Leading diagnostics company will offer ultra-sensitive tumor cell detection technology CMx TM to enable treatment selection and real- time monitoring of treatment response in patients with early stage cancer.
January 2, 2019 – Sunnyvale, CA – CellMax Life, a diagnostics company focused on colorectal cancer, has been named as a partner in Medigen Biotech’s upcoming cell therapy clinical trials. Medigen Biotech, a global biotech company developing cell therapies for cancer treatment, will use CellMax Life’s circulating tumor cell platform CMxTM, in combination with its comprehensive liquid biopsy panel to assess treatment selection and response.
Immune cells are cells in the body’s immune system that are responsible for combating foreign pathogens and removing tumors or damaged tissues from the body. Natural killer (NK) cells are the body’s first line of defense against cancer. Medigen Biotech is able to culture NK cells, without the use of genetically modified substances, to effectively increase the number and purity of NK cells, increasing their toxic ability to kill cancer cells.
The planned open-label, multi-center, single arm clinical trial is expected to enroll patients with Stage II and III colorectal cancer that has been surgically resected, or surgically resected and treated with chemotherapy. For the phase I trial, expected to initiate in 2019, patients who test positive on the CellMax Life blood test will receive the NK cell therapy. This trial is designed to monitor patients multiple times during the course of treatment, using the CellMax blood test, to assess treatment response.
CellMax Life’s proprietary blood test uniquely isolates and analyzes both circulating tumor cells and circulating tumor DNA from a single sample of blood for the assessment of six types of analytes including four classes of genomic alterations, micro-satellite instability and circulating tumor cells.
“For this clinical trial, we needed a non-invasive blood test that can be used to screen for initial treatment selection, but also used multiple times during the course of treatment to monitor patients,” Dr. Stanley Chang, Chairman and CEO of Medigen Biotech said in a statement. “Because we expect to recruit patients with early stage cancer, test sensitivity was the key criteria for platform selection. We were very impressed with the sensitivity of the CellMax Life circulating tumor cell platform CMx for the detection of colorectal cancer presented at ASCO’s gastrointestinal symposium. By combining the CMx assay with the CellMax ctDNA based liquid biopsy, which is comparable to the best-in-class ctDNA liquid biopsies in performance, we hope to have the most sensitive test for treatment selection and monitoring response.”
“Colorectal cancer is the second deadliest cancer in the U.S., with 150,000 new cases and $14 billon spent on treatment annually,” said Atul Sharan, Co- Founder and CEO of CellMax Life. “Medigen’s vision to develop innovative cancer therapies especially for the earlier stages of cancer when it is most treatable, is very much aligned to CellMax Life’s mission to reduce mortality from colorectal cancer. We are pleased that the coming clinical trial would bring benefits to colorectal cancer patients.”
About CellMax Life
CellMax Life is focused on colorectal cancer prevention with a simple and accurate blood test for the detection of pre-cancer and colorectal cancer. The company is conducting a study with leading U.S. medical centers including Stanford Medicine and the U.S. Department of Veterans Affairs Palo Alto Health Care System, Johns Hopkins and University of Southern California to seek FDA-approval for this test. CellMax Life is headquartered in Sunnyvale, CA. For more information, visit https://cellmaxlife.com.
About Medigen Biotech
Medigen Biotech is a biopharmaceutical company focused on novel cell therapy technology and new drug development for cancer treatment. The company has now developed into a biomedical group with business fields also covering molecular diagnosis, cell-based vaccine technology, biologics and ophthalmic drug manufacturing. For more information, visit http://www.medigen.com.tw/en/home/