Actinium Pharmaceuticals Inc (NYSEMKT: ATNM)
Actinium Pharmaceuticals has been hinting toward increasing its development pipeline during the past few months, and on Tuesday, ATNM delivered on that initiative.
ATNM will be expanding its clinical development pipeline, initiating a phase I trial to evaluate Actimab-M in treating patients with multiple myeloma who are unresponsive to currently available options. The trial was initiated at Texas Oncology- Baylor Charles A. Sammons Cancer Center in Dallas, Texas, and will be conducted by Principal Investigator and Trial Sponsor, Dr. Yair Levy.
This phase I trial compliments the two current trials that are already being advanced by ATNM, a pivotal phase III trial that includes Iomab-B to prepare patients for bone marrow transplants, and its phase II trial evaluating Actimab-A and its therapeutic value in treating patients with newly diagnosed AML.
Acimab-M phase I trial
Actimab-M is comprised of the anti-CD33 monoclonal antibody HuM-195 coupled to actinium 225, an alpha particle emitting radioisotope, the same construct being evaluated in the company’s phase II trial to treat patients with newly diagnosed AML, who are over the age of 60.
CD33 is an antigen found on hematopoietic cells in certain blood cancers, and is commonly associated with myeloid malignancies including acute myeloid leukemia. However, recent research has shown that CD33 can also be found on malignant cells of approximately 25%-35% of all multiple myeloma patients. In addition, the expression of this marker has been shown to increase in relapsed and refractory myeloma, and is a predictor for a very aggressive course of disease.
This predictive quality makes CD33 a potential target for the treatment of multiple myeloma, an often fatal disease. While the disease is treatable, multiple myeloma is currently not curable and almost all patients eventually relapse or become refractory to currently available treatments as their condition progresses.
In this new ATNM trial, Actimab-M will be used in patients who have progressing disease after 3 prior multiple myeloma treatment regimens or are refractory to QUAD (Caflizomib, Lenalidomide, Pomalidomide, Dexamethason).
“I am very excited to lead in the development of this novel and promising approach,” said Dr. M. Yair Levy of Texas Oncology – Baylor Charles A. Sammons Cancer Center. “Relapsed and refractory multiple myeloma is an area of high unmet medical need that we hope to address with Actimab-M. Myeloma is a very radiosensitive cancer, and does not present with the neutropenia and thrombocytopenia of AML. I would expect tolerability of this treatment to be better in this disease. Based on my previous experience with Actimab-A in AML and my research in the area of multiple myeloma, I believe that this targeted treatment could prove efficacious and be a part of our growing armamentarium against this disease.”
The phase I trial for Actimab-M is a multi-center, open label, dose escalation study, with patients receiving an increased dose of Actimab-M via infusion on day one of each cycle for up to eight cycles that will lasting 42 days. The dosage increases will be increased once deemed safe and tolerable in patients, and will evaluate the maximum dose tolerated, assess adverse events, measure response rates, and evaluate progressive free survival and overall survival rates.
ATNM In 2017
The year 2017 should shape up to be a strong year, potentially transformative for ATNM. Investors can expect updates from all three current clinical trials, the potential for a fourth trial to begin prior to year end, and will benefit from a much fortified balance sheet that has the means to propel company initiatives through 2017.
Sandesh Seth, Executive Chairman of Actinium Pharmaceuticals provided an optimistic tone for the company’s new trial when he said, “We are incredibly excited to see the initiation of this trial for Actimab-M in multiple myeloma. Not only does this mark the beginning of the expansion of our clinical pipeline beyond AML, it also demonstrates the broad applicability of our radioimmunotherapy technologies that we intend to progress into new indications and patient populations. Further, this reinforces Actinium’s commitment to developing therapies for patients with unmet needs. We look forward to providing updates as this trial progresses.”
Stay focused to CNA Finance for additional ATNM updates as they break.
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