On January 8, 2019 Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage pharmaceutical company, is pleased to inform shareholders of recent articles published in "The Lancet," a leading independent, international journal for medical professionals, detailing data from two, separate clinical studies1,2 of radiotherapy plus ERBITUX (cetuximab) or cisplatin in treating oropharyngeal cancer, a type of Head and Neck Cancer (HNC) (Press release, Innovation Pharmaceuticals, JAN 8, 2019, View Source [SID1234532565]).
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The findings from the large studies are particularly great news for the Company and relevant for development of Brilacidin oral rinse under a U.S. Food and Drug Administration (FDA) Fast Track designation as a new drug candidate for the prevention and treatment of severe Oral Mucositis (OM) in HNC patients receiving chemoradiation.
Cetuximab, an Epidermal Growth Factor Receptor inhibitor, has been hypothesized as a less toxic option to cisplatin, a drug commonly used today in combination with radiotherapy in HNC treatment regimens. While effective, cisplatin is known to have certain toxicities, including frequently causing severe OM, a debilitating and painful side effect characterized by lesions in the mouth’s mucosa that can force suspension of cancer therapy, render a patient unable to eat or drink and increase risk of sepsis, among other complications. There are currently no FDA-approved drugs for the prevention and treatment of OM for patients with solid tumors.
In each study, replacing cisplatin/radiotherapy with cetuximab/radiotherapy delivered inferior results when evaluated for overall survival, progression-free survival, or tumor control and no difference in overall severe toxicity. Although each study should be considered landmark on its own, the harmonized results are most notable in showing that the combination of cisplatin and radiotherapy will remain a standard of care in treating HNC.
"These data indicate that a cisplatin/radiotherapy regimen is likely to continue to be a mainstay in treating HNC, in spite of the drug commonly causing severe OM. A glaring critical void in patient care — and, thus, comprising a tremendous market opportunity for the Company — is in developing a safe and effective treatment that can become part of the standard regimen to prevent severe OM," commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. "We are highly confident that Brilacidin oral rinse could fill that large therapeutic gap in cancer care and give patients preventative relief from a frequently occurring and horrible consequence of chemoradiation."
In the Company’s successfully completed Phase 2 trial, Brilacidin oral rinse significantly reduced the incidence of severe OM (WHO Grade ≥ 3) in HNC patients receiving cisplatin administered 80-100 mg/m2 every 21 days in combination with radiotherapy. In this patient population, incidence of severe OM was reduced to 25.0 percent in the modified Intent-to-Treat population, versus 71.4 percent of placebo patients. In the Per Protocol patient group, incidence of severe OM dropped to 14.3 percent for patients receiving Brilacidin, compared to 72.7 percent among those receiving placebo.
The Company recently completed an End-of-Phase 2 meeting with the FDA, paving the way for pivotal trials of Brilacidin oral rinse for HNC patients receiving chemoradiation. In Phase 3 trials, Brilacidin will be evaluated in patients receiving aggressive chemotherapy (cisplatin administered 80-100 mg/m2 every 21 days) and in those receiving less aggressive chemotherapy (cisplatin administered 30-40 mg/m2 weekly) as part of the chemoradiation regimen.
In its goal to build a world-class clinical asset across the Brilacidin franchise, with the indication of severe OM a Company priority, Innovation Pharmaceuticals is preparing to seek scientific advice from the European Medicines Agency to round out European Union program requirements for Phase 3 clinical trials.