thx Alan .. my email from Fido re: news rec'd @
Tue, Sep 10, 2019 9:00 am
Innovation Pharmaceuticals Plans for Clinical Trial of Oral Brilacidin for Ulcerative Colitis Program in 4th Quarter 2019
BEVERLY, MA – September 10, 2019 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to inform shareholders that the Company is planning for the first human trial utilizing an oral formulation of Brilacidin in the program for Ulcerative Colitis (UC), a common type of Inflammatory Bowel Disease (IBD), in December 2019. Brilacidin is the lead drug candidate in the Company’s portfolio of novel compounds called defensin-mimetics, which are modeled on the body’s host defense response and exhibit immunomodulatory, anti-inflammatory and anti-infective properties.
The Company is working closely with BDD Pharma to utilize their patented OralogiK™ tablet technology, enabling targeted delivery of Briladicin to the colon. The first planned clinical trial of oral Brilacidin in the UC program will be in healthy volunteers in the United Kingdom. We are now engaged in having our vendor prepare Brilacidin for shipment to BDD where it will be manufactured into tablets for the trial. Final feedback and approval from the governing regulatory agency will be required to commence the study. The trial is designed to assess safety, toleration, pharmacokinetics, and whether the drug is being dispersed directly in the colon.
With the continued development of Brilacidin in IBD, the Company is building upon its successfully completed Phase 2 Proof-of-Concept trial of locally-administered Brilacidin, as a retention enema, for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS). The compelling clinical data from the UP/UPS study demonstrated the robustness of Brilacidin to induce clinical remission in this indication, and resulted a licensing deal signed with Alfasigma S.p.A., a global pharmaceutical company based in Italy. Per the agreement, the Company received an upfront cash payment and will receive future milestone and royalty payments upon reaching program milestones and with commercialization.
“Initiating the upcoming trial of oral Brilacidin in the Ulcerative Colitis program is an extremely important next step. Companies in the IBD space that can deliver oral drug candidates with targeted delivery to the gut can attract significant investment and partnering interest,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “While executing the Alfasigma deal in UP/UPS was a key milestone for the Company, Brilacidin’s potential in UC and Crohn’s Disease is considerably larger. If oral Brilacidin performs in UC like we believe it can, we should find ourselves in a strong negotiating position toward securing additional licensing agreements in a market that runs into the tens of billions of dollars.”
“With pharmaceutical industry interest in defensin-based therapies intensifying, as we’ve been witnessing firsthand across recent partnering interactions, the planned upcoming UC program trial couldn’t be happening at a better time—an opportunity to further develop Brilacidin’s platform potential,” said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “Defensins function in a broad immunomodulatory capacity, exhibiting beneficial characteristics, both anti-inflammatory and anti-infective. Defensin-based therapies thus have the unique potential to treat a wide array of diseases. Brilacidin is the only defensin-based drug candidate in later-stage clinical testing—now anchored by successful results in Acute Bacterial Skin and Skin Structure Infection, Oral Mucositis and IBD—and is poised to be a potential game-changer in the field of promising therapeutics.”
The Company would also like to remind shareholders of the upcoming shareholder meeting on September 19.
Alerts
Sign-up for Innovation Pharmaceuticals email alerts is available at:
http://www.ipharminc.com/email-alerts/
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. 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.
Tue, Sep 10, 2019 9:00 am
Innovation Pharmaceuticals Plans for Clinical Trial of Oral Brilacidin for Ulcerative Colitis Program in 4th Quarter 2019
BEVERLY, MA – September 10, 2019 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to inform shareholders that the Company is planning for the first human trial utilizing an oral formulation of Brilacidin in the program for Ulcerative Colitis (UC), a common type of Inflammatory Bowel Disease (IBD), in December 2019. Brilacidin is the lead drug candidate in the Company’s portfolio of novel compounds called defensin-mimetics, which are modeled on the body’s host defense response and exhibit immunomodulatory, anti-inflammatory and anti-infective properties.
The Company is working closely with BDD Pharma to utilize their patented OralogiK™ tablet technology, enabling targeted delivery of Briladicin to the colon. The first planned clinical trial of oral Brilacidin in the UC program will be in healthy volunteers in the United Kingdom. We are now engaged in having our vendor prepare Brilacidin for shipment to BDD where it will be manufactured into tablets for the trial. Final feedback and approval from the governing regulatory agency will be required to commence the study. The trial is designed to assess safety, toleration, pharmacokinetics, and whether the drug is being dispersed directly in the colon.
With the continued development of Brilacidin in IBD, the Company is building upon its successfully completed Phase 2 Proof-of-Concept trial of locally-administered Brilacidin, as a retention enema, for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS). The compelling clinical data from the UP/UPS study demonstrated the robustness of Brilacidin to induce clinical remission in this indication, and resulted a licensing deal signed with Alfasigma S.p.A., a global pharmaceutical company based in Italy. Per the agreement, the Company received an upfront cash payment and will receive future milestone and royalty payments upon reaching program milestones and with commercialization.
“Initiating the upcoming trial of oral Brilacidin in the Ulcerative Colitis program is an extremely important next step. Companies in the IBD space that can deliver oral drug candidates with targeted delivery to the gut can attract significant investment and partnering interest,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “While executing the Alfasigma deal in UP/UPS was a key milestone for the Company, Brilacidin’s potential in UC and Crohn’s Disease is considerably larger. If oral Brilacidin performs in UC like we believe it can, we should find ourselves in a strong negotiating position toward securing additional licensing agreements in a market that runs into the tens of billions of dollars.”
“With pharmaceutical industry interest in defensin-based therapies intensifying, as we’ve been witnessing firsthand across recent partnering interactions, the planned upcoming UC program trial couldn’t be happening at a better time—an opportunity to further develop Brilacidin’s platform potential,” said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “Defensins function in a broad immunomodulatory capacity, exhibiting beneficial characteristics, both anti-inflammatory and anti-infective. Defensin-based therapies thus have the unique potential to treat a wide array of diseases. Brilacidin is the only defensin-based drug candidate in later-stage clinical testing—now anchored by successful results in Acute Bacterial Skin and Skin Structure Infection, Oral Mucositis and IBD—and is poised to be a potential game-changer in the field of promising therapeutics.”
The Company would also like to remind shareholders of the upcoming shareholder meeting on September 19.
Alerts
Sign-up for Innovation Pharmaceuticals email alerts is available at:
http://www.ipharminc.com/email-alerts/
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. 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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