<0> First Patient Enrolled for Dual-Site Physician-IND Study at The Cancer Therapy and Research Center of the University of Texas Health Sciences Center at San Antonio and Scott and White Hospital </0>
Viral Genetics Begins Phase 1 Clinical Trial for Ovarian Cancer
<0> Viral Genetics, Inc.Haig KeledjianT: (626) 334-5310 </0>
The first patient has now been enrolled into the Phase 1 clinical trial sponsored by Viral Genetics’ (OTC Pink: VRAL) and supported by a donation from Scott and White Foundation. The trial will study Metabolic Disruption Technology (MDT) compounds in combination with an existing cancer therapy to treat drug-resistant ovarian cancer. A total of up to 24 patients will receive combination treatment of hydroxychloroquine and sorafenib (marketed as Nexavar™) under primary investigator, Tyler Curiel, M.D., MPH, a medical oncologist affiliated with The Cancer Therapy and Research Center (CTRC) of The University of Texas Health Science Center at San Antonio. This clinical trial is the first sponsored by Viral Genetics based on the licensed research of Dr. M. Karen Newell-Rogers, the Company’s Chief Scientist, and represents a milestone in the transition of the Company from preclinical- to clinical-stage. Patient enrollment is also expected to commence at Scott and White Hospital as soon as internal review procedures there are finalized.
“Patient enrollment marks the formal beginning of a clinical trial and so we are quite happy to get underway after much preparation and hard work by our team members, and Dr. Curiel’s group,” said Haig Keledjian, President of Viral Genetics. “I want to emphasize that we would not have proceeded with this choice of one MDT compound if we and our advisors were not confident that it held real promise for patients, but one should also appreciate the severity of the illnesses we are attempting to treat in this study. We advise optimistic but cautious and restrained expectations.”
Because of the staggered nature of patient enrollment which calls for a few patients to be enrolled and treated at low doses prior to enrolling additional patients at higher doses, full enrollment of the study could take up to a few months. Follow up and patient observation will continue post-treatment for up to 12 months. The study can be stopped at any time for safety reasons.
Title: “A Phase I Dose-Escalation Trial of Oral Hydroxychloroquine Plus Oral Sorafenib to Treat Epithelial Ovarian Cancer FIGO Stage III or Stage IV, or Extraovarian Peritoneal Carcinoma, or Fallopian Tube Carcinoma Failing or Ineligible for First-Line Therapy” (HSO1)
The HSO1 study will examine the safety and efficacy of one of the MDT compounds, hydroxychloroquine (HCQ), in combination with an existing cancer drug, sorafenib (marketed as Nexavar™) in the treatment of resistant or otherwise untreatable Stage III or IV ovarian cancer including related carcinomas. Viral Genetics is sponsoring the HSO1 study, which is taking place at the Cancer Therapy and Research Center and, eventually at Scott and White Hospital system.
The primary endpoints of the HSO1 study are related to safety and reflect the dose-escalation design of the trial, which is intended to find a maximum tolerated dose of different combinations of HCQ and sorafenib in patients while being alert to any potential toxicities. The study can be stopped in the event of significant adverse events, including toxicity. Both HCQ and sorafenib have separately been extensively studied in humans for safety and toxicity, and they have fairly well-understood individual safety profiles. This will be the first study to examine them in combination using the MDT research suggesting that such a dual-pronged approach would significantly enhance results of single agents alone.
Efficacy will also be evaluated through secondary endpoints in three ways: “objective tumor responses” (defined under the global “Response Evaluation Criteria in Solid Tumors” standard), “progression-free survival”, and certain immune system blood markers. A positive response would generally be characterized by shrinkage in tumor, lesion, or lymph nodes and/or patient survival without advancement of their existing cancer. Additional signs of efficacy include improvement or normalization in certain blood markers (including CA-125 and immunological tests) that are linked to successful treatment responses in ovarian cancer, although this would not generally be considered as a successful outcome on its own without other improvements as well.
There will be up to four separate groups or “cohorts” in the HSO1 study, each of which will have up to 6 patients. Each cohort will be given a combination of doses of HCQ and sorafenib over a treatment cycle of 28 days. Presuming low levels of toxicity following dosing, additional patients will be added and higher doses of the combination will be given. Depending on the outcome of the primary, and to a lesser extent, secondary endpoints, the study will enroll between 2 and 24 patients in total. Treatment will generally continue for as long as toxicity results remain within acceptable limits and patients experience clinical benefit. Results will be available throughout the course of each 28 day cycle, and will be reviewed by a Data Safety Monitoring Board.
Ovarian cancer is a particularly deadly form of the disease afflicting approximately 20,000 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.
San Marino, California-based Viral Genetics discovers drug therapies from two platform technologies based on over 60 patents: Metabolic Disruption (MDT) and Targeted Peptides (TPT). Founded in 1994, the biotech company is researching treatments for HIV/AIDS, Lyme Disease, Strep, Staph and drug resistant cancer. A majority-owned subsidiary, VG Energy (), is dedicated to exploring biofuel and agricultural applications for the MDT platform. For more information, visit .
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This news release contains forward-looking statements that involve risks and uncertainties associated with financial projections, budgets, milestone timelines, clinical development, regulatory approvals, and other risks described by Viral Genetics, Inc. from time to time in its periodic reports, including statements about its VG Energy, Inc. subsidiary. None of Viral Genetics' drug compounds are approved by the US Food and Drug Administration or by any comparable regulatory agencies elsewhere in the world, nor are any non-pharmaceutical products of VG Energy, Inc. commercialized. While Viral Genetics believes that the forward-looking statements and underlying assumptions reasonable, any of the assumptions could be inaccurate, including, but not limited to, the ability of Viral Genetics to establish the efficacy of any of its drug therapies in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of those drug compounds in the United States, the obtaining of funding required to carry out the development plan, the completion of studies and tests on time or at all, the successful outcome of such studies or tests, or the successful commercialization of VG Energy, Inc.’s non-pharmaceutical products. Therefore, there can be no assurance that the forward-looking statements included in this release will prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the forward-looking statements should not be regarded as a representation by Viral Genetics or any other person that the objectives and plans of Viral Genetics will be achieved.