On March 28, 2019 Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage pharmaceutical company, reported that the European Medicines Agency (EMA) has granted a meeting with the Company’s European subsidiary, IPIX Pharma Ltd., to discuss a briefing package submitted for Scientific Advice regarding the clinical development program of Brilacidin oral rinse to decrease the incidence of Severe Oral Mucositis (SOM) in Head and Neck Cancer (HNC) patients receiving chemoradiation (Press release, Innovation Pharmaceuticals, MAR 28, 2019, View Source [SID1234534715]).

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The purpose of such meetings is for the EMA to provide guidance on the appropriate tests and studies in the development program for a medicine. Receiving formal scientific advice helps ensure health authority alignment regarding appropriate testing to support an eventual marketing-authorization application in Europe.

The meeting with IPIX Pharma has been scheduled by EMA for mid-April 2019 and will serve to complement the regulatory feedback and advice obtained by the Company from the already completed End-of-Phase 2 Meeting held with the U.S. Food and Drug Administration (FDA). At this meeting, an acceptable Phase 3 development pathway was agreed upon by the FDA and the Company to advance Brilacidin for the prevention of SOM in HNC.

"We are extremely pleased to have been granted this scientific meeting with the EMA, particularly in such rapid fashion," commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. "New and effective treatments that not only help mitigate, but actually prevent the occurrence of oral mucositis, have been long sought-after. Currently there is no approved drug to decrease the incidence of Severe Oral Mucositis in Head and Neck Cancer. We look forward to advancing Brilacidin toward potential regulatory approval, both in Europe and the United States, as we refine key aspects of our planned Phase 3 program in oral mucositis."

About Brilacidin Phase 2 Results in Treating Severe Oral Mucositis

The Company’s Brilacidin oral rinse demonstrated a strong therapeutic benefit in patients receiving an aggressive chemotherapy regimen (cisplatin administered 80-100 mg/m2, every 21 days), which currently is the standard of care. In this patient population, the incidence of SOM was reduced to 25.0% in the modified Intent-to-Treat (mITT) population, versus 71.4% of patients on placebo. In the Per Protocol (PP) patient group, incidence of SOM dropped to 14.3% for patients receiving Brilacidin-OM, compared to 72.7% among those receiving placebo.

The completed Phase 2 study met its primary endpoint, showing a reduction of SOM incidence versus placebo, as well as beneficial treatment effects in reducing the duration of SOM and in delaying the onset of SOM.

Linked below is information, published in a blog on the Company’s website, elaborating on how Brilacidin is positioned compared to other investigational Oral Mucositis drugs currently in clinical development.

View Source
About Brilacidin and Severe Oral Mucositis

There currently are no FDA-approved drugs to decrease the incidence of Severe OM (SOM) (WHO Grade ≥ 3) in Head and Neck Cancer (HNC) patients receiving chemoradiation. The additional expenses incurred by patients suffering from SOM are estimated to be as high as $18,000 to $25,000 per case in the U.S. when hospitalization is required. These factors contribute to SOM qualifying as an area of significant unmet medical need. According to published statistics, the number of new annual HNC cases in the U.S. is estimated to be 65,000, and on a worldwide basis, ~750,000 cases. Between 60 and 70 percent of these HNC patients typically will develop SOM, with the overall incidence of HNC patients developing some grade of OM (WHO Grades 1 to 4) approaching 100 percent. Because it cannot be predicted which patients will develop SOM, a preventative treatment, such as Brilacidin oral rinse, would begin in all patients as soon as starting chemoradiation and continue until its completion (typically a seven-week course). Given Brilacidin is administered as a convenient oral rinse, with plans to package it in an easily transportable sachet form, the Company believes it would be attractive both to doctors and patients—likely translating to widespread and rapid market adoption should Brilacidin oral rinse gain regulatory approval.

