On October 26, 2017 Innovation Pharmaceuticals Inc. (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to report the completion of the Phase 2 trial (see link NCT02324335) of Brilacidin-OM for the prevention and treatment of Oral Mucositis (OM) in Head and Neck Cancer (HNC) patients receiving chemoradiation therapy (CRT). The final patient in the Phase 2 randomized, placebo-controlled clinical trial completed their post-therapy follow-up examination this week (Press release, Innovation Pharmaceuticals, OCT 26, 2017, View Source [SID1234521220]). The Company has begun the process of closing trial study sites and is now aggregating patient data for top-line analysis, to be reported this quarter.

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The primary objectives of the trial are the evaluation of the efficacy of Brilacidin-OM in reducing the incidence of severe OM (WHO Grade ≥3) compared to placebo during seven weeks of study treatment/CRT, and assessment of the safety and tolerability of this novel OM oral rinse therapy. A secondary objective includes evaluating the efficacy of Brilacidin in reducing the duration of severe OM.

The completion of the trial represents an important milestone, positioning the Company to address a significant unmet medical need. There are currently no FDA-approved drugs for preventing OM in patients with Head and Neck Cancer receiving chemoradiation. This painful condition affects upwards of 90 percent of patients in this population as well as a large number of patients receiving CRT for other cancers.

The Company believes that a successful Phase 2 trial would be a major breakthrough. Fast Track designation by the Food and Drug Administration (FDA) for Brilacidin-OM has already been awarded. In addition, the Company plans to apply for FDA Breakthrough Therapy Designation should top-line end of study results reflect similar efficacy (and safety) to that observed at interim, in which patients treated with Brilacidin-OM experienced a markedly reduced rate of severe OM compared to those on placebo.

“By 2030, the global annual incidence of Head and Neck Cancer is expected to exceed 1 million cases,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “It’s a horribly debilitating condition that causes tremendous suffering and leads to corresponding delays in clinical care, adding to costs and complications, for those who experience it. We look forward to compiling and releasing the topline Brilacidin-OM data, toward advancing it into a potential pivotal Phase 3 clinical trial—a final step toward Brilacidin-OM possibly emerging as the world’s first-ever approved preventative treatment for Oral Mucositis in this population.”

La Jolla Pharmaceutical has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On October 26, 2017 MabVax Therapeutics Holdings, Inc. (NASDAQ: MBVX), a clinical-stage oncology drug development company focused on the development of antibody-based products to address unmet medical needs in the treatment of cancer, reported that it will present three posters highlighting both new clinical findings and preclinical research accomplishments at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) being held October 26 – 30, 2017 in Philadelphia, Pennsylvania (Press release, MabVax, OCT 26, 2017, View Source [SID1234521221]).

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Paul Maffuid, Ph.D., Executive Vice President of Research and Development of MabVax, stated, “We look forward to sharing the significant progress we have made through these clinical and preclinical investigations. We will report new clinical data from our ongoing Phase 1 clinical trial and report on our most advanced preclinical program that demonstrates our growing expertise in the development of fully human antibodies targeting carbohydrate antigens expressed on many solid tumor cancers.”

The Company will present the following posters during the meeting:

Presenting Author: Paul Maffuid, Ph.D., Executive Vice President Research and Development, MabVax Therapeutics
Title: Using CA19-9 as a translational biomarker for sLea targeted agents MVT-5873 and MVT-1075 in cancer
Date & Time: Saturday, October 28, 2017 at 12:30 PM
Session: Poster Session A: Biomarkers
Location: Hall E, Pennsylvania Convention Center
Poster No.: 62
Abstract No.: A062

The poster summarizes preclinical development activities including a survey of CA19-9 positive cancers in patient tissue microarrays and patient sera samples treated with the anti-CA19-9 antibody MVT-5873 with potential utility as a translational biomarker.

Presenting Author: Paul Maffuid, Ph.D., Executive Vice President Research and Development, MabVax Therapeutics
Title: Preliminary Phase 1 data comparing HuMab-5B1 (MVT-5873), a monoclonal antibody targeting sLea, as a single agent and in combination with first line nab-paclitaxel and gemcitabine in patients with CA19-9 positive pancreatic cancer
Date & Time: Sunday, October 29, 2017 at 12:30 PM
Session: Late Breaking Poster Session B: Therapeutic Agents: Biological
Location: Hall E, Pennsylvania Convention Center
Poster No.: LB-25
Abstract No.: LB-B25

The poster summarizes interim data from the ongoing Phase 1 trial of MVT-5873 used as a single agent and in combination with a first line therapy in newly diagnosed patients with CA19-9 positive pancreatic cancer.

Presenting Author: G. Jonah Rainey, Ph.D., Executive Director Antibody Research, MabVax Therapeutics
Title: A therapeutic antibody candidate against the broadly expressed Tn and sTn carbohydrate cancer antigens
Date & Time: Sunday, October 29, 2017 at 12:30 PM
Session: Poster Session B: Therapeutic Agents: Biological
Location: Hall E, Pennsylvania Convention Center
Poster No.: 104
Abstract No.: B104

The poster summarizes the discovery, optimization, and target validation for the Company’s fully human antibodies targeting the Thomsen-nouveau (Tn) and the sialyl Tn (sTn) carbohydrate antigens for patients with ovarian and breast cancers.

