U.S. Regional Biocontainment Lab to Begin Testing of Brilacidin Against Coronavirus (COVID-19) Next Week
WAKEFIELD, MA – March 10, 2020 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to inform shareholders that management has been advised testing of Brilacidin, the Company’s flagship defensin mimetic drug candidate, as a novel experimental treatment against the latest coronavirus is scheduled to commence at one of the 12 U.S. Regional Biocontainment Labs (RBLs) during the week of March 16, 2020.
Scientists at the RBL will be evaluating Brilacidin against SARS-CoV-2, the specific coronavirus responsible for COVID-19 , the name given to the respiratory disease that has spread to 111 countries after being discovered in Wuhan City, Hubei Province, China in December 2019. More than 114,000 cases of COVID-19 have since been diagnosed, with over 4,000 deaths attributed to the virus.
There are currently no countermeasures approved by the U.S. Food and Drug Administration for treating COVID-19. On Friday, March 6, President Donald Trump signed an emergency bill allocating $8.3 billion in funds to combat COVID-19.
Brilacidin is a compelling investigational drug for COVID-19 due to its unique qualities to mimic the human innate immune system and Mechanism of Action that includes disruption of the membrane of pathogens, leading to cell death. Throughout laboratory and clinical studies, Brilacidin has demonstrated potent activity against Gram-positive bacteria, including Methicillin-resistant Staphylococcus aureus (MRSA), and coverage against Gram-negative bacteria. Research supports the ability of Brilacidin to swiftly penetrate a peptidoglycan layer in these difficult bacteria, which is key to rapid pathogen destruction and decreases the likelihood of drug resistance emerging.
The ability to penetrate cell walls engenders confidence in this opportunity to meet an urgent medical need in treating coronaviruses like COVID-19. COVID-19 is an “enveloped” virus, meaning it has a glycoprotein envelope surrounding its nucleocapsid. More succinctly, it has a lipid envelope derived from the host cell membranes studded with crown-like projections from which it is named.
The Company hopes to disclose the RBL’s research agenda for Brilacidin in the coming days. The upcoming research is being funded by third parties independent of Innovation Pharmaceuticals. The Company’s responsibility was only providing the Brilacidin and any requested data. The RBL now has the Brilacidin on site, as disclosed on Monday, March 9, 2020.
Penetrating the COVID-19 envelope could prove beneficial in designing a new drug or vaccine against the virus, although this would have to be confirmed through extensive laboratory and clinical research. No assurances are made or implied that testing will be successfully completed by the RBL or any other party.
As previously released, linked below (a downloadable pdf) is an overview document summarizing the scientific rationale for developing Brilacidin as a potential novel COVID-19 treatment, both as an intravenous medicine and as a vaccine.
“Background and Scientific Rationale for Brilacidin as a Potential Novel Coronavirus (COVID-19) Treatment” (March 1, 2020)
www.ipharminc.com/s/IPIX-Brilacidin-Defensin-Mimetics-COVID-19-Overview-March-1-2020-update.pdf
Alerts
Sign-up for Innovation Pharmaceuticals email alerts is available at:
http://www.ipharminc.com/email-alerts/
Brilacidin and COVID-19
The coronavirus (COVID-19) outbreak poses a significant life-threatening and economic risk throughout the world. There are no effective approved therapies to treat COVID-19. Brilacidin is one of the few drugs targeting COVID-19 that has been tested in human trials for other clinical indications, providing an established safety and efficacy profile, thereby potentially enabling it to rapidly help address the emerging worldwide coronavirus crisis, developed both as an intravenous medicine and as a vaccine. There is no assurance made or implied that testing Brilacidin for antiviral activity against any coronavirus will be successful.
About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious disease, and dermatologic diseases. Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics. A Phase 2 trial of Brilacidin as an oral rinse for the prevention of Severe Oral Mucositis (SOM) in patients with Head and Neck Cancer, met its primary and secondary endpoints, including reducing the incidence of SOM. The Company plans to advance Brilacidin oral rinse into Phase 3 development, subject to available financial resources. Positive results were also observed in a Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS). Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. in July 2019. A Phase 2b trial of Brilacidin showed a single intravenous dose of the drug delivered comparable outcomes to a seven-day dosing regimen of the FDA-approved blockbuster daptomycin in treating Acute Bacterial Skin and Skin Structure Infection. Kevetrin is a novel anti-cancer drug shown to modulate p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations and has successfully completed a Phase 2 trial in Ovarian Cancer. More information is available on the Company website at www.IPharmInc.com.
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning the future execution of a definitive agreement with a global pharmaceutical company and the anticipated terms thereof, our 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.
INVESTOR AND MEDIA CONTACT
Innovation Pharmaceuticals Inc.
