Oncologix Tech, of Suwanee, GA, has suffered a setback in the development of its lead product, a radiation device for treating soft-tissue cancers. Recent testing has revealed that Oncologix’s Oncosphere System is releasing radiation at a higher rate than anticipated, a discovery that the company estimates will add $1 million to its projected development costs.
The Oncosphere System is based on radioactive microparticles designed to deliver therapeutic radiation directly to a tumor site by introducing the microparticles into the artery that feeds the tumor tissue.
What was uncovered in recent tests is something called “leaching,” which refers to the amount of radiation physically released from the microspheres that had been previously thought to be bound. The level of leaching was high enough that progress with the product will require further investigation into process and material modifications. Oncologix says it will have to replace at least one of Oncosphere’s constituent components.
Oncologix had previously estimated that it would cost about $5 million to complete pre-clinical testing and clinical approval of Oncosphere. Armed with this new information, the company has revised that estimate to $6 million. And, in a company statement, Oncologix said that any new development is dependent on the firm’s ability to raise additional funds from the proceeds of new loans or the sale of additional equity.
The news is a significant blow for the former long-distance phone company, which earlier this month announced internal changes that strengthened its commitment to medical technology and its lead product: It moved its corporate office to be closer to its R&D facility, where Oncosphere is being developed, reconfigured it’s board to create a greater presence of medical device expertise, and named a med tech exec to its CEO post.
But chief Andrew Green has his head up: “Our objective will be to continue to design, test, and provide medical products that meet the highest standards for safety and effectiveness,” said Green, in a press release. “We are optimistic about our new approach and believe that if successful, we will have a product that has expanded possibilities for diagnostic and therapeutic applications.”