Dr Curiel/Viral Genetics' P-IND Clears FDA To Commence Clinical Trials (ovarian cancer/Sorafenib) in Humans - MarketWatch

Viral Genetics' P-IND Clears FDA To Commence Clinical Trials in Humans - MarketWatch

Viral Genetics' P-IND Clears FDA To Commence Clinical Trials in Humans 

Set to Begin First Ovarian Cancer Study Test Site for Metabolic Disruption Technology (MDT) Combination Therapy

 

SAN MARINO, Calif., May 21, 2012 (BUSINESS WIRE) -- A physician-initiated Investigational New Drug (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' (pinksheets:VRAL) Metabolic Disruption Technology (MDT), which is licensed exclusively to the Company. The P-IND -- part of a larger, coordinated research effort -- was submitted by the first test site at the Cancer Therapy & Research Center (CTRC) at The University of Texas Health Science Center at San Antonio, which includes patient enrollment at Scott and White Hospital (S&W) in Temple, Texas. Additional test sites may also be added in the future.

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.

This clinical trial -- a milestone in the Company's transition from preclinical to clinical-stage -- will be the first for the intellectual property developed by Dr. M. Karen Newell Rogers, Viral Genetics' Chief Scientist and licensed exclusively by the Company. It 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(TM)) in the treatment of patients resistant or otherwise unsuitable for standard treatments for stage III or IV ovarian cancer and related carcinomas.

The Primary Investigator on the trial is Tyler Curiel, M.D., MPH, a medical oncologist affiliated with the CTRC at the UT Health Science Center. Dr. Curiel is leading this study as he investigates the efficacy of combining two compounds in a cancer treatment that is hoped to cause the starvation of tumor cells and enhanced anti-tumor immunity, leading to the reduction of tumor size and reduced disease progression.....