St. Luke’s University Health Network Cancer Trial Shows Results with PV-10

Aug 5, 2019 | Melanoma, PV-10, St. Luke’s University Health Network

St. Luke’s University Health Network Cancer Trial Shows Results with PV-10

St. Luke’s University Health Network reports positive results with Provectus Biopharmacueticals’ PV-10 investigational treatment as “the tumors simply shriveled up and flaked off.”

Background of PV-10

St. Luke’s University Health Network in Pennsylvania is conducting a study on behalf of commercial sponsor Provectus Biopharmaceuticals. PV-10 causes acute oncolytic destruction of injected tumors, releasing damage associated molecular pattern molecules (DAMPs) and tumor antigens that initiate an immunologic cascade where local response by the innate immune system facilitates systemic anti-tumor immunity by the adaptive immune system. The DAMP release-mediated adaptive immune response activates lymphocytes, including CD8+ T cells, CD4+ T cells, and NKT cells, based on clinical and preclinical experience in multiple tumor types. T cell function can be further augmented by combining PV-10 with immune checkpoint inhibition.

PV-10 is undergoing clinical study for adult solid tumor cancers such as melanoma and cancers of the liver and preclinical study for pediatric cancers like neuroblastoma, Ewing sarcoma, rhabdomyosarcoma and osteosarcoma. The FDA has granted PV-10 Orphan Status. PV-10 is protected by a handful of U.S. patents.

The Study

St. Luke’s University Health Network is one of a number of research sites participating in the international multicenter, open-label, sequential phase study of intralesional (IL) PV-10 in combination with immune checkpoint inhibition. Metastatic melanoma patients (Stage IV or Stage III unresectable, in-transit or satellite disease) with at least one injectable lesion who are candidates for pembrolizumab (both treatment naïve patients and treatment refractory patients who have failed to achieve a complete or partial response to or previously progressed on one or more checkpoint inhibitor) will be eligible for study participation. In the Phase 1b portion of the study, all participants will receive the combination of IL PV-10 and pembrolizumab (i.e., PV-10 + standard of care). In the subsequent Phase 2 portion of the study, participants will be randomized 1:1 to receive either the combination of IL PV-10 and pembrolizumab or pembrolizumab alone (i.e., PV-10 + standard of care vs. standard of care).

Exciting Progress for James McCandless

Bethlehem, PA, resident James McCandless enrolled in this study last year reported the Saucon Source local news. Fair-skinned and 81, McCandless has struggled with skin cancer and is participating in the study for stage IV melanoma on his liver with the FDA approved drug Keytruda. After cancerous moles were found on his scalp, he was treated with PV-10, the Rose Bengal derivative over several months. They found that shortly after each injection “the moles shrank, dried out and flaked off, leaving slight scars in their place.”  James’ wife Violet declared “they worked wonders.”

The results were so good St. Luke’s recently updated the American Society of Clinical Oncology (ASCO) annual meeting in Chicago. They noted the promising impact and few side effects.

The Sponsor

The study’s commercial sponsor is Provectus Biopharmaceuticals. They have been around for nearly two decades and develop advanced therapies designed to target and destroy the deadliest cancers—melanoma, liver and breast—while eliminating side effects. They are a micro-cap stock trading at 68 cents per share. They lost about $6 million last year and according to Yahoo Finance have secured about $1.8 million in the bank.

Lead Research/Investigator (For St. Luke’s)

Dr. Gary Lu 

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