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Provectus Biopharmaceuticals, Inc.

Drug Names(s): Provecta; Injectable Rose Bengal

Description: PV-10 is 10% rose bengal in saline.

Applied intralesionally, it can elicit selective chemoablation of solid tumors. Upon application of radiation, the drug can function as a radiosenstizer. Radiosensitizers enhance the safety and effectiveness of radiation treatment by increasing the effects of radiation on tumor tissue, and offer potential to treat patients using notably less radiation, thus limiting adverse side effects. Provectus' PV-10 has previously demonstrated the ability to make radiation-resistant melanomas in laboratory animals highly sensitive to radiation treatment.

The precise mechanism of action of PV-10 is not known, but may involve:

  • Untreated tumors exhibit high levelsof granulocytes (basophils, eosinophils and mast cells) in tissue surrounding tumors
  • PV-10 treatment results in increased levels of mononuclear tumor-infiltrating lymphocytes
  • Release of tumor antigens to local antigen-presenting cells may facilitate presentation of appropriate antigenic targets to T and B-cells
  • Collateral destruction of granulocytes surrounding the tumor may precipitate chemokine release and local inflammation, and could serve an adjuvant role in promoting specific anti-tumor response

Deal Structure: Provectus and Boehringer Ingelheim
In July 2015, Provectus signed a Letter of Intent (LOI) with Boehringer Ingelheim (China). The purpose of the LOI is to lay a foundation for the two parties to collaborate in bringing PV-10, Provectus' novel investigational drug for cancer (PV-10), to market in mainland China, Hong Kong and Taiwan.

Under the terms of the LOI, Boehringer will provide certain commercially reasonable support in the aspects of product registration with the China Food and Drug Administration (CFDA), communication preparation, market intelligence and other assistance to Provectus in China to the extent that is within Boehringer's approved business scope and permissible by Chinese laws. In return, Provectus will grant Boehringer the first priority to be the exclusive collaborator of Provectus in China for PV-10 in the event that PV-10 is successfully registered and approved by the CFDA.

Partners: Boehringer Ingelheim GmbH

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