'Attainment of complete CNS clearance in a patient with Bing-Neel Syndrome after previous exposure to BTKi therapy is encouraging,' commented
As part of the CLOVER WaM pivotal trial, the patient with BNS received the standard WM dosing regimen of two treatment cycles with two doses per cycle for a total of four fixed doses of iopofosine I 131 over 75 days. The patient received the recommended total administered dose of greater than 60mCi. Cerebrospinal fluid flow cytometry showed no evidence of clonal B-cells, and molecular analysis did not detect the MYD88 mutation.
'This confirmed pathologic response with iopofosine I 131 in a malignancy with CNS involvement further validates the potential of our phospholipid radiotherapeutic conjugate to treat CNS malignancies,' said Dr.
Cellectar previously announced a complete response in a patient with relapsed/refractory primary central nervous system lymphoma (CNSL) as part of its ongoing Phase 2a trial of iopofosine I 131. Currently, there are no approved therapies available to CNSL patients.
Additionally, with the support of a
About
The company's product pipeline includes lead asset iopofosine I 131, a small-molecule PDC designed to provide targeted delivery of iodine-131 (radioisotope), proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets.
About Waldenstrom's Macroglobulinemia and Bing-Neel Syndrome
WM is a B-cell malignancy characterized by bone marrow infiltration of clonal lymphoplasmacytic cells that produce a monoclonal immunoglobulin M (IgM) that remains incurable with available treatments. The prevalence in the US is approximately 26,000 with 1,500-1,900 patients being diagnosed annually. Approximately 10,000 patients require treatment in the relapsed or refractory setting and there are an estimated 4,300 patients requiring 3rd line or greater therapy. There are no FDA approved treatment options for patients progressing on BTKi therapy. BTKi therapies do not demonstrate complete response rates and require continuous treatment. Approximately 50% of 3rd line patients not receiving treatment are likely to consider new treatment options. There is an established unmet need for new FDA approved treatments that provide a novel mechanism of action, increased deep durable responses, and time limited treatment, especially in heavily pretreated WM patients.
Bing-Neel Syndrome is a rare neurological complication of WM that results from infiltration of the central nervous system by malignant lymphoplasmacytic cells. The median time from initial diagnosis of WM to development of BNS is 3.5 years.
Forward-Looking Statement Disclaimer
This news release contains forward-looking statements. You can identify these statements by our use of words such as 'may,' 'expect,' 'believe,' 'anticipate,' 'intend,' 'could,' 'estimate,' 'continue,' 'plans,' or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes including our expectations regarding the WM CLOVER-WaM pivotal trial. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the disruptions at our sole source supplier of iopofosine, the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, patient enrollment and the completion of clinical studies, the FDA review process and other government regulation, our ability to maintain orphan drug designation in
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