MONTREAL, April 19, 2021 (GLOBE NEWSWIRE) — Sunshine Biopharma Inc. (OTC PINK: “SBFM”), a pharmaceutical company focused on the research, development and commercialization of oncology and antiviral drugs, today announced that it has successfully completed a Maximum Tolerated Dose (MTD) study in mice. Sunshine Biopharma is pleased to report that the MTD results are favorable and fall within the optimum range for use in humans. Next, Sunshine Biopharma will use the test dose indicated by these results to conduct the efficacy studies in hACE2-transgenic mice.
Sunshine Biopharma’s COVID-19 treatment is an inhibitor of PLpro, a protease present only in the SARS Coronaviruses (Betacoronaviruses) and is an important antiviral target as it is involved in shutting down the host innate immune system thereby causing significantly greater morbidity.
“MTD is defined as the highest dose of a drug that does not cause unacceptable side effects or overt toxicity in a specific period of time. The MTD studies we conducted were designed with a minimum number of animals and included endpoints such as clinical observations and blood tests for liver function,” said Dr. Steve Slilaty, CEO of Sunshine Biopharma. “We are delighted that our compounds passed this critical toxicology step with flying colors,” he added.
About Sunshine Biopharma’s Coronavirus Treatment
Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) is the causative agent of the ongoing COVID-19 pandemic that has claimed the lives of over 3 million people worldwide since it first appeared in December 2019. There are currently no drugs that can effectively arrest replication of the virus in people who have contracted the illness. On May 22, 2020, Sunshine Biopharma filed a patent application for several molecules which were designed to inhibit the Coronavirus PLpro protease, thus shutting down the ability of the virus to multiply. PLpro is present only in the SARS Coronaviruses (Betacoronaviruses) and is an important antiviral target as it is involved in shutting down the host innate immune system. On February 1, 2021, Sunshine Biopharma entered into an exclusive license agreement with the University of Georgia for two additional Anti-Coronavirus compounds which the University of Georgia had previously developed and patented. Sunshine Biopharma is currently advancing the development of these two compounds in parallel with the Company’s own (SBFM-PL4) by conducting a transgenic mice study in collaboration with the University of Georgia. The goal of the ongoing study is to determine if our protease inhibitors will protect the hACE2-transgenic mice from disease progression and death following infection with SARS-CoV-2. Should these mice studies prove successful, Sunshine Biopharma plans to submit the results to the FDA and Health Canada for authorization to conduct testing on actual COVID-19 patient volunteers in a Phase I clinical trial setting.
About Sunshine Biopharma’s Anticancer Compound
In addition, to working on the development of a treatment for COVID-19, Sunshine Biopharma is engaged in the development Adva-27a, a unique anticancer compound. Tests conducted to date have demonstrated the effectiveness of Adva-27a at destroying Multidrug Resistant Cancer Cells, including Pancreatic Cancer cells, Small-Cell Lung Cancer cells, Breast Cancer cells, and Uterine Sarcoma cells. Clinical trials for Pancreatic Cancer indication are planned to be conducted at McGill University’s Jewish General Hospital in Montreal, Canada. Sunshine Biopharma is owner of all patents and intellectual property pertaining to Adva-27a.
Safe Harbor Forward-Looking Statements
This press release may contain forward looking statements which are based on current expectations, forecasts, and assumptions that involve risks as well as uncertainties that could cause actual outcomes and results to differ materially from those anticipated or expected, including statements related to the amount and timing of expected revenues statements related to our financial performance, expected income, distributions, and future growth for upcoming quarterly and annual periods. These risks and uncertainties are further defined in filings and reports by the Company with the U.S. Securities and Exchange Commission (SEC). Actual results and the timing of certain events could differ materially from those projected in or contemplated by the forward-looking statements due to a number of factors detailed from time to time in our filings with the SEC. Among other matters, the Company may not be able to sustain growth or achieve profitability based upon many factors including but not limited to general stock market conditions. Reference is hereby made to cautionary statements set forth in the Company’s most recent SEC filings. We have incurred and will continue to incur significant expenses in our expansion of our existing as well as new service lines noting there is no assurance that we will generate enough revenues to offset those costs in both the near and long term. Additional service offerings may expose us to additional legal and regulatory costs and unknown exposure(s) based upon the various geopolitical locations we will be providing services in, the impact of which cannot be predicted at this time.
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