Actinium Pharmaceuticals, Inc. ATNM announced that the first patient has begun treatment in the third and final cohort of an investigator-led phase I study, evaluating a combination of Actimab-A with a chemotherapy regimen, CLAG-M.
This phase I study is being conducted in patients with relapsed or refractory acute myeloid leukemia (AML). Actimab-A is an antibody radiation conjugate (ARC). Actinium's lead application for ARCs is targeted conditioning, which is intended to selectively deplete a patient's disease or cancer cells and certain immune cells prior to a bone marrow transplant, gene therapy or adoptive cell therapy.
The study is being conducted at the Medical College of Wisconsin. The objectives of the study are to evaluate the safety, determine the maximum tolerated dose and response rates, progression-free survival, and overall survival. The overall response has been 86% so far, better than other approaches.
Patients in the third cohort will receive a chemotherapy cycle of CLAG-M (cladribine, cytarabine, G-CSF, and mitoxantrone), followed by 0.75 uCi/kg dose of Actimab-A on Day 6, 7 or 8. The cohort should be completed bymid-2020.
Shares of the company have slumped 50% in the past year compared with the industry’s decline of 7.6%.
The AML patients in the study have been at high risk with intermediate and poor-risk cytogenetics, with most of them having received three or more prior therapies, including bone marrow transplant. Patients in the first cohort received 0.25 uCi/kg of Actimab-A and the second cohort received 0.50 uCi/kg of Actimab-A.
In the study, the second cohort with CLAG-M plus the sub-therapeutic 0.5 uCi/kg dose showed that 86% of patients achieved complete remission (CR/CRi). This represents about 60% increase over the remission rate reported in a study of seventy-four patients with relapsed or refractory AML, who received CLAG-M alone. Further, 71% of patients achieved negative minimal residual disease (MRD) status following treatment with the combination. This means that these patients had no detectable disease after treatment.
Preliminary remission rates achieved with Actimab-A combined with CLAG-M compare favorably with targeted agents recently approved for patients with relapsed or refractory AML.
The data supports the company’s hypothesis that improved outcomes can be achieved with an ARC therapy in combination with chemotherapy.
If the phase I study is a success, Actinium plans to advance this combination to a phase II, randomized study to demonstrate further significance.
Actinium Pharmaceuticals, Inc. Price
Actinium Pharmaceuticals, Inc. price | Actinium Pharmaceuticals, Inc. Quote
Zacks Rank & Stocks to Consider
Actinium currently carries a Zacks Rank #3 (Hold).
A few better-ranked stocks in the healthcare sector are Novan Inc. NOVN, Redhill Biopharma Ltd. RDHL and Grifols S.A GRFS, all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Novan’s loss per share estimates have narrowed from $1.05 to 52 cents for 2020 and from 84 cents to 27 cents for 2021 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters by 34.23%, on average.
Redhill’s loss per share estimates have narrowed from 20 cents to 5 cents for 2021 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters by 18.75%, on average.
Grilfols’ earnings per share estimates have increased from $1.16 to $1.19 for 2019 and from $1.30 to $1.42 for 2020 in the past 60 days.
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