How AlloStim works
AlloStim comprises certain immune system cells derived from the blood of healthy donors that are intentionally incompatible with a patient’s own cells to produce large amounts of danger signals for the body.
These danger signals promote the patient’s immune system to recognize AlloStim cells as foreign and recruit more immune cells to the location of the tumor to eliminate the AlloStim cells and also disrupt the tumor’s ability to avoid an immune attack.
Using this method, researchers hope the patient’s immune system cells will not only reject the AlloStim cells but also kill the tumor cells.
AlloStim in clinical trials
The safety and anti-tumor activity of AlloStim were evaluated in a two Phase 1/2 clinical trials (NCT00861107 and NCT00558675), which took place in the U.S. and Israel, in patients with metastatic cancer and advanced hematological malignancies (cancers that affect the blood and lymph system). Although the studies were completed in 2011 and 2013, no results or updates have been published yet.
AlloStim is now being evaluated as a combination therapy in four other clinical trials.
A Phase 2/3 study (NCT01741038) was designed to determine the safety and efficacy of AlloStim in combination with cryoablation, a method used to kill cancer cells with extreme cold, in patients with metastatic colorectal cancer. In the trial, the cryoablation of a part of the tumor will allow the release of tumor-specific markers that can be recognized by the immune system while the injection of AlloStim into the lesion will prompt the immune response to kill the tumor cells. The study, which will take place in Thailand, is not yet open for participant recruitment.
The same therapeutic combination is being used to determine the safety and anti-tumor effect of increased doses of AlloStim in patients with metastatic colorectal cancer who do not respond to chemotherapy. The Phase 2 clinical trial (NCT02380443), now underway in the U.S., has already dosed its first patients and is still open for recruitment.
An open-label, single-site Phase 2 clinical trial (NCT02409524) is currently recruiting patients to investigate the safety and efficacy of AlloStim in combination with chaperone-rich cell lysate (CRCL) for advanced liver cell carcinoma, after a minimum of 90 days of Nexavar (sorafenib) treatment. The study is currently recruiting participants in Thailand.
Finally, a Phase 2 trial (NCT02624999) is comparing AlloStim plus CRCL to cisplatin chemotherapy in recurrent/metastatic squamous cell carcinoma of the head and neck. The trial is expected to enroll 100 patients at the National Cancer Institute of Thailand but is not yet open for participant recruitment.
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