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Affinium Pharmaceuticals Announces Initiation of a Phase I Clinical Trial for AFN-1252, its Novel Anti-staphylococcal Antibiotic


3/4/2008 8:49:13 AM

AUSTIN, TX and TORONTO, March 4 /PRNewswire/ - Affinium Pharmaceuticals today announced that they have commenced the dosing of healthy subjects in a Phase I study of AFN-1252, one of its lead clinical candidates from its novel class of fatty acid biosyntheis inhibitors. The study of AFN-1252 will evaluate the safety, tolerability and pharmacokinetics of a single escalating oral dose. Affinium believes that AFN-1252 will provide patients and their doctors a potent, oral and IV treatment for susceptible and resistant staphylococcal infections both in and out of hospitals.

AFN-1252 is an investigational antibiotic, with a novel mechanism of action, and very high potency against all drug-resistant phenotpyes of staphylococci including hospital and community-acquired MRSA. Oral bioavailability has previously been demonstrated in a human microdosing study and excellent in vivo efficacy has been demonstrated in various animal models of infection.

"Affinium is very pleased to advance this novel class of antibiotics with great potential to address the serious unmet medical need for new oral and IV antibiotics capable of treating multi-drug resistant staphylococcal infections," said Dr. Barry Hafkin, Chief Medical Officer of Affinium Pharmaceuticals. "In preclinical studies, AFN-1252 was well tolerated at high multiples of the projected human dose in two species, suggesting a safety profile that would be very attractive to physicians practicing both in and out of hospital settings." Dr. Hafkin added that "the specific-spectrum of activity of AFN-1252 may provide further safety advantages by decreasing the risk of gut and cutaneous flora disruption."

About Affinium Pharmaceuticals

Affinium Pharmaceuticals is a specialty pharmaceutical company focused on the discovery, development and commercialization of novel anti-infective medicines. AFN-1252 utilizes a unique mechanism of action by directly inhibiting the function of the bacterial fatty acid synthesis (FAS) II pathway. 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 and are not subject to resistance selection pressures caused by the use of existing broad spectrum antibiotics.

CONTACT: Barry Hafkin, Chief Medical Officer, Affinium Pharmaceuticals,
(512) 514-6631, bhafkin@afnm.com; Owen Roberts, Chief Financial Officer,
Affinium Pharmaceuticals, (416) 645-6613, oroberts@afnm.com



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