Provectus (PVCT) Could See More PV-10 Results and Regulatory Path Clarity in Early Q2
Provectus Pharmaceuticals, Inc. (PVCT), which is developing cancer drugs in the same market as companies like Dendreon Corporation (DNDN) and Genta Incorporated (GETA), could see some regulatory clarity on the horizon as the FDA reviews its PV-10 drug.
Provectus Pharmaceuticals, Inc. (PVCT), a pharmaceutical company focused on developing cancer and psoriasis treatments using the Rose Bengal compound could see some regulatory clarity on the horizon as its PV-10 drug nears the end of its Phase 2 clinical trial.
The cancer treatment can elicit selective ablation of solid tumors and an apparent bystander response in untreated lesions. In Phase 1 studies, a single injection led to an objective response in 40% of subjects and locoregional disease control in 75% of subjects. Phase 2 results are even better.
Moreover, Provectus’ drug was well tolerated with one notable Grade 3 adverse event and modest transient pain at the treatment site followed by local inflammation or infection in some patients. It is this solid safety profile that has led to the drug’s quick progression through its clinical trials.
The company’s PV-10 treatment for metastatic melanoma is seeking an accelerated path with the FDA, which could provide clarity in the early part of the second quarter. Meanwhile, the company is also continuing to assess PV-10’s chemoablation of liver and breast cancers.
In its latest ASCO presentation, Provectus’ data showed that the immune system responses provoked by the treatment are real, and more world-class scientists are looking to learn more about it. Here is a clip from its ASCO Presentation in 2009 showing robust efficacy:
Thanks to these results, the FDA has already given Provectus a green light for a compassionate use program. The tightly controlled program enables medical professionals to use the PV-10 treatment on seriously ill patients, oftentimes when no other suitable treatments are available.
The company’s PV-10 drug has already proven to be an effective treatment for cancer in that it selectively targets harmful cancer cells and forces them to undergo chemoablation (cell death), according to data published in its nearly completed Phase 2 trial.
Thus far, the Phase 2 trial showed an objective response in 60% of patients with locoregional disease control in 75% of patients. Meanwhile, the response of untreated bystander lesions was also consistent with observations in Phase 1 trials, which bodes even better for the treatment.
In the end, investors are looking forward to some near-term results from the robust PV-10 clinical trials that could help move the stock. Meanwhile, the positive results from the Phase 1 and 2 clinical trials suggest a high probability of success.
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