Update: New Melanoma Drug Shows Promise In Trial

Editor’s note: Yesterday, Provectus shares traded at 86 cents and moved significantly upwards based on this post. Please keep in mind that investing in “penny stocks” that trade for less that a dollar a share is very risky and outsized share price movements can be triggered by relatively insignificant news.

A new cancer drug benefited 51% of stage III and IV melanoma patients during a phase II trial, achieving complete response (total cancer disappearance) in 26% during the treatment period. That was all in just 16 weeks of treatment, suggesting this drug has great potential for treating certain cancers in the future.

During the study, which was published yesterday in the journal Annals of Surgical Oncology, PV-10 (a small molecule ablative agent) was injected directly into the lesions of 62 patients with stage III melanoma and 18 patients with stage IV melanoma, up to four times during a 16-week period. 51% of the patients, Americans and Australians who had tried a median of six interventions before this, had a response. For about half of that 51%, the response was partial (at least 30% cancer removed), and for the other 26%, the response was complete. For patients who had all of their disease treated (28 were able to have this done), 50% ended the 16-week treatment period with no sign of disease. The drug even shrank cancerous lesions in areas not directly treated, achieving a response in 33% of untreated bystander lesions for the 42 patients analyzed specifically for that. In a large majority of patients, the side effects occurred only at the site, were mild to moderate and didn’t go beyond temporary pain.

Following the 16-week treatment period, researchers observed patients for 36 weeks, not treating their cancer. The cancer recurred in many patients who had a complete response during the treatment period, which is the nature of refractory cutaneous and subcutaneous metastatic melanoma. Still, at the end of the 52 weeks, 8% of patients displayed no evidence of cancer, suggesting the drug can produce efficient results.

“When the drug was injected in all of the patient’s disease, response tended to be both rapid and dramatic, with a high rate of complete response,” said Dr. Eric Wachter, director of the study and CTO of Provectus Biopharmaceuticals, Inc., the company that engineered PV-10. “The patients may have benefited from more drug in some cases [of recurrence and partial response]. However, we need to prove that in phase III.”

The main limitation of the study, which had a team of mostly medical doctors not previously affiliated with Provectus, was its restrictions. Researchers were limited to a total of 20 lesions treated per patient and only had three retreatment opportunities, none after 16 weeks, which explains why only 28 patients were able to have all of their cancerous lesions treated. These limitations will go away in phase III, which is targeted to open near the end of the year.

Provectus, a public company (NYSE MKT:PVCT) founded in 2002 and based in Knoxville, Tenn., had similar rates of partial and complete response in the phase I trial of PV-10 in melanoma patients, and continues to test the drug in patients with metastatic liver cancer and recurrent breast cancer, with varying results. Provectus is also in phase I and II trials with its drug PH-10 for patients with atopic dermatitis and psoriasis. A common characteristic in each of these trials, with both drugs, is safety of use.

But as with any cancer drug, the bigger goal is effectiveness, which many melanoma patients, though not experiencing painful symptoms necessarily, need. Melanoma is the most serious type of skin cancer and has around a 24% 10-year survival rate in the last phase of stage III and 10-15% in stage IV. Spreading to lymph nodes and internal organs is more common in melanoma cases than any other type of skin cancer. The chance of recurrence varies by stage and the nature of the cancer, but is especially persistent in locally advanced cutaneous melanoma, the subjects of this study.

If PV-10, when injected in all the cancerous lesions of a melanoma patient for longer than 16 weeks, goes on to produce positive results in the next phase, it just may be a viable treatment option for many patients with aggressive, late-stage, locally advanced melanoma. And perhaps other cancer patients as well, according to Dr. Sanjiv S. Agarwala, one of the lead MDs of the study and a professor of medicine at Temple University.

“Anything you can reach with a needle is something we can try,” Agarwala said. “I think it will be an option for many patients who have a cancer disease that’s localized or regional. I don’t know if it will replace other treatments, but it can be another option for certain patients.”

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