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Posted On: 02/18/2020 10:55:29 AM
Post# of 72440
From email received...........
“Defensins are conceptually ideal for defense against different viral infections.”
Over the last few weeks, the Company has received inquiries asking about Brilacidin’s potential to treat the Coronavirus given the urgent worldwide need to find effective treatments for this deadly epidemic.
Coronavirus (now being referred to as “COVID-19”) continues to represent a significant life-threatening risk in China and throughout the world, with currently over 71,000 diagnosed cases across 29 countries, resulting in nearly 1,800 reported deaths. The containment of the COVID-19 outbreak is far from a certainty, as expressed by Prof Gabriel Leung, the Chair of Public Health Medicine at Hong Kong University, warning that the epidemic could spread to 60% of the world’s population if not controlled.
We have long discussed the broad therapeutic spectrum for our defensin mimetic franchise and are pleased to inform shareholders that we are now engaged in talks with leading institutions and researchers regarding the opportunity to explore developing Brilacidin, our lead defensin mimetic drug candidate. Interactions center on assessing Brilacidin as a potential novel antiviral therapy for treating Coronaviruses, including COVID-19 and potentially Middle East respiratory syndrome coronavirus (MERS-CoV) and severe acute respiratory syndrome coronavirus (SARS-CoV).
Some of the brightest minds in the field of virology see the therapeutic potential of defensins and defensin mimetics in helping to address unexpected epidemics, as detailed by Mee Sook Park, et al in a 2018 review article, linked to below:
Towards the Application of Human Defensins as Antivirals
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5933891/
“Due to the relative nonspecificity of the targets of defensins compared to those of the adaptive arm, antiviral applications of defensins are conceptually ideal for defense against different viral infections.”
Despite outbreaks of zoonotic coronaviruses (those that jumped from animals to humans) like COVID-19, MERS-Cov and SARS-CoV�cumulatively rresponsible for thousands of deaths� scientists have been challengeed to develop effective treatments given the latest current threat usually subsides before a drug or vaccine can be adequately tested for safety and efficacy.
To that point, there is a movement within academia and regulatory bodies towards testing the antiviral potential of late-phase and approved drugs. These drugs have more established pharmacodynamic and pharmacokinetic profiles, thereby offering the opportunity to greatly shorten the development timeframe should they prove beneficial in treating coronaviruses.
This is exactly where Brilacidin fits in into the emerging Coronavirus threat�a promising small molecule in late-phase development worthy off further evaluation as to its antiviral properties.
Brilacidin already has demonstrated broad and robust antibacterial, anti-inflammatory and immunomodulatory properties in multiple FDA clinical trials. Pre-clinical research also supports Brilacidin’s antiviral properties based on work by conducted by Dr. William DeGrado (UCSF) and Dr. Richard Scott (Fox Chase).
Brilacidin and other defensin mimetics similar in structure to Brilacidin have been tested against enveloped viruses with moderate activity noted from the outset. To date, Brilacidin has not been tested specifically against Coronavirus (an enveloped positive stranded RNA virus). But the scientists who conducted preliminary research are optimistic about the multi-tiered advantages of Brilacidin to elicit a response when accompanied by drug optimization, formulation and delivery work.
The Company remains committed to its prioritization of ongoing clinical development of Brilacidin for Inflammatory Bowel Disease and Oral Mucositis in Head and Neck Cancer patients. As to Brilacidin’s antiviral properties, the strategy is to explore research collaborations and federal grant opportunities to further evaluate the drug’s potential to treat Coronaviruses without tapping into resources dedicated for clinical research in Brilacidin’s primary indications.
The Company plans to keep shareholders apprised, as appropriate, on any news related to evaluating Brilacidin’s antiviral properties in addition to its core Brilacidin programs, Ulcerative Colitis and Oral Mucositis.
Forward-Looking Statements: This shareholder alert contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning future drug development plans, other statements regarding future product developments, and markets, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause the Company’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are the Company’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock under securities purchase agreements; the fact that the Company’s licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments, or the fact that the Company’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in the Company’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. The Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
“Defensins are conceptually ideal for defense against different viral infections.”
