Oral cancer. Squamous cell carcinoma histopathology. (Source: Wikimedia/KGH)The Ohio State University and the University of Michigan have signed an exclusive worldwide agreement with Ohio-based Venture Therapeutics Inc., to form a new company to develop and commercialize a pharmaceutical technology targeted for the treatment of precancerous oral lesions. These lesions are currently managed by invasive surgery and approximately a third of these lesions will reoccur after surgery.
Previously published data shows that about 30% of the higher grade precancerous oral lesions progress to oral cancer, specifically oral squamous cell carcinoma. This type of cancer is particularly devastating to patients because treatment entails removal of facial and mouth structures essential for esthetics and function. The National Cancer Institute estimates that 42,440 Americans will be diagnosed with oral cancer and over 8,390 oral cancer related deaths will occur in 2014.
The pharmaceutical technology developed by researchers at The Ohio State University (OSU) College of Dentistry with secondary appointments at the OSU Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) and the University of Michigan addresses a significant unmet need related to the prevention of oral cancer. Precancerous oral lesions can be seen and touched by patients, so this easy access to the lesion allows the use of local delivery formulations in an oral patch to directly treat the disease without causing adverse side effects.
“This type of collaboration, involving multiple university partners with strong industry support, is increasingly essential to expedite the discovery, development and delivery of more targeted cancer therapies. There is no routine cancer, and today it takes the collective minds across disciplines, institutions and industry to move the field forward,” said Michael Caligiuri, director of The Ohio State University Comprehensive Cancer Center and chief executive officer of the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute.
“Ultimately, these collaborations can be the catalyst for new, more effective cancer treatments, leading to better outcomes, faster responses, fewer side effects and more hope for cancer patients everywhere,” said Caligiuri.
These technologies were developed by a team of university-based researchers who work extensively with the affected patient population and actively explore new drug delivery methods such as the oral patch.
Susan Mallery, professor and interim chair of the division of oral pathology and radiology at the Ohio State 
College of Dentistry and member of the OSUCCC – James Molecular Carcinogenesis/Chemoprevention Research Program, worked alongside Steve Schwendeman, Ara G. Paul Professor and chair of the Department of Pharmaceutical Sciences, professor of Biomedical Engineering, at the Biointerfaces Institute, University of Michigan, and his former assistant research scientist, Kashappa Goud Desai, to invent this breakthrough technology. 
“The oral patch sidesteps any toxicity issues, which have historically been a problem with conventional treatments,” said Mallery. “This technology delivers an excellent chemopreventive compound directly to the precancerous tissues.”
"Dr. Mallery and I have collaborated for years on translational research projects,” said Schwendeman.  “It is very gratifying to see our efforts progress past the preclinical state and into clinical trials where we can directly help patients.”
The College of Dentistry at Ohio State saw great things for the collaboration between the two universities. “Having two College of Dentistry faculty members from Ohio State engage with researchers from the University of Michigan resulted in a very innovative approach that will dramatically improve patient care and outcomes,” said Dean Patrick Lloyd, College of Dentistry. “Conducting the clinical trials for this innovation at Ohio State’s College of Dentistry is very promising for the technology and prospective patients, and beneficial to both universities on a national level.”
Ohio State, through the Ohio State Innovation Foundation and the university’s Drug Development Institute, and the University of Michigan licensed the intellectual property to the newly formed Sirona Therapeutics.
In this unique business model, Ohio State and Venture Therapeutics will work together throughout the entire drug development process, including commercialization of the technology. Venture Therapeutics will be responsible for the drug development activities including formulation development, clinical trial batch manufacture, clinical trial and bio-analytical activities and regulatory affairs. Ohio State will provide assistance with transfer of intellectual property, clinical trials, and recruitment of patients, patient biopsies, surgical suites, and pharmacokinetic analysis.
“This agreement with Venture Therapeutics and the creation of Sirona Therapeutics is a great example of a collaboration that provides long-term value for the university, central Ohio, and patients,” said Tim Wright, vice president of Technology Commercialization and founder of the Drug Development Institute at Ohio State.  “This agreement is in alignment with one of the university’s research priorities, health and wellness, with the ultimate goal of moving this technology through commercialization thereby improving lives.”
Venture Therapeutics, with offices and laboratories in Columbus and New Albany, was co-founded by Peter Stoelzle and Michael Medors, who have more than 50 years of combined experience in the pharmaceutical industry. This alliance will allow continued faculty participation in the advancement of the technology, as well as integration of core university facilities during the next phase of human clinical trials.
“The management team of Venture Therapeutics has proven experience in quickly and efficiently delivering critical care therapeutics to commercial markets. These skill sets are complementary to Ohio State’s proficiency in the discovery and clinical development of human therapeutics,” said Stoelzle.
“Collaboration will be efficient, given that both Venture Therapeutics and the university are located in the Central Ohio area. This can help compress development timelines and enable patients more rapid access to the technology,” said Stoelzle.
Date: June 4, 2014