-specified efficacy stop directive of p 0.0015 for the primary endpoint, time-to-disease encroachment. Consistent with the findings of the interim analysis, available since March 31, show longest response rates of 61.2% in patients treated with REVLIMID(R) plus dexamethasone, compared to 22.8% of patients treated with placebo plus dexamethasone.
“Multiple myeloma is an infection with a discouraging closing stage result, but today, with advance such as REVLIMID, there is a potential for myeloma to become a ingrained illness for the majority of patients worldwide,” explained Meletios Dimopoulos, M.D., Professor of Therapeutics at The University of Athens School of Medicine, Greece.
Dr. Dimopoulos led the International Phase III trial (MM-010), a randomized, double-blinded, placebo-controlled trial, using REVLIMID plus dexamethasone, versus placebo plus dexamethasone in previously treated relapsed or refractory multiple myeloma patients. This study enrolled 351 patients from 50 clinical sites worldwide with data available from 176 patients randomized to REVLIMID plus dexamethasone and 175 patients randomized to placebo plus dexamethasone. The median patient age was 63 years in the REVLIMID plus dexamethasone arm, compared to 64 years in the placebo plus dexamethasone arm of the trial. An Independent Data Monitoring Committee reviewed the planned interim analysis and determined that this International Phase III trial overwhelmingly exceeded the pre-specified efficacy stopping rule of p 0.0015 for the primary endpoint, time-to-disease progression. Consistent with the findings of the interim analysis, the available clinical data as of March 31, showed best response rates of 58.0% in patients treated with REVLIMID plus dexamethasone, compared to 21.7% of patients treated with placebo plus dexamethasone.
In both trials, patients treated with REVLIMID and dexamethasone have an escalate in mix effects as compared to those patients bachelor treated with placebo plus dexamethasone. Grade 3 / 4 toxicities incorporated neutropenia, thrombocytopenia and anemia. Deep capillary thrombosis be in motion on in 13.5 and 4.5% of patients treated with REVLIMID plus dexamethasone, compared to 3.5 and 3.4% of patients treated with placebo plus dexamethasone in the North American and International trials, respectively. Pulmonary embolism occurred in 2.9 and 4.0% of patients treated with REVLIMID plus dexamethasone, compared to 0.6 and 1.1% of patients treated with placebo plus dexamethasone in the North American and International trials, respectively.
About the North American and International Phase III SPA Trials These Phase III SPA studies were based on clinical data available weathered of March 31, 2005. These clinical data will disseminate to be assemble and updated, through patient persistence, on an ongoing foundation. These trials were designed to palpable enquiries the efficiency and safekeeping of syncopated dose of REVLIMID at 25mg cohesive with high-dose dexamethasone (HDD) compared with placebo and HDD in previously treated patients with multiple myeloma. These trials enrolled 705 patients and be a person conduct in 97 sites internationally. REVLIMID and HDD are given in 28-day cycle REVLIMID 25 mg once on a daily basis on Days 1-21 all 28 days, and HDD 40 mg on Days 1-4, 9-12 and 17- 20 every 28 days. After four cycles the HDD diary is reduced to 40 mg on Days 1-4 every 28 days). The primary endpoint of the study is time-to- progression calculated as the case in spear from randomization to the original documentation of free-thinking disease based on Blade myeloma response criterion.
“We are charmed that the updated data from these Phase III trials were special to be presented at such an important quantifiable symposium. These trials will be nearly new as the basis for our regulatory submission to the FDA and regulatory agencies around the world for REVLIMID(R) in previously treated multiple myeloma patients,” said Jerome B. Zeldis, M.D., Ph.D., Chief Medical Officer and VP, Medical Affairs of Celgene Corporation. “Based on these positive results, the trials have be unblinded and all patients are being offered REVLIMID. Celgene is planning REVLIMID expanded access programs in the U.S. and a characterize patient program in Europe, for patients who have relapsed or refractory multiple myeloma.” About REVLIMID REVLIMID is a contributor of a new spherical table of new-fangled immunomodulatory drugs, or IMiDs(R). Celgene is evaluate treatment with REVLIMID for a open catalogue of hematology and oncology provisos, with, multiple myeloma, the malignant blood cell disorder set as myelodysplastic syndrome also as glutinous tumor cancers. REVLIMID affect multiple intracellular birth pathway. The IMiD pipeline, including REVLIMID, is suffused with a disorganized quick belongings estate of U.S. and foreign issue exclusive rights and next patent lobby including composition-of-matter and development patents.
REVLIMID is not passed by the FDA or any other regulatory agencies as a treatment in any demonstration and is arrogate very shortly being evaluate in clinical trials for efficacy and safety for proposed regulatory applications.
About Multiple Myeloma Multiple myeloma (also known as myeloma or plasma cell myeloma) is a cancer of the blood in which malignant plasma cell are overproduced in the clean marrow. Plasma cells are white blood cells that serve cover antibodies call immunoglobulins that box pollution and disease. However, most patients with multiple myeloma have cells that produce a approach of immunoglobulin called paraprotein (or M protein) that in concert out not benefit the entity. In combination, the malignant plasma cells replace mundane plasma cells and other white blood cells important to the immune bloc. Multiple myeloma cells can also linkage to other tissues of the body, such as bone, and produce tumors. The bring of the disease overstatement unknown.
About Celgene Celgene Corporation, headquartered in Summit, New Jersey, is an integrated intercontinental biopharmaceutical formal off limits first and foremost in the telling, improvement and commercialization of anarchistic therapy for the treatment of cancer and inflammatory disease through gene and protein order. For more data, soothe face in the Company’s website at .
This release include correct forward-looking lecture which catch known and unknown risk, difficulty, uncertainties and other factor not beneath the Company’s normalize, which may cause actual results, activities or achievement of the Company to be materially conflicting from the results, performance or other expectations implied by these forward-looking statements. These factors bring in results of useful or pending research and development happenings, arrangements by the FDA and other regulatory authorities, and those factors detailed in the Company’s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
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