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| |  Phase II Clinical Trials Results of RMP-7 and Carboplatin CAMBRIDGE, Mass.—Dec. 16, 1996 -- Combination of Drug Delivery Agent and Chemotherapy Shows Positive Responses in Patients with Recurrent Brain Tumors -- Alkermes, Inc. (NASDAQ:ALKS) announced today the results of two European Phase II clinical trials of the combination of the drug delivery agent RMP-7(TM) and the chemotherapeutic agent carboplatin delivered intravenously to patients with recurrent, malignant brain tumors. The results showed that the drug combination was well tolerated and provided positive responses as measured by patients' neurological impairment, performance status and tumor volume. Study ALK01- 013 and Study ALK01-019 were multi-center, open label clinical trials conducted in a total of 14 medical centers in the United Kingdom, France and Sweden. The two clinical trials were designed to test the safety and efficacy of intravenous RMP-7 and carboplatin in the treatment of patients with recurrent, malignant brain tumors (anaplastic astrocytoma or glioblastoma multiforme, World Health Organization grades 3 or 4). Two patient groups with different prognostic outcomes were studied: -- Study -013 enrolled patients who had relapsed following previous treatment with surgery and radiotherapy. 45 patients were treated at 9 centers in the United Kingdom. Treatment with RMP-7 and carboplatin was generally well tolerated, and resulted in positive responses in 61 percent to 87 percent of patients as measured by tests of their neurological impairment and performance status, and positive responses in approximately 75 percent of patients as measured by the size of their tumor on magnetic resonance imaging (MRI). An independent analysis conducted by a statistician from the Medical Research Council (MRC), Cambridge, England compared the effect on survival of treatment with RMP-7 and carboplatin versus a group of historical control patients matched on important prognostic factors. All comparisons favored the group treated with RMP-7 and carboplatin versus the historical control group (hazard ratio 1.9-2.2, p<=0.02, after accounting for the effects of prognostic factors). -- Study -019 enrolled further advanced patients who had relapsed following previous treatment with surgery, radiotherapy and chemotherapy. 42 patients were treated at 11 centers in the United Kingdom, France and Sweden. Treatment with RMP-7 and carboplatin was generally well tolerated, and resulted in positive responses in 40 percent to 57 percent of patients as measured by neurological impairment and performance status, and positive responses in approximately 25 percent of patients as measured by tumor size on MRI. The MRC did not perform a comparison of patients in Study -019 to historical controls due to the lack of a database of comparable patients who had failed surgery, radiotherapy and chemotherapy. "The fact that response rates are consistently high across all of the analyses provides confirmation that the treatment is working in practice," said Dr. Anna Gregor, MD, Professor, FRCP, FRCR, University of Edinburgh, and a principal investigator in both Study -013 and Study -019. "The studies used multiple objective techniques to assess the treatment effect. The results show that the combination of RMP-7 and carboplatin is well tolerated and provides important benefits to recurrent brain tumor patients." Current treatment for malignant brain tumors is limited and inadequate. After initial treatment with surgery and/or radiotherapy, malignant brain tumors generally recur. Upon recurrence, tumors typically progress rapidly, neurological function and quality of life deteriorate and patients die within months. Chemotherapy has played only a limited role in treatment, in part due to the limited access of many chemotherapeutic agents to the brain because of the normally restrictive blood-brain barrier. Carboplatin is a chemotherapeutic agent approved for use by the United States Food and Drug Administration and other regulatory authorities worldwide for use in the treatment of various tumor types outside of the brain, but is limited in its ability to penetrate into the brain. RMP-7 is designed to enable more effective use of chemotherapeutic agents like carboplatin in the treatment of brain tumors by transiently increasing the permeability of the blood-brain barrier. In Study -013 and Study -019, patients received treatment cycles of RMP-7 and carboplatin once approximately every four weeks. Each cycle consisted of a 15 minute intravenous infusion of carboplatin and a concurrent 10 minute intravenous infusion of RMP-7 (300 ng/kg). The prospectively designed endpoints of the studies included response rates over the first four cycles of treatment as determined by (i) stabilization or improvement for a minimum of two cycles of treatment as measured by three standardized tests of neurological impairment and patient performance status: The Edinburgh Functional Impairment Test (EFIT), the Medical Research Council Neurological Status Scale, and Karnofsky Performance Status; (ii) stabilization or reduction in tumor volume by at least 50 percent for a minimum of two cycles as measured by contrast-enhanced MRI; and (iii) survival. Treatment with the combination continued until a patient's clinical status deteriorated or there was evidence of tumor progression by the EFIT or MRI. "The successful completion of these two European clinical trials is an important milestone in our development program for RMP-7 as an agent to increase drug delivery to the brain," said Richard F. Pops, Chief Executive Officer of Alkermes. "We are pleased to see that in both studies the combination of RMP-7 and carboplatin is well tolerated and that positive responses, measured by neurological impairment, performance status and tumor size, were observed." RMP-7 is being developed by Alkermes for Alkermes Clinical Partners, L.P., a limited partnership which raised $46 million in 1992 to develop RMPs(TM). Alkermes has the option to purchase the partnership's technology. Alkermes is a leader in the development of products based on sophisticated drug delivery technologies. Alkermes' focus is on two important drug delivery opportunities: (i) controlled, sustained release of injectable drugs lasting several days to several weeks, utilizing its ProLease(R) and Medisorb(R) technologies; and (ii) the delivery of drugs into the brain past the blood-brain barrier, utilizing its RMP-7 technology. In addition to its Cambridge, Massachusetts headquarters, Alkermes operates a manufacturing facility in Ohio and a medical affairs office in Cambridge, England. This press release contains forward-looking statements regarding Alkermes, Inc. Actual results could differ materially from those described in this press release as a result of a number of factors, including, but not limited to the following: There can be no assurance that any product in the Alkermes product pipeline will be successfully developed or manufactured, or that final results of human clinical trials will be supportive of regulatory approvals required to market products, or that final regulatory approval will be received in a timely manner, if at all, or that patient and physician acceptance of these products will be achieved. The company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this release.
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