Purdue Researcher Helps Secure FDA Approval…Again
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For the second time in less than six months, cancer-focused medical innovation based on work by Purdue University researcher Dr. Philip Low has received approval from the U.S. Food and Drug Administration. The new precision treatment is used on patients with advanced prostate cancer, one of the most common cancers among American men. In a Phase III study, the targeted treatment along with the normal standard of care had a 38% reduction in the risk of death compared with the standard of care alone.
In an interview with Inside INdiana Business, Low said the FDA gave the treatment higher classification.
“After demonstrating a remarkable benefit to prostate cancer patients, the FDA actually assigned it breakthrough status, which is unusual,” said Low, the Ralph C. Corley Distinguished Professor of Chemistry in the Purdue University College of Science. “And then after that, they ushered it through the approval process as quickly as possible. And now it’s available.”
The technology will now be marketed through Switzerland-based Novartis Inc., which in 2018 acquired Low’s biopharmaceutical company Endocyte in a $2 billion deal.
Low says this treatment gives certain prostate cancer patients with advanced cases new hope when there are no other options.
“Metastatic castration resistant prostate cancer is a late stage of the cancer that no longer responds to essentially any drug. When they [FDA] saw that this actually reduced the probability of mortality and improved progression free survival, and the quality of life of these patients, they recognize that this was a significant benefit to this population and elected to move it forward rapidly and make it available.”
In November, the FDA approved a new imaging drug called Cytalux that was also developed by Low. The innovation helps to assist surgeons in identifying ovarian cancer lesions during surgery with the use of fluorescent technology. That technology is marketed by West Lafayette-based On Target Laboratories Inc.
After his initial research, Low disclosed it to the Purdue Research Foundation Office of Technology Commercialization.
“The Office of Technology Commercialization receives over 400 invention disclosures from researchers each year and licenses over 200 technologies annually. We continue to search for commercialization partners for these technologies and work closely with them to support their efforts to translate the technology to the market to improve the world,” said Brooke Beier, senior vice president of commercialization at the Purdue Research Foundation.
The icon of Indiana’s life sciences sector says he’s proud of both and would not rank one accomplishment over the other.
Looking ahead, Low says the same Cytalux fluorescent dye technology used in spotting ovarian cancer tumors is also being tested for prostate cancer. He says it is currently in Phase II clinical trials and will hopefully and eventually get FDA approval.
“I just feel blessed to have had an opportunity to work on meaningful projects throughout my career and even more blessed to have had an impact on one unnecessary source of pain and morbidity,” Low said. “I suspect that almost everyone knows someone who has suffered with prostate cancer, and it has been very rewarding to finally be able to impact this horrible disease.”