On August 3, 2016 Cellectar Biosciences, Inc. (Nasdaq: CLRB) ("the company"), an oncology-focused biotechnology company, reported that it has received the second phase of a National Cancer Institute ("NCI") Fast-Track Small Business Innovation Research ("SBIR") contract award in the amount of $2 million to support funding of a Phase 2 clinical study of the company’s lead product candidate, CLR 131, for the potential treatment of hematologic malignancies, including multiple myeloma (Filing, 8-K, Cellectar Biosciences, AUG 9, 2016, View Source [SID:1234514436]).
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"The NCI SBIR contract is important to Cellectar in a variety of ways, ranging from the opportunity to receive non-dilutive funding that will significantly support a Phase 2 clinical study of our lead product candidate, CLR 131, to further advance our understanding of the potential clinical utility of CLR 131 in additional hematologic malignancies with high unmet medical needs, as well as providing further validation of the benefits of our Phospholipid Drug Conjugate (PDC) development program, " said Jim Caruso, president and CEO of Cellectar Biosciences. "Previous studies have demonstrated that hematologic malignancies are highly sensitive to radiotherapeutics. We anticipate observing the unique clinical benefits iodine–131, a cytotoxic radioisotope, may provide in combination with our cancer-selective delivery vehicle. We are also extremely pleased to be continuing our collaboration with the NCI’s SBIR program, which plays a vital role in the development of novel therapeutics."
The first phase of the NCI SBIR contract was focused on the pre-clinical development of CLR 125. However, following a comprehensive data review and product development and commercialization analysis, the company determined that the superior strategic approach would be to redeploy the contract to CLR 131, its lead product candidate. Following a review of all the data, both the NCI and the company determined that the second phase of the contract would be optimized through a multi-center, open label, study of CLR 131 in patients with hematologic malignancies.