LOS ANGELES, Aug. 23, 2016 /PRNewswire/ -- Immix Biopharma, Inc. is pleased to announce the successful completion of six-month stability testing for its lead and foundational candidate, Imx-110.
In stability studies, a drug's stability is tested under the influence of a variety of environmental factors such as: temperature, humidity and light. Data from these studies enable recommended storage conditions, retest intervals, and shelf lives to be established. These studies are an essential precursor to human studies, based on ICH and FDA guidelines.
Phase 1/2 studies for Imx-110 are planned to commence in late-2017. "Internally, the bar is set high for the upcoming clinical trial's primary and secondary outcomes. Our company is looking for an expected objective response rate between 60 and 85 percent. To our knowledge, this will be the first-ever study in humans combining a very small dose of a cytotoxin with a non-toxic sensitizing agent in the same delivery vehicle," shared Immix CEO and co-founder Dr. Ilya Rachman.
UCLA's Director of Bone Marrow/Stem Cell Transplantation and Professor of Hematology-Oncology, Dr. Gary Schiller, added "this has the potential to add an effective and safe treatment option for patients failing all otherwise-available agents." Dr. Schiller is an advisor to Immix and was also an investigator for Celator's nanotherapy candidate -- CPX-351. CPX-351's trial led to the company's recent $1.5B acquisition earlier this year, after showing a significant improvement in overall survival.
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Imx-110 holds the promise to become the first non-toxic, effective therapy in chemotherapy and immunotherapy-resistant patients. In preclinical studies, Immix' first-in-class candidate, Imx-110, induced cell death and improved survival in a variety of cancers. Imx-110 is a unique formulation combining less than 5% of the typical cytotoxic dose and a potent sensitizer co-loaded inside a nanosized delivery vehicle that is well suited for conjugation and tumor targeting.
Immix Biopharma, Inc. is a privately held, biopharmaceutical firm focused on developing safe and effective therapies for cancer patients. The team was founded by Vladimir Torchilin, Ph.D., D.Sc. Director of the Center for Pharmaceutical Biotechnology and Nanomedicine at Northeastern University and the former Head of Chemistry Program at Harvard Medical School and Massachusetts General Hospital; Ilya Rachman, an MD, PhD, MBA, physician scientist and clinical researcher; and Sean D. Senn, JD, MSc., MBA, a senior biotechnology patent attorney and fund manager.
SOURCE Immix Biopharma, Inc.