A promising new cancer treatment will begin a pivotal clinical trial thanks to a $2.05 million grant from the National Institutes of Health (NIH) and the National Cancer Institute (NCI). The therapy has been developed by Lamassu Bio Inc., a biotech company dedicated to creating innovative cancer therapies.
The new treatment involves taking an oral drug that could unleash a patient’s own healing power to destroy tumors without the need for invasive surgery, toxic chemotherapy, or radiation. The drug, called SA53, would target MDM2, a protein that deactivates the body’s natural defense mechanism called p53. It could be used alone, or in combination with other therapies to treat p53 wild-type sarcomas, which are malignant tumors of connective tissues, including some leukemias, lymphoma, prostate, and skin cancers.
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The upcoming clinical trial that will be conducted in collaboration the Cleveland Clinic will focus on achieving objectives such as determining a safe dosage for future trials and assessing early signs of effectiveness in treating soft tissue sarcomas with wild-type p53, the most frequently mutated gene in cancer. The main goal is to offer a potentially new and effective targeted treatment for patients, especially the 13,000 new patients suffering from sarcomas each year.
“We believe that this genetically targeted therapy is potentially game-changing and can bring new hope for thousands of patients dealing with these cancers,” says Dr. Gabi Hanna, the founder and CEO of Lamassu. “The NIH grant will play a pivotal role in facilitating the transition of our research from the laboratory to the bedside. Collaborating with a team at Cleveland Clinic and NCI will also help accelerate the advancement of this therapy to the next phase of development. Together, we’re poised to make meaningful strides in bringing innovative treatments to those in need who have no good options.”
Hanna tells Newsmax that SA53 stands for the “Selective Activator of p53.” It interferes with the action of MDM2, a protein that marks p53 for destruction, thus stopping the natural action of this tumor suppressor gene, also called the “guardian of the genome.” The gene is activated by cell stress including DNA damage and its job is to activate cellular pathways to either repair the cell damage or to destroy the cells.
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“This serves as the critical checkpoint to prevent the transformation of normal cells into cancer,” says Hanna. “If p53 can be activated in cells that have already become cancerous, p53 can either halt the cell from further division and growth, or it can activate programmed cell death to kill the cell and shrink the tumor.”
So far, the treatment has demonstrated remarkable potency, efficacy and safety in preclinical models. The Food and Drug Administration recently approved the upcoming trials for the SA53-MDM2 therapy under the Investigational New Drug program.
“We are looking forward to investigating how this drug could work to possibly teach cancer cells how to die in a variety of cancers,” says Dr. Peter Anderson, an oncologist at Cleveland Clinic and principal investigator of the upcoming study.
Lynn C. Allison ✉
Lynn C. Allison, a Newsmax health reporter, is an award-winning medical journalist and author of more than 30 self-help books.
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