SOURCE: Paragon Financial Limited

Paragon Financial Limited

October 24, 2012 08:20 ET

Smaller, Faster Clinical Trials Considered by the FDA for Developers of Critical Drugs and Treatments

The Paragon Report Provides Stock Research on Keryx Biopharmaceuticals and ZIOPHARM Oncology

NEW YORK, NY--(Marketwire - Oct 24, 2012) - The Food and Drug Administration Commissioner Margaret Hamburg has told scientific advisers that the FDA is considering a faster pathway for obesity treatments, life-saving antibiotics and other drugs deemed to offer societal benefit. The Paragon Report examines investing opportunities in the Biotech Industry and provides equity research on Keryx Biopharmaceuticals (NASDAQ: KERX) and ZIOPHARM Oncology Inc. (NASDAQ: ZIOP).

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Under the new pathway the FDA would allow developers of such drugs to conduct smaller, faster clinical trial, and provide a "special medical use" label which would allow doctors to administer drugs to patients with critical need. Hamburg has said that the FDA needs to take into account the needs people with deadly or debilitating diseases that may be willing to take on the risks of unproven drugs.

"A pathway that would allow products to come to market faster but would ensure they were used only in patients where there was an applicable risk-benefit situation would be good," said Pew Health Group's Allan Coukell, deputy director of medical programs. "It would be good for developers, for companies and it would be good for public health."

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Keryx is developing Zerenex, an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. "We are well-positioned to complete the Phase 3 long-term study for Zerenex in the fourth quarter of 2012 and we expect to have New Drug Application filings across all three key phosphate binder territories, the U.S., EU and Japan, in the first quarter of 2013," said Keryx CEO Ron Bentsur.

ZIOPHARM Oncology is a biopharmaceutical company focused on the development and commercialization of new cancer therapies. ZIOPHARM's portfolio is comprised of five clinical-stage product candidates in all phases of development, as well as multiple research-stage candidates. Study results for the company cancer drug, Palifosfamide, are expected by the end of 2012.

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