FDA Issues Nonapprovable Letter to Maxim for Histamine Dihydrochloride New Drug Application.Business Editors & Health/Medical Writers BIOWIRE2K SAN DIEGO--(BW HealthWire)--Jan. 19, 2001 Maxim Pharmaceuticals (Nasdaq:MAXM)(SSE (1) An earlier full-screen editor in OS/2. (2) (Streaming SIMD Extensions) A series of additional instructions built into Pentium CPU chips for improved multimedia performance by performing mathematical operations on multiple sets of data at the :MAXM) announced that it received a nonapprovable letter today from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) relating to the Company's New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for Ceplene(TM) (histamine dihydrochloride, formerly Maxamine(R)) as an adjuvant to interleukin-2 (IL-2) for the treatment of patients with advanced metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. melanoma with liver metastases. The FDA stated that the U.S. Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. forming the basis of the NDA would not be adequate as a single study to support approval. "This event was expected as a result of the outcome of the Oncologic Drugs Advisory Committee meeting in December," said Larry G. Stambaugh, Maxim's chairman and chief executive officer. "Despite this regulatory action, the trial did show a significant survival benefit in a patient population with a fatal disease that has a critical need for more effective therapies. We will meet with the FDA to develop a clinical strategy to support the approvability of this drug in this patient population." Maxim Pharmaceuticals is a biopharmaceutical company developing advanced drugs and therapies for cancer and infectious diseases. In addition to the recently completed Phase 3 trial in advanced metastatic melanoma, Maxamine is also currently being tested in two additional Phase 3 cancer clinical trials in 12 countries for advanced metastatic melanoma and acute myelogenous leukemia acute myelogenous leukemia n. Abbr. AML Myelogenous leukemia characterized by rapid abnormal increase in the number of myeloblasts and progression of symptoms. . Phase 2 trials of Maxamine are also underway for the treatment of hepatitis C and advanced renal cell carcinoma renal cell carcinoma or hypernephroma Malignant tumour of the cells that cover and line the kidney. It usually affects persons over age 50 who have vascular disorders of the kidneys. It seldom causes pain, unless it is advanced. . The Company has also developed product candidates based on its MaxDerm(TM) technology that are designed for the treatment of medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions. Lastly, Maxim is developing small-molecule inhibitors and activators of caspases, key enzymes that modulate and carry out the cellular signaling pathways involved in programmed cell death pro·grammed cell death n. See apoptosis. programmed cell death proposed system of cell death, often including poly(ADP)-ribosylation, ensures that a cell will not survive if it is so badly damaged that its recovery would harm the , also known as apoptosis. Compounds that can either inhibit caspases or induce caspases may form the basis for important new drugs for a wide variety of disease targets, such as cancer, cardiovascular disease and other degenerative diseases. This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding the efficacy and intended utilization of Ceplene, MaxDerm and the caspase modulator Modulator Any device or circuit by means of which a desired signal is impressed upon a higher-frequency periodic wave known as a carrier. The process is called modulation. The modulator may vary the amplitude, frequency, or phase of the carrier. compounds, and regarding the Company's clinical trials. Such statements are only predictions and the Company's actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in larger-scale clinical trials and the risk that the Company will not obtain approval to market its products. These factors and others are more fully discussed in the Company's periodic reports and other filings with the Securities and Exchange Commission. Note: Maxamine(R), Ceplene(TM), MaxDerm(TM) and the Maxim logo are trademarks of the Company. Editor's Note: This release is also available on the Internet at: http://www.maxim.com. |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion