Ohio State University (OSU) and the University of Michigan have signed an exclusive, global agreement with Ohio-based Venture Therapeutics to form a new company to develop and commercialize a pharmaceutical technology targeted for treating precancerous oral lesions.
Susan R. Mallery, DDS, PhD, a professor and the interim chair of the division of oral pathology and radiology at the OSU College of Dentistry and a member of the OSU Comprehensive Cancer Center-James' Molecular Carcinogenesis and Chemoprevention research program, was part of a research team that invented the technology.
"The oral patch sidesteps any toxicity issues, which have historically been a problem with conventional treatments," Dr. Mallery stated in a press release. "This technology delivers an excellent chemopreventive compound directly to the precancerous tissues."
These lesions are currently managed by invasive surgery, and approximately a third of these lesions will reoccur after surgery, according to OSU.
Studies show 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 aesthetics and function.
The National Cancer Institute estimates that 42,440 Americans will be diagnosed with oral cancer, resulting in more than 8,390 oral cancer-related deaths in 2014.
The pharmaceutical technology, developed by researchers at the OSU College of Dentistry with secondary appointments at the OSU Comprehensive Cancer Center -- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute and also 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 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," stated Michael Caligiuri, MD, director of the OSU Comprehensive Cancer Center and CEO of the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, in a press release.
"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," Dr. Caligiuri said.
The technologies were developed by a team of university-based researchers who work with the affected patient population and explore new drug delivery methods such as the oral patch.
"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, DDS, dean of the OSU 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," he said.
Partnership formed
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, OSU and Venture Therapeutics will work together throughout the entire drug development process, including commercialization of the technology.
Venture Therapeutics will be responsible for drug development activities, including formulation development, clinical trial batch manufacture, clinical trial and bioanalytical activities, and regulatory affairs. OSU will provide assistance with transfer of intellectual property, clinical trials and recruitment of patients, patient biopsies, surgical suites, and pharmacokinetic analysis.
Venture Therapeutics, which has offices and laboratories in Columbus and New Albany, said the 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.
