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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

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Q BioMed, Inc. (QBIO) announced the publication of preclinical research in Pharmaceuticals demonstrating that its chemotherapeutic agent Uttroside-B (Utt-B) shows superior efficacy and safety compared to sorafenib, the current FDA-approved treatment for hepatocellular carcinoma (HCC). The research, backed by FDA's orphan drug designation, indicates that Utt-B has a significantly lower toxicity profile and effectively reduces tumor growth in HCC models. The findings may pave the way for better treatment options for liver cancer patients in need.

Positive
  • Uttroside-B shows superior efficacy over sorafenib in treating HCC.
  • FDA granted Uttroside-B orphan drug status for HCC.
  • Uttroside-B exhibited a significantly lower toxicity profile compared to sorafenib.
Negative
  • None.

Publication in Pharmaceuticals in May 2022 is titled Augmented Efficacy of Uttroside-B over Sorafenib in a Murine Model of Human Hepatocellular Carcinoma

NEW YORK, July 26, 2022 /PRNewswire/ -- Q BioMed, Inc. (OTCQB: QBIO) a commercial-stage biotechnology development company announces 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.

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.

Please visit www.QBioMed.com for more information on our various pipeline products.

About Q BioMed Inc.

Q BioMed Inc. (Q) is a commercial-stage biomedical acceleration and development company. We are focused on licensing and acquiring biomedical assets across the healthcare spectrum. Q is dedicated to providing these target assets the strategic resources, developmental support, and expansion capital they need to ensure they meet their developmental potential, enabling them to provide products to patients in need‏.

About Oklahoma Medical Research Foundation

OMRF (omrf.org) is an independent, nonprofit biomedical research institute dedicated to understanding and developing more effective treatments for human diseases. Its scientists focus on such critical research areas as cancer, diseases of aging, lupus and cardiovascular disease.

About The Rajiv Gandhi Centre for Biotechnology 

RGCB is an autonomous national institution fully owned by the Government of India. It does pioneering research in cellular and molecular mechanisms of human, animal and plant disease by amalgamating theory, modeling, simulation, and experimental science.

Forward-Looking Statements

This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

Contact:
Denis Corin, CEO
Q BioMed Inc.
+1 888 357 2435

Investor Relations:
Keith Pinder
+1(404) 995-6671
ir@qbiomed.com 

Cision View original content:https://www.prnewswire.com/news-releases/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-301593225.html

SOURCE Q BioMed, Inc.

FAQ

What are the findings of Q BioMed's study on Uttroside-B for liver cancer?

Q BioMed's study found that Uttroside-B is more effective and safer than sorafenib in treating liver cancer, with superior anti-cancer efficacy and a lower toxicity profile.

When was the research on Uttroside-B published?

The research was published in May 2022.

What is the significance of Uttroside-B's orphan drug status?

The orphan drug status indicates regulatory support for Uttroside-B, highlighting its potential for treating a serious condition with limited treatment options.

How does Uttroside-B compare to sorafenib based on the study?

The study shows that Uttroside-B has enhanced therapeutic efficacy and a significantly reduced risk of toxicity compared to sorafenib.

What is the market potential for Uttroside-B?

With liver cancer cases rising and sorafenib's market projected to grow slowly, Uttroside-B may capture significant market share due to its improved efficacy and safety.

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