Holy Stone Healthcare submitted an application to the US FDA for compassionate use of its new drug, CA102N, for the treatment of colorectal cancer, in phase I clinical trials.

24, Nov 2021

Holy Stone Healthcare’s new drug, CA102N, for the treatment of colorectal cancer is conducting phase I clinical trials in the US on patients with late-stage chemo-refractory mCRC. A patient’s condition is stabilizing after the treatment, and exceeding the original-planned 12 treatment cycles (336 days). With no worsening of their condition nor serious adverse effects, the patient intends to continue the treatment. However, with regards to the trial timeline for CA102N, as well as the fact that the clinical data collected is sufficient for primary analysis, the principal investigator, Dr. Dragovich, after discussing with CRO, has decided to end the phase I trial with the last patient completing their 15 treatment cycles. For ethical reasons, Holy Stone Healthcare submitted an application to the US FDA on Nov. 24, 2021, for compassionate use and expanded access for the patient, so they can continue receiving the treatment with the drugs from this clinical trial.


Holy Stone Healthcare is conducting its phase I clinical trials on dose escalation and dose expansion in 3 medical centers in the US: The University of Texas M. D. Anderson Cancer Center, Banner MD Anderson Cancer Center, and University of Colorado Cancer Center. Besides safety and tolerability studies, PK analysis data is also collected during the trials. Currently, the trials for all participants are completed, as well as the data collection. The study report and analysis are expected to be released in January 2021.


CA102N is a hyaluronic acid conjugated drug developed with the company’s Hyaluronan Drug Delivery (HDD) platform. CA102N is a targeted anti-cancer drug with multiple MOAs in inhibiting tumor growth, thus making it less likely to build drug resistance, comparing to traditional chemotherapy. CA102N, either administered alone or as a combination therapy with a current drug, has the potential to become the first-line treatment of colorectal cancer.


Colorectal cancer is one of the most common types of cancer in the world. It has the third-highest Incidence rate, just after breast cancer and lung cancer. The mortality of colorectal cancer is the second-highest, just after lung cancer. According to “Colorectal Cancer Drugs Global Market Report 2021: Covid 19 Impact And Recovery To 2030”, issued by The Business Research Company in June 2021, due to the COVID-19 pandemic, the global market of (colorectal cancer CRC) treatments in 2020 and 2021 dropped to USD 6.23 billion and USD 6.09 billion, respectfully. However, following the ease of the pandemic, the market is expected to grow gradually and reach USD 6.85 billion in 2025.

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