The American FDA has granted Fast Track Designation to the company’s drug candidate, RV001.
Fast Track Designation is granted to investigational drugs for expedited review by the FDA, to facilitate development of drugs aimed at treating serious or life-threatening conditions and fill unmet medical needs.
The granted Fast Track Designation means that Rhovac and RV001 are eligible for more frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval, more frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers, eligibility for Accelerated Approval and Priority Review, provided relevant criteria are met and rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
Phase IIb clinical trial
The drug candidate is currently engaged in a phase IIb clinical trial in prostate cancer, a study that aims to recruit more than 175 patients and that involves centres both in Europe and in the US. The study aims to conclude in the beginning of 2022. In prostate cancer there is currently no other therapy available for patients to prevent cancer recurrence. Currently, these patients undergo only surveillance and have no access to preventive therapy. Only when patients are diagnosed with recurring and now metastatic cancer, are they again eligible for therapy such as hormone therapy. The aim of RV001 development is to ensure that fewer patients will have to experience recurring cancer and that progression is delayed in those that do. If a Proof of Concept (PoC) for the use of RV001 in prostate cancer is obtained, it is highly likely that the drug will also be tried in other cancer forms, as there is nothing prostate specific about the scientific rationale for the drug candidate per se.
“We are extremely pleased and proud that our drug candidate, RV001, has earned Fast Track Designation by the FDA. We obviously appreciate the benefits that this might entail in terms of access to FDA advice and an accelerated approval process. But also the fact that the FDA has reviewed our data, and found our drug candidate worthy of this level of priority, obviously sends a clear signal of recognition of the drug’s potential to all our would-be partners, which is something of great importance to us,” says RhoVac’s CEO, Anders Månsson.
Photo of Anders Månsson: RhoVac