Over the last few weeks, the Company has received inquiries asking about Brilacidin’s potential to treat the Coronavirus given the urgent worldwide need to find effective treatments for this deadly epidemic.
Coronavirus (now being referred to as “COVID-19”) continues to represent a significant life-threatening risk in China and throughout the world, with currently over 71,000 diagnosed cases across 29 countries, resulting in nearly 1,800 reported deaths. The containment of the COVID-19 outbreak is far from a certainty, as expressed by Prof Gabriel Leung, the Chair of Public Health Medicine at Hong Kong University, warning that the epidemic could spread to 60% of the world’s population if not controlled.
We have long discussed the broad therapeutic spectrum for our defensin mimetic franchise and are pleased to inform shareholders that we are now engaged in talks with leading institutions and researchers regarding the opportunity to explore developing Brilacidin, our lead defensin mimetic drug candidate. Interactions center on assessing Brilacidin as a potential novel antiviral therapy for treating Coronaviruses, including COVID-19 and potentially Middle East respiratory syndrome coronavirus (MERS-CoV) and severe acute respiratory syndrome coronavirus (SARS-CoV).
Some of the brightest minds in the field of virology see the therapeutic potential of defensins and defensin mimetics in helping to address unexpected epidemics, as detailed by Mee Sook Park, et al in a 2018 review article, linked to below:
Towards the Application of Human Defensins as Antivirals
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5933891/
“Due to the relative nonspecificity of the targets of defensins compared to those of the adaptive arm, antiviral applications of defensins are conceptually ideal for defense against different viral infections.”
Despite outbreaks of zoonotic coronaviruses (those that jumped from animals to humans) like COVID-19, MERS-Cov and SARS-CoV�cumulatively rresponsible for thousands of deaths� scientists have been challengeed to develop effective treatments given the latest current threat usually subsides before a drug or vaccine can be adequately tested for safety and efficacy.
To that point, there is a movement within academia and regulatory bodies towards testing the antiviral potential of late-phase and approved drugs. These drugs have more established pharmacodynamic and pharmacokinetic profiles, thereby offering the opportunity to greatly shorten the development timeframe should they prove beneficial in treating coronaviruses.
This is exactly where Brilacidin fits in into the emerging Coronavirus threat�a promising small molecule in late-phase development worthy off further evaluation as to its antiviral properties.
Brilacidin already has demonstrated broad and robust antibacterial, anti-inflammatory and immunomodulatory properties in multiple FDA clinical trials. Pre-clinical research also supports Brilacidin’s antiviral properties based on work by conducted by Dr. William DeGrado (UCSF) and Dr. Richard Scott (Fox Chase).
Brilacidin and other defensin mimetics similar in structure to Brilacidin have been tested against enveloped viruses with moderate activity noted from the outset. To date, Brilacidin has not been tested specifically against Coronavirus (an enveloped positive stranded RNA virus). But the scientists who conducted preliminary research are optimistic about the multi-tiered advantages of Brilacidin to elicit a response when accompanied by drug optimization, formulation and delivery work.
The Company remains committed to its prioritization of ongoing clinical development of Brilacidin for Inflammatory Bowel Disease and Oral Mucositis in Head and Neck Cancer patients. As to Brilacidin’s antiviral properties, the strategy is to explore research collaborations and federal grant opportunities to further evaluate the drug’s potential to treat Coronaviruses without tapping into resources dedicated for clinical research in Brilacidin’s primary indications.
The Company plans to keep shareholders apprised, as appropriate, on any news related to evaluating Brilacidin’s antiviral properties in addition to its core Brilacidin programs, Ulcerative Colitis and Oral Mucositis.
Forward-Looking Statements: This shareholder alert contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning future drug development plans, other statements regarding future product developments, and markets, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause the Company’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are the Company’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock under securities purchase agreements; the fact that the Company’s licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments, or the fact that the Company’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in the Company’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. The Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
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