On March 28, 2019 Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis (OM), reported it will present and meet with investors at Spring Investor Summit on April 1, 2019 at 1:00 PM ET as part of Track 1 at The Essex House in New York City (Press release, Oragenics, MAR 28, 2019, View Source [SID1234534714]).

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Interested investors may request a one-on-one meeting at Spring Investor Summit by registering for the meeting at www.microcapconf.com, or contacting conference administrators at [email protected].

On March 28, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reportd that it will host a conference call and webcast discussion regarding the positive topline results from its pivotal clinical trial of enfortumab vedotin in locally advanced or metastatic urothelial cancer, which were announced in a press release earlier today (Press release, Seattle Genetics, MAR 28, 2019, http://investor.seattlegenetics.com/news-releases/news-release-details/seattle-genetics-host-conference-call-positive-topline-results [SID1234534713]). Access to the event can be obtained as follows:

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LIVE access on Thursday, March 28, 2019

6:00 a.m. Pacific Time (PT) / 9:00 a.m. Eastern Time (ET)

Telephone 866-288-0540 (domestic) or +1 786-460-7199 (international); conference ID 3807860
Webcast available at www.seattlegenetics.com in the Investors section
REPLAY access

Telephone replay will be available until 5:00 p.m. PT on Monday, April 1, 2019 by calling 888-203-1112 (domestic) or +1 719-457-0820 (international); conference ID 3807860
Webcast replay will be available on the Seattle Genetics website at www.seattlegenetics.com in the Investors section

On March 28, 2019 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported financial results for the year ended December 31, 2018 (Press release, Can-Fite BioPharma, MAR 28, 2019, View Source [SID1234534712]).

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Clinical Development and Corporate Highlights During 2018 Include:

In a deal worth up to $74.5 million, Can-Fite signed a License, Collaboration and Distribution Agreement with CMS Medical Venture Investment Limited for the commercialization of Piclidenoson in the treatment of rheumatoid arthritis and psoriasis, and Namodenoson in the treatment of advanced liver cancer and NAFLD/NASH, in China.
In another multi-million dollar deal, Can-Fite signed a distribution deal with Gebro Holding GmBH in Spain, Switzerland, and Austria, to distribute Piclidenoson in the treatment of rheumatoid arthritis and psoriasis upon receipt of regulatory approval.
Can-Fite raised $5 million through a registered direct offering.
Can-Fite recently reported top line result from its Phase II trial of Namodenoson in the treatment of advanced liver cancer. While the study did not achieve its primary end point of median overall survival in the whole population of 78 patients, it did achieve superiority in median overall survival in the largest study subpopulation of 56 patients and in secondary end points for the whole population. These data support progression into a Phase III study.
Phase III clinical studies of Piclidenoson in the treatment of psoriasis and rheumatoid arthritis continue to enroll patients.
Top-line Data from Phase II NASH Study with Namodenoson expected in H2 2019
"2018 marked significant achievements for Can-Fite including our largest distribution deal to date valued at up to $74.5 million. We continued to build our intellectual property assets, presented new data at scientific conferences and saw our findings published in peer reviewed journals. We are particularly pleased to move much closer to commercialization with both Piclidenoson, now in two Phase III studies, and Namodenoson, now completing a Phase II study," stated Can-Fite CEO Pnina Fishman. "We just announced top line results from our Phase II Namodenoson study in advanced liver cancer which produced encouraging results to move into a Phase III, even though the primary end point was not met. We believe our drugs’ strong safety profile, combined with efficacy in a specific sub-population within each target disease indication will improve patient health and longevity."

Financial Results

Revenues for the year ended December 31, 2018 were $3.8 million, an increase of $3.0 million, or 384%, compared to $0.8 million for the year ended December 31, 2017. The increase in revenue was mainly due to the recognition of a $2 million advance payment received in August 2018 under the License, Collaboration and Distribution Agreement with CMS Medical and from the recognition of a portion of the $2.2 million advance payment received in January 2018 under the Distribution and Supply Agreement with Gebro.

