INC signs on to help Provectus get its regulatory act together

Provectus Biopharmaceuticals ($PVCT), a biotech that has been stung by regulatory setbacks, has recruited INC Research to audit its data on two drug candidates, tasking the CRO with poring over its documents as it moves into late-stage development.

Under the agreement, INC's experts will take a look at the cancer treatment PV-10 and the dermatological candidate PH-10. In the first phase, the CRO will inventory Provectus' regulatory documents and evaluate its information management system, the biotech said, all the while generating a document request list. In the second phase, INC will further evaluate those documents, conducting on-site reviews and due diligence analysis, according to the company.

For Provectus, the third-party scrutiny comes as the company prepares to take PV-10 into a Phase III trial in melanoma. The biotech had hoped to secure the FDA's coveted breakthrough-therapy designation for its top prospect, but, in May, the agency declined its application and forced the company to rethink its regulatory strategy. In an uncommon move, Provectus chose to make that rejection public, and the news torpedoed the biotech's shares, sending it into penny stock territory.

But despite the setback, Provectus is committed to taking PV-10 all the way to market, CEO Craig Dees said, and INC will be instrumental in the effort.

"By retaining their services, we are endeavoring to ensure that the upcoming Phase III trial for PV-10 as a treatment for melanoma as well as the future tests of both PV-10 for other indications and for PH-10 to treat dermatological diseases proceed with all possible speed," Dees said in a statement. "Making sure that all the paperwork is available and in good order will smooth out the process."

Meanwhile, INC is undergoing some transformational work of its own. The North Carolina CRO is looking to go public, filing to make a $150 million Wall Street debut, following contemporaries like Quintiles ($Q), Catalent ($CTLT) and PRA.

- read the statement