On August 12, 2021 A Buffalo-based biotechnology company reported that it has received a $2.2 million federal grant to begin clinical trials on a treatment for brain cancer using light therapy (Press release, Photolitec, AUG 12, 2021, View Source [SID1234587063]).
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Photolitec LLC, which spun off from Roswell Park Comprehensive Cancer Center in 2010, received the three-year grant from the National Institutes for Health through the Small Business Innovation Research (SBIR) program, along with approvals from the Food & Drug Administration to begin phase one human trials.
The trials will allow the company to use its Photobac compound in combination with photodynamic therapy (PDT) to treat glioblastoma, a type of brain cancer.
This next step in the drug development process follows orphan drug status approval for Photobac by the FDA in late 2017; and an initial SBIR grant of $1.9 million awarded earlier that year.
Ravindra Pandey, founder and chief scientific officer, is director of pharmaceutical chemistry at Roswell Park and first developed the compounds there in his lab. They were later licensed back to the company and have been further developed in collaboration with global partners AMI-Organics in India and HISUN Pharma in China.
With no approved treatments yet for these types of brain tumors and the recurrence rates, the orphan drug status will definitely help speed up the process, Pandey said. The process helps surgeons be more precise in attacking tumors with better specificity, he said.
"No treatment works except PDT and this compound can treat tumors not only with the margins that you want, but deep-seated tumors. So the chances are we’ll have a much better response," he said.
Scott Friedman, general counsel at Photolitec and chairman at Lippes Mathias Wexler Friedman LLP, said though the process is taking longer than initially projected, the company is making great progress.
"Ravi is continuing to make great progress," he said. "There are hoops that early-stage companies without necessarily hundreds of millions or billions of dollars are being asked to jump through, so it’s a challenging environment to succeed in and it does occasionally take more time than might be expected. But I believe great companies figure out how to move forward."
Though PDT is not new, Photolitec’s approach applies light to a photosensitizer, which destroys tumor cells when combined with the oxygen present in the cancer. The company’s Photobac allows for deeper penetration into the tumor, which also limits the impact on surrounding tissue and reduces long-term skin phototoxicity.
Plans call for submitting clinical protocols to Roswell Park’s review board for approval, with a goal of beginning trials soon thereafter. Pandey is hopeful that process will be hastened with the FDA approval already in hand.
"Generally what happens is we send it for IRB first and then FDA but in this case it was the other way around," he said. "We hope that will make it faster. We already have the drug formulations and we’re all ready to go."
Pandey said the new funding from NIH, plus a score of "outstanding" on the research by peer reviewers also helps boost the chances the drug will attract lots of attention from big pharma when it comes time to manufacture and market Photobac. Whether investors will keep manufacturing here in Western New York is another question.
"We’re waiting on phase one data first, and that could take a couple of years," he said.