Under the agreement, MedGenesis will receive an undisclosed, upfront option fee and upon exercise of the option by Pfizer, will be eligible for further milestone and royalty payments. MedGenesis is currently running a proof of concept study in Parkinson's disease with its GDNF and CED technology.
“The terms of the agreement with Pfizer are confidential,” Greg Johnson, chairman and CFO of MedGenesis told BioPharma-Reporter.com.
GDNF was discovered in 1991 by researchers at Synergen, a biotech company based in Boulder, Colorado. In early studies, GDNF revived dishes of dying neurons and when tested in monkeys with an induced form of Parkinson's disease, the treated monkeys trembled and spasmed less than their untreated cage mates, according to Nature.
Previous animal model and open label Parkinson’s disease patient investigations showed that continuous glial cell line-derived neurotrophic factor (GDNF) infusions improved “motor symptoms and, as assessed by brain scans and post-mortem assessments, restore dopamine nerves,” according to the ongoing study.
However, a placebo-controlled multi-centre trial at the beginning of the last decade failed to demonstrate clinical benefit. In addition, a study in monkeys raised questions over safety, and further human investigations were not performed.
“In significant part, we believe, the above issues were due to a failure in the way GDNF was surgically delivered,” MedGenesis says in its research summary. “We have now developed an inhouse device which animal model studies suggest will allow GDNF to be given much more reliably to the putamen area of the brain. We feel that this now allows for definitive testing of GDNFs effects in humans. We propose conducting a placebo controlled trial of intermittent GDNF infusions in 42 patients at our centre. We anticipate that the information gained from this study, if successful, will rapidly lead to a large multinational trial with the prospect of a new disease-slowing therapy being available to PD patients within 5 years.”
CED technology is used to help pharmacological agents that would not normally cross the blood brain barrier to be used for treatment, according to a study in the Expert Review of Neurotherapeutics. When compared with other local drug delivery techniques, such as conventional injection or implantation of drug-containing polymers, CED provides for much wider, more consistent, and more homogenous drug distribution, and longer drug exposure across the target tissue, according to MedGenesis.
Erich Mohr, CEO and Chairman of MedGenesis, said, "We believe that delivering drugs, including proteins, precisely to the regions of the brain where they are required will allow the potential for better treatments for a whole range of central nervous system (CNS) disease, and opens up the opportunity for the potential development of truly disease-modifying treatments of neurological diseases."
"Pfizer is committed to improving the lives of people living with neurological diseases, including Parkinson's disease," said Michael Ehlers, SVP, Neuroscience Research Unit, Pfizer. "With limited treatment options currently available, Parkinson's disease is a devastating illness for patients and families. We believe that this collaboration with MedGenesis has the potential to provide the first disease-modifying treatment that slows the progressive decline in patients, consistent with our commitment to making a difference in areas of high unmet medical need."
PharmaVentures acted as an advisor to MedGenesis in the agreement.