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Posted On: 08/15/2022 11:42:39 PM
Post# of 148899
With regard to colorectal cancer, chazzledazzle said some good RTT results were rolled into the basket trial. Ohm20 noted that the FDA cleared a Phase 2 study in 2019. I found the follow on EDGAR.
From the 1/8/21 10-Q:
Phase 2 Trial for Metastatic Colorectal Cancer
In early September 2019, the FDA granted clearance to proceed with Phase 2 studies of leronlimab and regorafenib as a combination therapy for metastatic colorectal cancer. This Phase 2 study will enroll 30 patients and is designed to test the hypothesis that the combination of leronlimab, administered as a subcutaneous injection, and regorafenib, administered orally, will increase progression-free survival in patients with CCR5-positive metastatic colorectal cancer. We have not initiated this trial because metastatic colorectal cancer patients can also enroll in the Phase 2 basket trial.
From the 7/30/21 10-K:
Basket Trial for 22 Solid Tumor Cancers
This is a Phase 2 trial to test the safety and efficacy of leronlimab on 22 different solid tumor cancers, including brain-glioblastoma, melanoma, lung, breast, ovarian, pancreas, bladder, throat, stomach, colon, testicular, uterine, among other indications. The first patient was treated in April 2020. Nine patients either reached one year or surpassed one year of treatment with leronlimab. The trial will conclude in 2021. A planned trial relating to colorectal cancer was combined into this trial.
From the 10-K today (section on strategies, page 5)
4. Contining our Phase 2 program for metastatic triple-negative breast cancer with current standard of care, explore a Phase 2 colon cancer trial with current standard of care, and explore other solid tumor indications.
It appears colon cancer is becoming an area of emphasis. This aligns with chazzle's post about RTT patients having good results.
From the 1/8/21 10-Q:
Phase 2 Trial for Metastatic Colorectal Cancer
In early September 2019, the FDA granted clearance to proceed with Phase 2 studies of leronlimab and regorafenib as a combination therapy for metastatic colorectal cancer. This Phase 2 study will enroll 30 patients and is designed to test the hypothesis that the combination of leronlimab, administered as a subcutaneous injection, and regorafenib, administered orally, will increase progression-free survival in patients with CCR5-positive metastatic colorectal cancer. We have not initiated this trial because metastatic colorectal cancer patients can also enroll in the Phase 2 basket trial.
From the 7/30/21 10-K:
Basket Trial for 22 Solid Tumor Cancers
This is a Phase 2 trial to test the safety and efficacy of leronlimab on 22 different solid tumor cancers, including brain-glioblastoma, melanoma, lung, breast, ovarian, pancreas, bladder, throat, stomach, colon, testicular, uterine, among other indications. The first patient was treated in April 2020. Nine patients either reached one year or surpassed one year of treatment with leronlimab. The trial will conclude in 2021. A planned trial relating to colorectal cancer was combined into this trial.
From the 10-K today (section on strategies, page 5)
4. Contining our Phase 2 program for metastatic triple-negative breast cancer with current standard of care, explore a Phase 2 colon cancer trial with current standard of care, and explore other solid tumor indications.
It appears colon cancer is becoming an area of emphasis. This aligns with chazzle's post about RTT patients having good results.
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