A compound used for years as a diagnostic agent for liver and eye cancer is nearing phase 3 clinical trials for a different purpose: to treat cancers and dermatological conditions.
Provectus Pharmaceuticals Inc. (OTC BB:PVCT) is developing formulations of Rose Bengal that have made it through phase 2 trials in melanoma, atopic dermatitis and psoriasis. One of its formulations, PV-10 for cancer, is being prepared for a phase 3 trial.
Provectus said last week in a U.S. Securities and Exchange Commission filing that it had raised $2 million in equity and options, warrants or other rights, with the potential to continue raising up to $5 million. An executive from the company wasn’t available to comment, but a recent news release estimates the trial will begin late this year or early next, involve 180 subjects with stage III melanoma, and last 30 months. According to a recently updated fact sheet, the company has enough cash on hand to support its operations through 2013.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Although the Knoxville, Tennessee company doesn’t elaborate much on its immunotherapy’s mechanism of action, it says PV-10 is injected into lesions to selectively target and destroy cancer without harming healthy tissue. In phase 2 trials, it demonstrated a 51 percent objective response rate and was especially potent in stage III patients. The U.S. Food and Drug Administration has granted the compound orphan drug designation for melanoma and liver cancer indications.
In the liver cancer application and an additional breast cancer application, the drug has been through successful phase 1 trials.
Phase 2 trials of the company’s dermatological drug, PH-10, have been completed in atopic dermatitis and psoriasis, and Provectus says it will seek a licensing partner to co-develop the drug from here on out.
Revenue generated from the malignant melanoma drug market is poised to expand seven-fold over the next decade, according to research firm Decision Resources, driven by new treatment options like Bristol-Myers Squibb’s Yervoy and Roche/Genentech Zelboraf. But, as with other immunotherapies, costliness compared to potential benefits could be an inhibitor to adoption. GlaxoSmithKline also has a melanoma drug in late-stage development.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
[Photo from Flickr user Christiana Care]
