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

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

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

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

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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™) 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.

An internationally recognized expert and speaker in tumor immunology and in the humanities, Dr. Curiel has been a featured scientist on the NOVANow Science Television program on PBS, and is the recipient of numerous medical and civic service awards including the Mauveny Prize for Cancer Research from Tulane University, the STARS Research Enhancement Award from the University of Texas and the Health Care Hero Award from the San Antonio Business Journal. Dr. Curiel holds membership in a multitude of professional organizations and sits on the Editorial Boards of several publications including The Journal of Immunology and The Journal of Clinical Investigation.

Discussing Dr. Curiel's role as lead investigator and study chair, Viral Genetics' Chief Scientist, Dr. M. Karen Newell Rogers said, “As one of the country's foremost ovarian cancer specialists, having Dr. Curiel as our primary investigator is an honor and we are grateful for the opportunity to validate MDT science as an approach to cancer therapy. MDT shows great promise across a broad spectrum of cancers, and other disease states. A successful clinical trial for this specific carcinoma using this combination approach could allow us to offer a new treatment option for many women and relief to their families.”

The Company looked to start similar clinical trials utilizing MDT compounds on certain cancers at S&W in 2011, with funding for the research provided by an anonymous donor who gifted a $1.5 million grant to the Scott and White Foundation. This $1.5 million grant remains in place specifically to fund this research, but the scope of the project has been expanded to accommodate the participation of noted oncologist Dr. Tyler Curiel at the UT Health Science Center, and to include the UT Health Science Center in both preclinical studies and organization of the P-IND protocol.

“We are very proud of Drs. Newell Rogers and Curiel, their teams, and this milestone accomplishment in the Company's growth plan. As we bring our R&D pipeline from the laboratory to the clinical environment, MDT will continue to be one of two foundations – the other being TPT – around which we believe we can create tremendous value for our shareholders,” said Haig Keledjian, Viral Genetics' President. “As important as this specific ovarian cancer study may be, it is important to note that it is just one step in a much larger planned research effort relating to MDT compounds as cancer therapies. While we have targeted ovarian cancer as our first indication, there are numerous other types of cancer we intend to study in the early stages of MDT research. There is much more to MDT than just cancer, and there is much more to Viral Genetics than just MDT. As a shareholder myself, I view this as one of multiple opportunities that help us move closer to licensing fees and revenues while potentially bringing relief to people suffering from debilitating illness.”

Ovarian cancer is a particularly deadly form of cancer afflicting approximately 25,000 women each year in the United States. Amongst women, it is the most lethal of the gynecological cancers and the fifth leading cause of cancer death. Viral Genetics and Scott and White Foundation are sponsoring the study that is taking place at the UTHSCSA Cancer Therapy and Research Center and at Scott and White Hospital. The primary endpoints of the study are expected to relate to safety, although efficacy will also be studied in secondary endpoints, and to reflect a dose-escalation design.

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. This builds on the Company’s recent submissions of pre-INDs for TPT-based Lyme Disease and HIV/AIDS therapies. A pre-IND meeting with the FDA has since been scheduled for the Lyme Disease submission, and the Company is also now working through the steps mandated by the FDA’s feedback from the HIV/AIDS pre-IND.