Cellectar Biosciences has rolled out new clinical trial data showing patients are responding well to one of its cancer therapies.
The drug development firm, which has roots in UW-Madison, recently announced 12-month follow-up results from Phase 2b of its CLOVER WaM clinical trial.
It’s evaluating the use of its Iopofosine I-131 drug, which targets tumor cells while limiting exposure to healthy tissues, in patients with certain forms of a rare blood cancer called Waldenström macroglobulinemia.
Among the 55 patients included in the trial, the overall response rate was 83.6% and the more substantial major response rate was 61.8%, achieving its “primary endpoint” or key result for demonstrating the effectiveness of the treatment.
The median duration of response was 17.8 months, achieving its secondary endpoint, while median progression-free survival for study participants was 13.5 months. Its disease control rate was 98.2%, indicating the percentage of cancer patients that responded to the treatment and have stable disease.
Cellectar President and CEO James Caruso says the follow-up data required by the FDA “ further strengthen the compelling clinical profile” of Iopofosine I-131.
“Importantly, the durability of response continues to improve over time … We remain committed to providing iopofosine I 131 to the thousands of patients who can benefit from treatment and plan to initiate our confirmatory study in [the] fourth quarter of this year,” he said in a statement.
Jarrod Longcor, the company’s chief operating officer, also points to findings for a subset of the clinical trial group showing “strong and consistent efficacy” for patients exposed to certain prior therapies.
He says these results and the findings for the overall study group “underscore iopofosine’s potential as a meaningful new treatment option” for cancer patients and differentiate it from other existing therapies.
“We believe this dataset meets key regulatory expectations for an accelerated approval submission and positions us well as we advance toward initiating our confirmatory study,” Longcor said.
The latest results come after the firm last month began enrolling patients in a clinical trial assessing a potential treatment for an aggressive form of breast cancer.
For more of the most relevant health care news, reports on groundbreaking research in Wisconsin, links to top stories and more, sign up today for the free daily Health Care Report from WisPolitics and WisBusiness.com.
Sign up here.
