Innovation Pharmaceuticals Clinical Trial of Oral
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Posted On: 10/03/2019 9:47:25 AM
Innovation Pharmaceuticals Clinical Trial of Oral Brilacidin in Ulcerative Colitis Program Expected to Commence in December; Top-Line Data in Q1 2020
BEVERLY, Mass., Oct. 03, 2019 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to inform shareholders that management is finalizing documentation necessary to initiate the planned Phase 1 clinical trial of oral Brilacidin in its Ulcerative Colitis (UC) program. Document submissions are expected to be completed early in October, keeping the clinical trial on track for commencement in December.
The study evaluating Brilacidin in tablet form in healthy volunteers will be the first in a series of clinical trials, effectively launching the Company’s UC clinical program in the anchored Brilacidin franchise. Assessments will include the safety, toleration, pharmacokinetics of Brilacidin, and whether it is being dispersed directly in the colon. An expedient clinical trial, dosing of all cohorts is expected to be completed within three weeks of commencement. Top-line data are anticipated within 2-3 months, thereafter.
“Brilacidin has already met positive efficacy endpoints in various indications, delivered via different modes of administration, including intravenously, as an oral rinse and as a retention enema—thereby greatly enhancing the treatment potential of this novel defensin-mimetic compound. In collaboration with our oral formulation partner, BDD Pharma, we will be testing Brilacidin in a tablet version for the first time, which is a significant milestone for us as it is the preferred method of drug delivery for the UC indication,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “We’re targeting a lucrative market in Ulcerative Colitis where a new oral medication would command tremendous value. We feel confident in the tablet formulation of Brilacidin treating the broader disease of UC by selective delivery to the colon. This further complements our recent partnering of Brilacidin in Ulcerative Proctitis/Proctosigmoiditis with Italy’s Alfasigma. We look forward to providing more details on the planned Phase 1 trial of oral Brilacidin in the near future.”
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.
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email rec'd Thu, Oct 3, 2019 9:37 am
BEVERLY, Mass., Oct. 03, 2019 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to inform shareholders that management is finalizing documentation necessary to initiate the planned Phase 1 clinical trial of oral Brilacidin in its Ulcerative Colitis (UC) program. Document submissions are expected to be completed early in October, keeping the clinical trial on track for commencement in December.
The study evaluating Brilacidin in tablet form in healthy volunteers will be the first in a series of clinical trials, effectively launching the Company’s UC clinical program in the anchored Brilacidin franchise. Assessments will include the safety, toleration, pharmacokinetics of Brilacidin, and whether it is being dispersed directly in the colon. An expedient clinical trial, dosing of all cohorts is expected to be completed within three weeks of commencement. Top-line data are anticipated within 2-3 months, thereafter.
“Brilacidin has already met positive efficacy endpoints in various indications, delivered via different modes of administration, including intravenously, as an oral rinse and as a retention enema—thereby greatly enhancing the treatment potential of this novel defensin-mimetic compound. In collaboration with our oral formulation partner, BDD Pharma, we will be testing Brilacidin in a tablet version for the first time, which is a significant milestone for us as it is the preferred method of drug delivery for the UC indication,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “We’re targeting a lucrative market in Ulcerative Colitis where a new oral medication would command tremendous value. We feel confident in the tablet formulation of Brilacidin treating the broader disease of UC by selective delivery to the colon. This further complements our recent partnering of Brilacidin in Ulcerative Proctitis/Proctosigmoiditis with Italy’s Alfasigma. We look forward to providing more details on the planned Phase 1 trial of oral Brilacidin in the near future.”
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.
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email rec'd Thu, Oct 3, 2019 9:37 am
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