Provectus Biopharmaceuticals said today it will partner with The Pediatric Oncology Experimental Therapeutics Investigators Consortium (POETIC) to study the company’s Phase III ablative immunotherapy candidate PV-10 as a potential treatment for childhood cancers.

Provectus and the consortium have signed a joint research agreement establishing a framework for collaborative preclinical research projects the company may conduct with members of POETIC, a group of 10 top-tier academic medical centers developing new pediatric cancer therapies.

The value of the research agreement was not disclosed. Provectus and POETIC did say, however, that their research program will collaborate with “a number of” NCI Cancer Centers that are part of the consortium, citing by name Memorial Sloan Kettering Cancer Center (MSK) and Alberta Children’s Hospital.

PV-10 is an injectable formulation of Rose Bengal that is being studied as an ablative immunotherapy for solid-tumor cancers. Provectus has received FDA orphan drug designations for PV-10 covering melanoma and hepatocellular carcinoma indications.

According to Provectus’ website, PV-10 has completed a Phase I trial for breast cancer, has finished recruiting for a Phase I study to detect immune cell infiltration into melanomas treated with PV-10, and is in another Phase I study for neuroendocrine tumor (NET) cancer. The company is also in a Phase Ib/II study of a combination PV-10 and Merck & Co.’s Keytruda® (pembrolizumab) in melanoma and is planning a Phase Ib/II trial of PV-10 alone for cancers of the liver.

Furthest along of the clinical studies is Provectus’ Phase III trial of PV-10 for locally advanced cutaneous melanoma.

“While we remain firmly committed to that core program, this collaboration allows us to team up with top researchers in pediatric oncology to comprehensively assess whether PV-10 has additional potential for pediatric cancers,” Provectus CTO Eric Wachter, Ph.D., said in a statement.

“If this proves successful, we look forward to working with POETIC to move promising indications from the lab to the clinic as quickly as possible, building upon our experience with adult cancers to make this happen,” Dr. Wachter added.

POETIC promotes early clinical development of promising therapies for treating children, adolescents, and young adults with cancer and related disorders. The consortium was founded in February 2003 by Lia Gore, M.D., at the University of Colorado Cancer Center and Tanya Trippett, M.D., at Memorial Sloan Kettering Cancer Center.

MSK and Alberta Children’s Hospital are among POETIC’s 10 member institutions, as are Arkansas Children’s Hospital, Little Rock; Arnold Palmer Hospital for Children/MD Anderson Cancer Center Orlando; Dana-Farber/Children's Hospital Cancer Center; and MD Anderson Cancer Center.

Also members of the consortium are Lucile Salter Packard Children's Hospital, Stanford; Penn State Hershey Children's Hospital; Phoenix Children's Hospital; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; and University of Texas Health Science Center.








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