Research and development expenses for the year ended December 31, 2018 were $6.0 million, an increase of $0.9 million, or 19%, compared to $5.1 million for the year ended December 31, 2017. Research and developments expenses for the year ended 2018 comprised primarily of expenses associated with the Phase II studies for Namodenoson as well as expenses for ongoing studies of Piclidenoson. The increase is primarily due to increased costs associated with the initiation of the Phase III clinical trial of Piclidenoson for the treatment of rheumatoid arthritis. We expect that the research and development expenses will increase through 2019 and beyond.

General and administrative expenses were $3.1 million for the year ended December 31, 2018 an increase of $0.3 million, or 10%, compared to $2.8 million for the year ended December 31, 2017. The increase is primarily due to an increase in professional services and investor relations expenses. We expect that general and administrative expenses will remain at the same level through 2019.

Financial expenses, net for the year ended December 31, 2018 aggregated $1.1 million compared to immaterial financial income, net for the same period in 2017. The increase in financial expense, net was mainly due to a loss from long-term investment revaluation and from recognition of interest expenses related to implementation of revenue recognition accounting standard IFRS 15, while in the same period in 2017, financial income was mainly due to fair value revaluation of warrants which were offset by financial expenses from exchange rate differences.

Net loss for the year ended December 31, 2018 was $6.6 million compared with a net loss of $6.4 million for the year ended December 31, 2017. The increase in net loss for the year ended December 31, 2018 was primarily attributable to increase in revenues in 2018 which were offset by an increase in research and development expenses and increase in finance expenses, net.

As of December 31, 2018, Can-Fite had cash and cash equivalents of $3.6 million as compared to $3.5 million at December 31, 2017. The increase in cash during the year ended December 31, 2018 is due to increase in net cash provided by financing activity which was offset by a decrease in net cash used in operating activity. In January 2019, Can-Fite raised $2.35 million in a registered direct offering.

On March 28, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported the publication of an article highlighting the synergistic effect of oncolytic immunotherapy in combination with a proteasome inhibitor in the treatment of multiple myeloma (Press release, Oncolytics Biotech, MAR 28, 2019, View Source [SID1234534709]). The article, entitled, "Oncolytic immunotherapy and bortezomib synergy improves survival of refractory multiple myeloma in a preclinical model," co-authored by Oncolytics’ President and Chief Executive Officer, Dr. Matt Coffey was published in the March 12 edition of Blood Advances.

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The article demonstrates that the combination of reovirus and bortezomib can overcome drug resistance, a major hurdle in the treatment of multiple myeloma. Further, the combination modifies the tumor microenvironment to overcome the immune suppressive environment caused by multiple myeloma cells in the bone marrow. This combination promotes a pro-inflammatory signal within the tumor microenvironment, upregulates the PD-L1/PD-1 axis and enhances immune cell infiltration. Collectively, this suggests the possibility of synergies and increased efficacy with the addition of checkpoint blockade to the combination.

"We’d like to thank our collaborators for this influential work which provides further evidence that the combination of pelareorep with a proteasome inhibitor can synergistically overcome drug resistance and drive enhanced tumor killing and superior overall survival in animal models," said Dr. Rita Laufle, Chief Medical Officer of Oncolytics. "Importantly, the combination engages the immune system in a manner that converts tumor indications that have not been responsive to checkpoint blockade to those that are responsive, by both reversing the immune suppressive aspects of the tumor microenvironment while increasing immune cell trafficking to the tumor and generating new anti-tumor memory T cells. These findings are consistent with our clinical observations that proteasome inhibition, in combination with reovirus, primes the tumor for checkpoint blockade and further validates our combination studies in this and other indications, including our most advanced indication, metastatic breast cancer."

Blood Advances is a semimonthly, peer-reviewed medical journal published by the American Society of Hematology (ASH) (Free ASH Whitepaper). A copy of the paper can be found on our website: View Source

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.