Leo Ehrlich
info@ipharminc.com
WAKEFIELD, MA – March 10, 2020 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to inform shareholders that management has been advised testing of Brilacidin, the Company’s flagship defensin mimetic drug candidate, as a novel experimental treatment against the latest coronavirus is scheduled to commence at one of the 12 U.S. Regional Biocontainment Labs (RBLs) during the week of March 16, 2020.
Scientists at the RBL will be evaluating Brilacidin against SARS-CoV-2, the specific coronavirus responsible for COVID-19 , the name given to the respiratory disease that has spread to 111 countries after being discovered in Wuhan City, Hubei Province, China in December 2019. More than 114,000 cases of COVID-19 have since been diagnosed, with over 4,000 deaths attributed to the virus.
There are currently no countermeasures approved by the U.S. Food and Drug Administration for treating COVID-19. On Friday, March 6, President Donald Trump signed an emergency bill allocating $8.3 billion in funds to combat COVID-19.
Brilacidin is a compelling investigational drug for COVID-19 due to its unique qualities to mimic the human innate immune system and Mechanism of Action that includes disruption of the membrane of pathogens, leading to cell death. Throughout laboratory and clinical studies, Brilacidin has demonstrated potent activity against Gram-positive bacteria, including Methicillin-resistant Staphylococcus aureus (MRSA), and coverage against Gram-negative bacteria. Research supports the ability of Brilacidin to swiftly penetrate a peptidoglycan layer in these difficult bacteria, which is key to rapid pathogen destruction and decreases the likelihood of drug resistance emerging.
The ability to penetrate cell walls engenders confidence in this opportunity to meet an urgent medical need in treating coronaviruses like COVID-19. COVID-19 is an “enveloped” virus, meaning it has a glycoprotein envelope surrounding its nucleocapsid. More succinctly, it has a lipid envelope derived from the host cell membranes studded with crown-like projections from which it is named.
The Company hopes to disclose the RBL’s research agenda for Brilacidin in the coming days. The upcoming research is being funded by third parties independent of Innovation Pharmaceuticals. The Company’s responsibility was only providing the Brilacidin and any requested data. The RBL now has the Brilacidin on site, as disclosed on Monday, March 9, 2020.
Penetrating the COVID-19 envelope could prove beneficial in designing a new drug or vaccine against the virus, although this would have to be confirmed through extensive laboratory and clinical research. No assurances are made or implied that testing will be successfully completed by the RBL or any other party.
As previously released, linked below (a downloadable pdf) is an overview document summarizing the scientific rationale for developing Brilacidin as a potential novel COVID-19 treatment, both as an intravenous medicine and as a vaccine.
“Background and Scientific Rationale for Brilacidin as a Potential Novel Coronavirus (COVID-19) Treatment” (March 1, 2020)
www.ipharminc.com/s/IPIX-Brilacidin-Defensin-Mimetics-COVID-19-Overview-March-1-2020-update.pdf
Alerts
Sign-up for Innovation Pharmaceuticals email alerts is available at:
http://www.ipharminc.com/email-alerts/
Brilacidin and COVID-19
The coronavirus (COVID-19) outbreak poses a significant life-threatening and economic risk throughout the world. There are no effective approved therapies to treat COVID-19. Brilacidin is one of the few drugs targeting COVID-19 that has been tested in human trials for other clinical indications, providing an established safety and efficacy profile, thereby potentially enabling it to rapidly help address the emerging worldwide coronavirus crisis, developed both as an intravenous medicine and as a vaccine. There is no assurance made or implied that testing Brilacidin for antiviral activity against any coronavirus will be successful.
About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious disease, and dermatologic diseases. Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics. A Phase 2 trial of Brilacidin as an oral rinse for the prevention of Severe Oral Mucositis (SOM) in patients with Head and Neck Cancer, met its primary and secondary endpoints, including reducing the incidence of SOM. The Company plans to advance Brilacidin oral rinse into Phase 3 development, subject to available financial resources. Positive results were also observed in a Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS). Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. in July 2019. A Phase 2b trial of Brilacidin showed a single intravenous dose of the drug delivered comparable outcomes to a seven-day dosing regimen of the FDA-approved blockbuster daptomycin in treating Acute Bacterial Skin and Skin Structure Infection. Kevetrin is a novel anti-cancer drug shown to modulate p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations and has successfully completed a Phase 2 trial in Ovarian Cancer. More information is available on the Company website at www.IPharmInc.com.
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning the future execution of a definitive agreement with a global pharmaceutical company and the anticipated terms thereof, our 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.
INVESTOR AND MEDIA CONTACT
Innovation Pharmaceuticals Inc.
Leo Ehrlich
info@ipharminc.com
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