FDA Clearance of IND Application for FK-PC101, a Novel Personalized Cancer Immunotherapy for Prostate Cancer

[Maxone73]

FK-PC101, another step in the right direction it seems!

prnewswire.com/news-release...

[KocoPr]

This treatment could prevent patients from bio recurrence after prostatectomy. Won’t help us but may prevent a lot of future warriors.

The trial, CELLVX-230, is a randomized, multicenter, open-label study of irradiated autologous cellular vaccine in men with high-risk prostate cancer post-radical prostatectomy. It will be conducted through a partnership with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC), with Scott Eggener, MD (University of Chicago) as Principal Investigator. Patient recruitment will begin in March 2024, with a goal of up to 230 participants sourced from 21 pre-selected sites across the US. Theragent will be responsible for end-to-end manufacturing, release, and disposition of all clinical material out of its purpose-built, state-of-the-art CGMP cell therapy manufacturing facility in Arcadia, CA. "We are tremendously excited to partner with CellVax on this clinical trial. Theragent was founded specifically for this purpose – to bring paradigm-changing treatments to patients in need," said Dr. Yun Yen, President and CEO of Theragent.

Despite recent improvements in radiation, surgeries, and other therapies, up to 30% of patients may still experience recurrent prostate cancer after prostatectomy. After recurrence, the current standard of care is salvage radiotherapy and/or androgen deprivation therapy (ADT). FK-PC101 could delay the necessity for such treatments, if not prevent it entirely. The primary clinical endpoint for CELLVX-230 will be disease free survival (DFS), with the secondary endpoint being increased time to next treatment (TTNT).

[Maxone73 in reply to KocoPr]

yes...now...but they might test it in different settings and PC stages...I am always trying to identify working trends if their development platform is truly effective, it can help for other cancer types as well

[KocoPr in reply to Maxone73]

Good point! Just like using Pluvicto earlier.

[God_Loves_Me]

How can I get access ? I do not see clinicaltrials.gov even

[Maxone73 in reply to God_Loves_Me]

I will look into it tomorrow, but you can write to the company that is developing the molecule