Q BioMed announces publication of pre-clinical research showing superior safety and efficacy against current first line therapy of its drug candidate Uttroside-B for liver cancer

On July 26, 2022 Q BioMed, Inc. (OTCQB: QBIO) a commercial-stage biotechnology development company reported a new publication supporting the potential superior safety and efficacy of its Uttroside-B chemotherapeutic to treat liver cancer vs the current first line FDA approved drug (Press release, Q BioMed, JUL 26, 2022, View Source [SID1234616968]).

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Liver cancer incidence rates have more than tripled since 1980, while the death rates have more than doubled during this time. More than 800,000 people are diagnosed with this cancer each year throughout the world and it accounts for more than 700,000 deaths annually. Hepatocellular Carcinoma (HCC) constitutes 90% of all liver cancer incidences, worldwide.

According to Research and Markets, the Global Sorafenib Market was valued at USD 1.08 Billion in 2020 and is projected to reach USD 1.18 Billion by 2027, growing at a CAGR of 1.21% from 2020 to 2027.

We previously reported the remarkable potency of Uttroside-B (Utt-B), against liver cancer cells. Recently, the U.S. FDA approved Utt-B as an ‘orphan drug’ against HCC. The current study validates the superior efficacy of Utt-B over sorafenib, the first-line FDA approved treatment option against HCC liver cancer.

The therapeutic efficacies of Utt-B vs. sorafenib against HCC were compared in vitro, using various liver cancer cell lines and in vivo, utilizing mice bearing human xenografts. The data indicate that Utt-B shows superior anti-HCC efficacy over sorafenib. Our previous report demonstrated the pharmacological safety of Utt-B in Chang Liver, the normal immortalized hepatocytes, and in the acute and chronic toxicity murine models even at high concentrations. Here, data shows that higher concentrations of sorafenib cause severe toxicity in acute and chronic in vivo models, indicating that, apart from the superior therapeutic benefit over sorafenib, Utt-B is pharmacologically safer and the drug-induced undesirable effects can be substantially alleviated in the context of HCC chemotherapy. This study highlights the therapeutic supremacy of Utt-B over sorafenib, the widely administered FDA-approved anti-HCC drug.

Denis Corin, Q BioMed CEO said, "This is another very compelling result and adds weight to the promise of an effective therapeutic for a patient population that desperately needs better and more treatment options. Having successfully completed a very challenging synthesis program, we are now finalizing manufacturing for tox studies, IND and a clinical partnership."

In more detail, researchers demonstrated the superior anti-clonogenic potential and anti-proliferating efficacy of Utt-B against liver cancer cells, compared to sorafenib in vitro. The pro-apoptotic potential of Utt-B is evident from the enhanced cleavage of caspases and significant increase in the percentage of apoptotic cells in Utt-B-treated HCC cells in comparison with sorafenib. Xenograft studies in immunocompromised murine models of human HCC exhibited a significant reduction in tumor development, with negligible side effects, in Utt-B-treated animals, whereas sorafenib treated mice exhibited symptoms of severe toxicity.

Undesirable effects associated with sorafenib chemotherapy is an impending problem in HCC patients. The present study attests to our previous report that Utt-B is pharmacologically safe up to five times the IC50 dose in acute and sub-chronic toxicity models, while even the IC50 dose of sorafenib is toxic to immunocompromised mice, and elevated doses of sorafenib induce adverse effects such as breathing problems, signs of hypertrophy, and mild regenerative changes in liver hepatocytes, in normal immune competent mice.

The researchers highlight Utt-B as a promising anti-HCC drug, owing to its enhanced therapeutic efficacy and pharmacological safety over sorafenib, the first-line treatment option for HCC.

This innovation has been granted a patent from the US, Canada, Japan and South Korea and has been conferred ‘Orphan Drug’ status against HCC by the U.S. FDA.

The research has been led by Dr. Ruby John Anto, a senior investigator at Rajiv Gandhi Centre for Biotechnology (RGCB). Q BioMed has the exclusive license to the technology through an agreement with RGCB and the Oklahoma Medical Research Foundation.