Den 26 oktober 2017 rapporterade Xspray Pharma att de har fått godkännande för två sökta patent i USA (Press release, Xspray, OCT 26, 2017, View Source [SID1234523286]). Patentet omfattar komposition avseende produktkandidaterna HyNap-Sora och HyNap-Nilo. Det är Xsprays andra och tredje produktpatent som godkänns på huvudmarknaden i USA på kort tid. Bolaget har tidigare offentliggjort ett patentgodkännande i Japan och USA avseende HyNap-Dasa och har pågående ansökningsärenden för flera motsvarande patent i bland annat Japan och Europa.
"Nu har vi patent beviljade i USA som täcker de tre produkter vi avser att introducera på den amerikanska marknaden efter respektive original-substanspatent har löpt ut (under perioden 2020-2023). Vi har arbetar systematiskt och strategiskt med våra innovationer både för att förverkliga dem till produkter men också genom att säkra värdet med ett fullgott patentskydd. Jag ser det här som en bekräftelse på det arbetet," säger Per Andersson, vd för Xspray Pharma.

Xspray Pharma har erhållit godkännande ("notice of allowance") för två patent i USA avseende produktkandidaterna HyNap-Sora och HyNap-Nilo som är tänkta för behandling av vissa cancerformer. Det är Xsprays andra och tredje produktpatent som godkänns på den viktigaste marknaden, USA. Beskedet kommer i enlighet med bolagets plan att söka och erhålla patent för komposition och metod för samtliga tre produktkandidater under utveckling på de tre viktigaste marknaderna, USA, Europa och Japan.

"Med dessa patent, och de positiva resultaten från vår kliniska studie som vi nyligen offentliggjorde, har vi tagit viktiga steg mot målet att utveckla våra tre första produkter för lansering på den amerikanska marknaden," kommenterar Xsprays vd Per Andersson.

Xspray Pharmas aktier introducerades den 28 september på Nasdaq First North, efter en lyckosamt genomförd nyemission som tillförde bolaget 132 miljoner kronor före emissionskostnader. Planen är nu att använda kapitalet för att utveckla tre produktkandidater och blivande cancerläkemedel baserade på bolagets egenutvecklade teknologi, samt att introducera de första produkterna på den amerikanska marknaden under perioden 2020-2023.

On October 26, 2017 La Jolla Pharmaceutical Company (NASDAQ: LJPC) (the Company or La Jolla), a leader in the development of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, reported financial results for the three and nine months ended September 30, 2017 and highlighted recent corporate progress (Press release, La Jolla Pharmaceutical, OCT 26, 2017, View Source [SID1234521288]).

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Recent Corporate Progress

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In August 2017, La Jolla announced that the U.S. Food and Drug Administration (FDA) accepted for review the Company’s New Drug Application (NDA) for the investigational drug LJPC‑501, La Jolla’s propriety formulation of synthetic human angiotensin II, for the treatment of hypotension in adult patients with distributive or vasodilatory shock (dangerously low blood pressure with adequate cardiac function) who remain hypotensive despite fluid and vasopressor therapy (catecholamines and/or vasopressin). The review classification for the application is Priority, and the user fee goal date under the Prescription Drug User Fee Act (PDUFA) is February 28, 2018. In its letter to the Company, the FDA stated that it does not currently plan to hold an advisory committee meeting to discuss this application. The NDA for LJPC-501 is based on data from the ATHOS-3 (Angiotensin II for the Treatment of High Output Shock) multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical study of LJPC-501 in patients with distributive or vasodilatory shock who remain hypotensive despite fluid and vasopressor therapy, which were published by The New England Journal of Medicine in May 2017.

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In September 2017, an analysis from ATHOS-3 entitled, "Baseline angiotensin levels and ACE effects in patients with vasodilatory shock treated with angiotensin II," was presented during the 30th European Society of Intensive Care Medicine Annual Congress. The pre-specified analysis showed that a relatively low angiotensin II state (as measured by the ratio of angiotensin I to angiotensin II) predicted increased mortality in patients with vasodilatory shock, suggesting that a low angiotensin II state is a negative prognostic indicator of outcomes. Furthermore, the analysis showed a statistically significant treatment effect of LJPC-501 compared to placebo on mortality in these patients with a relatively low angiotensin II state (relative risk reduction of 36%; HR=0.64; 95% CI: 0.41-1.00; p=0.047).

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In September 2017, La Jolla announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued favorable Scientific Advice regarding the EU regulatory pathway for LJPC‑501 for the treatment of hypotension in adult patients with distributive or vasodilatory shock who remain hypotensive despite fluid and vasopressor therapy. Based on this Advice, La Jolla intends to submit a Marketing Authorization Application (MAA) for LJPC-501 in the third quarter of 2018.

"The first nine months of 2017 have been exciting for La Jolla, highlighted by the positive results from ATHOS-3, the publication of these results in The New England Journal of Medicine and the FDA acceptance of our NDA for LJPC-501," said George Tidmarsh, M.D., Ph.D., President and Chief Executive Officer of La Jolla. "We look forward to building on this momentum with the preparation for the potential commercial launch of LJPC-501, if approved by the FDA, and the initiation of our pivotal study of LJPC-401 in beta thalassemia patients suffering from iron overload."

Results of Operations

As of September 30, 2017, the Company had $120.8 million in cash and cash equivalents, compared to $65.7 million of cash and cash equivalents at December 31, 2016. Cash used in operating activities for the nine months ended September 30, 2017 was $60.4 million, compared to $40.1 million for the same period in 2016. Net loss for the three and nine months ended September 30, 2017 was $26.3 million and $76.3 million, or $1.19 per share and $3.65 per share, respectively, compared to a net loss of $21.3 million and $53.3 million, or $1.23 per share and $3.10 per share, respectively, for the same periods in 2016.