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Affinium Pharmaceuticals Announces the Initiation of a Phase I Clinical Trial Using an Optimized Oral Formulation of AFN-1252, its Novel Anti-staphylococcal Antibiotic


4/12/2010 10:55:19 AM

AUSTIN, TX, April 12 /PRNewswire/ - Affinium Pharmaceuticals announced today the commencement of a Phase I study in the United States for its novel molecular entity, AFN-1252, a first in class antibiotic candidate focused on the oral and IV treatment of susceptible and highly resistant strains of Staphylococcus aureus (MRSA). The study will evaluate the safety and tolerability of a new, oral tablet formulation.

Dr. Barry Hafkin, Chief Medical Officer of Affinium Pharmaceuticals, noted, "We have previously documented good oral bioavailability and excellent tolerability of the drug candidate in two previous clinical studies using simple oral formulations, and we are very pleased to move a newly developed oral formulation that we expect will optimize the pharmacokinetic profile of AFN-1252. We anticipate that the trial will be completed in the third quarter of this year, and that AFN-1252 will continue to demonstrate the excellent tolerability and safety seen in previous studies."

About Affinium Pharmaceuticals

Affinium Pharmaceuticals is a specialty pharmaceutical company focused on the discovery and development of novel anti-infective medicines. Affinium's FASII antibacterial programs constitute a new antibiotic franchise with the potential for multiple products targeting the FASII pathway. These programs include a broad base of long-term intellectual property: issued and pending composition of matter patents on potent orally available small molecule inhibitors of a new class of antibiotics with a unique mechanism of action, targeting an underexploited pathway.

About AFN-1252

AFN-1252, the lead clinical candidate from Affinium's FASII program, is designed to selectively target the FabI enzyme found in staphylococci. AFN-1252 provides exceptional potency against all drug-resistant phenotpyes of staphylococci including hospital- and community-acquired methicillin-resistant Staphylocuccus aureus (MRSA) and coagulase-negative staphylococci. Extremely low propensity for microbial resistance development has been observed in microbiological studies. Oral bioavailability and excellent safety & tolerability have been demonstrated in two previous Phase 1 clinical trials and in human microdosing studies. The antibiotic has also shown excellent in vivo efficacy in animal models of infection. An injectable formulation is in pre-clinical development.

CONTACT: Barry Hafkin, Chief Medical Officer, Affinium Pharmaceuticals,
(416) 645-6614, bhafkin@afnm.com; Owen Roberts, Chief Financial Officer,
Affinium Pharmaceuticals, (416) 645-6613, oroberts@afnm.com



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