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Innovation Pharmaceuticals Signs Drug Product Manufacturing Contract with CoreRx to Formulate and Package Brilacidin for Oral Mucositis in Sachet Form
BEVERLY, Mass., July 17, 2018 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to report the Company has signed a Drug Product manufacturing contract with CoreRx, a leading Contract Development Manufacturing Organization (CDMO), for formulating Brilacidin into granular form in unit dose sachets. Such drug product packaging in the form of sachets provides patients with a convenient, portable, quick-mixing “instant” Brilacidin oral rinse therapy.
Sachets are planned to be used in the continuing clinical evaluation of Brilacidin for the indication to decrease the incidence of Severe Oral Mucositis (SOM) (WHO Grade ≥ 3) in Head and Neck Cancer (HNC) patients receiving chemoradiation therapy.
The CoreRx agreement for Drug Product production aligns with one signed in April with another leading CDMO to, in parallel, bulk produce a commercial-grade supply of Brilacidin. Both of these manufacturing agreements serve to prepare for, and expedite, Brilacidin’s continued clinical development. Brilacidin is a defensin-mimetic drug candidate with unique immunomodulatory, anti-inflammatory, and antibacterial properties.
“CoreRx is pleased to have been selected by Innovation Pharmaceuticals for the development of Brilacidin sachets,” said Todd R. Daviau, President and CEO. “Having a sachet as a convenient oral therapy is long overdue in the treatment of oral mucositis, and we look forward to working with Innovation Pharmaceuticals to develop this new formulation and provide clinical trial supplies for this important indication.”
“Packaging Brilacidin in an easy-to-use sachet would likely substantially enhance its appeal and adoption among patients at risk for oral mucositis,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “IV-based oral mucositis therapies present distinct challenges to patients already overwhelmed with the burden of cancer care—requiring visitation to a hospital or a doctor’s office, and up to an hour (or more) to administer the drug. Brilacidin packaged in a sachet, in contrast, allows patients the convenience of taking their medication whether they are at home or elsewhere. Sachets are an optimal way of delivering much-needed treatments to this substantial patient population in need of an effective and easy to administer therapy.”
“This agreement with CoreRx is yet another important milestone positioning Brilacidin as one of the most promising drug candidates in late-stage development for the prevention and treatment of oral mucositis,” said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “CoreRx is now a valued contributor to advancing our Brilacidin development plan.”
About CoreRx Corporation
CoreRx is a Contract Development Manufacturing Organization (CDMO) with a focus on clinical phase drug product development, offering state of the art facilities to support supply chain needs throughout the entire clinical trial process. Integrated offerings provide comprehensive services for the development, manufacturing and testing of solid, liquid and semi-solid dosage forms, from pre-formulation work to final formulation development. More information is available at: www.corerxpharma.com.
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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. Positive results were also observed in a Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis. 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 Infections. 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. Prurisol, an oral psoriasis drug candidate acting through immune modulation and PRINS reduction, has now completed a Phase 2b trial and is awaiting statistical analysis. 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 projected timelines for the initiation and completion of clinical trials, our future drug development plans, other statements regarding future product developments, 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 to Aspire Capital; 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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