Cylene Pharmaceuticals, Inc. Announces Issuance Of Additional U.S. Patents Covering Lead Compound CX-3543, Strengthening Cylene’s Intellectual Property Position In rRNA Biogenesis Inhibition

SAN DIEGO, Jan. 31 /PRNewswire/ -- Cylene Pharmaceuticals, Inc. announced today that the United States Patent and Trademark Office (USPTO) issued a ‘Composition of Matter’ patent for a patent application entitled “Substituted Quinobenzoxazine Analogs.” The newly allowed claims strengthen Cylene’s position as a leader in the field of ribosomal RNA (rRNA) biogenesis inhibition. A supporting patent was also issued for a patent application entitled “Heterocyclic Substituted 1,4-Dihydro-4-Oxo-1,8-Naphthyridine Analogs,” which covers potential backup compounds to Cylene’s lead compound, CX-3543.

Key kinase, cell cycle, oncogenic transcription factor and tumor suppressor pathways converge on the RNA Polymerase I (Pol I) machinery to regulate the rate of synthesis of ribosomal RNA (rRNA) and thus regulate cell growth and proliferation. Mutations in the proteins of these pathways lead to excessive rRNA biogenesis and unbridled growth and proliferation in cancer cells. Numerous commercially-successful cancer drugs exert their effects indirectly through the rRNA biogenesis pathway, making this a validated pathway to target for new cancer drugs.

Cylene’s targeted small-molecule oncology compound, CX-3543, directly inhibits rRNA biogenesis by targeting a protein: DNA interaction that is amplified during Pol I transcription of the rRNA genes of cancer cells. This protein: DNA interaction (Nucleolin protein and G-quadruplex motif) is selectively disrupted by CX-3543 and induces apoptotic cell death in cancer cells. CX-3543 demonstrates in vivo efficacy with a broad therapeutic window in xenograft models using multiple types of cancers, and biomarker analyses supported the in vivo antitumor effect on rRNA biogenesis leading to apoptosis of tumor cells. Thus, inhibition of rRNA biogenesis is an important new approach in oncology drug discovery and development.

CX-3543 is in late stage Phase I clinical studies in patients with advanced solid tumors. Recent clinical data were presented in a poster during the 2006 ASCO (American Society of Clinical Oncology) Annual Meeting in Atlanta, Georgia this past June.

“Cylene has expended enormous efforts to design, develop and confirm the mechanism of antitumor action of CX-3543. Allowance of the patent claims covering the composition of matter and mechanism of action claims around this breakthrough agent is a key milestone,” said William G. Rice, Ph.D., Cylene Chief Executive Officer.

About Cylene Pharmaceuticals, Inc.

Cylene Pharmaceuticals is a biotech pharmaceutical company dedicated to the discovery, development and commercialization of targeted small-molecule drugs to treat life-threatening cancers. Using its proprietary Ribosomal RNA Biosynthesis Inhibition Technology (RABIT(TM)) to design molecules that combat drug-resistant forms of cancer, Cylene has created multiple product candidates in different stages of development. Cylene’s most advanced cancer agent, CX-3543, is a Ribosomal RNA Biogenesis Inhibitor (RBI) in late-stage Phase 1 clinical development. More information can be found at www.cylenepharma.com.

Cylene Pharmaceuticals, Inc.

CONTACT: William Rice, Ph.D., President and CEO of Cylene Pharmaceuticals,+1-858-875-5100, wrice@cylenepharma.com; or Karen Sparks of Mentus,+1-858-455-5500, ext. 275, karen@mentus.com, for Cylene Pharmaceuticals,Inc.

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