CYLENE INITIATES PHASE I CLINICAL TRIAL FOR CX-3543.Cylene Pharmaceuticals, San Diego, Calif., an oncology drug discovery and development company, has initiated a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I for CX-3543, its lead candidate for the treatment of multiple cancers. CX-3543 is a first-in-class small molecule with a novel mechanism of action that selectively induces cancer cell death. The clinical trial is being conducted at the Cancer Therapy and Research Center in San Antonio, Texas “San Antonio” redirects here. For other uses, see San Antonio (disambiguation). San Antonio is the second most populous city in Texas, the third most populous metropolitan area in Texas, and is the seventh most populous city in the United States. As of the 2006 U.S. and at the Mayo Clinic in Scottsdale, Arizona. The clinical trial is currently open for enrollment and is designed to enroll approximately 36 patients with solid tumors or lymphomas. The objectives of the trial are to determine the safety and tolerability of CX-3543, to characterize its pharmacokinetic profile, to define dose-limiting toxicities and the maximum-tolerated dose, and to select the appropriate dose for Phase II trials. "We're very gratified grat·i·fy tr.v. grat·i·fied, grat·i·fy·ing, grat·i·fies 1. To please or satisfy: His achievement gratified his father. See Synonyms at please. 2. to advance CX-3543 into clinical trials," said William G. Rice, Ph.D., president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Cylene. "The novel mechanism of this compound engenders the potential for treating many types of cancers, and CX-3543 has shown very favorable safety and efficacy profiles during preclinical testing. Our world-class development team, led by Daniel Von Hoff, M.D. and John K.C. Lim, Pharm.D., along with our supportive investors, position us to rapidly advance CX-3543 while elevating other small molecule agents in our pipeline toward the clinic." "Preclinical findings with CX-3543 revealed target selectivity at the molecular level and excellent drug-like properties," said Cylene co-founder Daniel D. Von Hoff, M.D. "It has demonstrated a favorable in vivo in vivo /in vi·vo/ (ve´vo) [L.] within the living body. in vi·vo adj. Within a living organism. in vivo adv. safety profile, as well as compelling anti-tumor activity in xenograft xenograft /xeno·graft/ (zen´o-graft) a graft of tissue transplanted between animals of different species; it may be concordant, models of colorectal, pancreatic, and prostate cancers. I look forward to the molecule advancing through the clinic." About CX-3543 CX-3543 is a proprietary small molecule designed to selectively interact with quadruplex nucleic acid nucleic acid, any of a group of organic substances found in the chromosomes of living cells and viruses that play a central role in the storage and replication of hereditary information and in the expression of this information through protein synthesis. structures and induce apoptotic cell apoptotic cell Cell biology A dense, eosinophilic, pyknotic cell surrounded by a thin clear space, often lying within epithelium, which is due to apoptosis death in cancer cells. Preclinical studies with CX-3543 have demonstrated favorable pharmacokinetic properties, potent in vivo efficacy in murine murine /mu·rine/ (mur´en) pertaining to, derived from, or characteristic of mice or rats. mu·rine adj. xenograft models with a broad safety window, as well as practical formulation, stability and drug manufacturing properties. CX-3543 represents a first-in-class quadruplex-interactive small molecule to enter the clinic with the potential to affect a broad range of cancers. About Cylene Pharmaceuticals, Inc. Cylene Pharmaceuticals, Inc. is a privately held pharmaceutical company dedicated to the discovery, development and commercialization of first-in-class small molecule drugs to treat life-threatening cancers. Cylene's product pipeline is led by CX-3543, a quadruplex-interactive agent in Phase 1 clinical trials. CX-3543 and other molecules in the pipeline originate from the company's proprietary drug discovery platform. For more information, visit http://www.cylenepharma.com or call 858/875-5100. |
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