FDA approves a new IND application of 225Ac-J591 (Actinium)

[Maxone73]

The FDA has granted clearance to an investigational new drug (IND) application for 225Ac-J591 (CONV01-α), a prostate-specific membrane antigen-targeted monoclonal antibody under investigation for the treatment of patients with advanced prostate cancer, announced Convergent Therapeutics, the developer of the therapy, in a news release.

225Ac-J591 demonstrated safety and preliminary efficacy across all dose levels in predominantly 177Lu-naïve patients with metastatic castration-resistant prostate cancer (mCRPC).

Specifically, among the patients who were evaluable for a prostate-specific antigen (PSA) change (n = 22), 21 patients (95%) in the study experienced a PSA decline. Of these, 14 (67%) patients experienced a decline of at least 50%, and 6 (27%) experienced a decline of at least 90%.

urologytimes.com/view/fda-c...

[lcfcpolo]

This is excellent news. Hopefully it is rolled out quickly, both stateside and in Europe. I think that the Australians are already ahead of the game.

[KocoPr]

from your link. This is great news!

“this new IND will allow us to rapidly advance CONV01-α into phase 3 studies and expand the scope of clinical development of CONV01-α as a monotherapy and in combination with other cancer therapies."

[Scout4answers]

One of our members Mateo Beach aka Paul went to Australia 2 years ago to get this therapy.