Viral Genetics' P-IND Clears FDA Process To Begin Clinical Trials In Humans

5/21/2012 4:31 PM ET

Viral Genetics Inc. (VRAL.PK) announced that a physician-initiated Investigational New Drug or P-IND application submitted to the FDA in late April, 2012, has cleared the FDA's screening process with the requirement for a regular IND application being waived, resulting in the company being able to begin the first of at least two proposed clinical trial sites to investigate a potential oncology treatment developed from Viral Genetics'Metabolic Disruption Technology or MDT, which is licensed exclusively to the Company.

Enrollment and treatment of patients is expected to commence upon completion of internal hospital Institutional Review Boards (IRBs), which are already underway. The UT Health Science Center portion of the study will commence when all approvals are finalized.

The company said the clinical trial will examine the safety and efficacy of one of Viral Genetics licensed MDT compounds in combination with an existing cancer drug, sorafenib (marketed as Nexavar) in the treatment of patients resistant or otherwise unsuitable for standard treatments for stage III or IV ovarian cancer and related carcinomas.

The Company expects to introduce various other drugs and drug combinations from both of its licensed MDT and Targeted Peptides Technology (TPT) platforms to the clinic throughout 2012 and in 2013 with the submission of several additional pre-IND, P-IND and regular sponsor IND applications.

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by RTT Staff Writer

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