On December 12, 2017 Innovation Pharmaceuticals, (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, reported that the European Patent Office has granted a European patent for Brilacidin, the Company’s first-in-class defensin-mimetic, in the prevention and control of Oral Mucositis (OM) (Press release, Innovation Pharmaceuticals, DEC 12, 2017, View Source [SID1234522572]). Brilacidin-OM is being developed under an FDA Fast Track designation for this indication.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The European patent supplements other Brilacidin-OM patents that have been granted in the United States, Asia (Japan, Taiwan, China), Oceania (Australia) and South Africa. All currently issued patents have an expiration date of 2032. Additional Brilacidin-OM patent applications are pending in other key markets including Russia and South Korea.

The European patent is part and parcel to the Company’s strategy to develop and commercialize Brilacidin-OM internationally through licensing agreements. An estimated 700,000 (source: GLOBOCAN) Head and Neck Cancer (HNC) patients worldwide will develop OM this year, with the figures expected to climb to over one million annually by 2023. In spite of OM incidence rates ranging as high as 100 percent in HNC, there currently are no FDA-approved drugs for the prevention and treatment of OM in these types of cancer patients receiving chemoradiation.

"We are looking at a global product opportunity with OM that is extremely attractive and intellectual property protection is critical. With no approved drugs for our initial target indication in preventing OM in HNC, the first company to commercialize a safe and effective drug would undoubtedly command a significant portion of the market, which is estimated to be at least $1 billion worldwide," said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals.

"The topline data released yesterday from our Phase 2 trial showed a meaningful reduction in the incidence of severe OM even compared to a rate somewhat lower than historic norms in the placebo arm, demonstrating Brilacidin-OM’s clear effect in preventing this extremely painful, and at times even deadly, consequence of chemoradiation in a majority of HNC patients treated with the drug. I can’t imagine a physician not wanting to prescribe, and a patient not wanting to use, a simple oral rinse like Brilacidin-OM if it would mean cutting the chance of developing severe OM by as much as 38.7 percent, as observed in patients who adhered to the requirements of the trial protocol," Mr. Ehrlich continued.

"Given the positive topline data, the Company is compelled to aggressively seek a development path that will most efficiently bring Brilacidin-OM to patients in need," said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. "We intend to work diligently with the FDA and other health authorities, on a worldwide basis, and ideally in collaboration with interested potential partners, to achieve this goal. We have a potential "game changer" asset with Brilacidin-OM, able to make a big impact on a cancer patient’s well-being, and we are in the privileged position of planning wholeheartedly for the next stage of development as we strive to be the first to fill a wide void in oncology as quickly as possible."

On December 12, 2017 GlycoMimetics, Inc. (NASDAQ: GLYC) reported updated data from the Phase 1/2 trial evaluating the safety, tolerability and efficacy of GMI-1271 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and in older adults with newly diagnosed AML, including the following conclusions (Press release, GlycoMimetics, DEC 12, 2017, View Source [SID1234522581]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

For patients with R/R AML treated at the Phase 2 dose (n = 54) and for whom median follow up was 6.6 months:

Clinical remission (CR+CRi) was 43%.
Median overall survival was 9.4 months (95% CI: 5.7 – 15.1 months; calculated by Kaplan Meier method). This compares favorably to a median overall survival of up to 5.4 months reported for historical, matched controls treated with mitoxantrone, etoposide and cytarabine (MEC) alone. 1,2
Median duration of remission was 11.1 months (95% CI: 5.8-NA; calculated by Kaplan Meier method).
For older patients with newly diagnosed disease (n=25) and for whom median follow up was 10.5 months:

Clinical remission rate was 68%.
Median overall survival was 15.8 months (95% CI: 10.3 – NA; calculated by Kaplan Meier method). This compares favorably to a historical median overall survival of approximately 12 months in matched controls treated with 7+3 chemotherapy alone. 3,4
Median duration of remission was 14.8 months (95% CI: 8.3 – NA; calculated by Kaplan Meier method).
Median event free survival was 11.3 months.
The data were presented yesterday during an oral scientific session at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Expo in Atlanta.

Across both populations, GMI-1271 was well tolerated with no obvious incremental toxicity observed and lower than expected rates of severe, debilitating, grade 3-4 mucositis reported (e.g., 3% incidence reported vs. historical 20-25% incidence with MEC alone).

"These new data from our Phase 1/2 clinical trial demonstrate that encouraging clinical outcomes are possible for both duration of remission and survival endpoints when GMI-1271 is added to chemotherapy in two distinct AML patient populations," noted Helen Thackray, M.D., FAAP, GlycoMimetics Senior Vice-President, Clinical Development and Chief Medical Officer. "Beyond the high response rates previously reported with GMI-1271, we can now point to additional long-term endpoints that further support our plan to move the drug candidate into a Phase 3 clinical trial scheduled to begin in mid-2018. Importantly, with respect to safety, the low mucositis rate in relapsed and refractory patients receiving MEC induction chemotherapy — where you would expect around 25% severe mucositis — is quite striking. This was predicted and explained by preclinical models in which GMI-1271 blocked inflammatory macrophages trafficking to the gut and thus prevented mucosal injury."

"These results continue to show that AML patients treated with GMI-1271 consistently perform better than expected," said Daniel J. DeAngelo, M.D., Ph.D., the trial’s lead investigator and Director of Clinical and Translational Research, Adult Leukemia Program, at the Dana-Farber Cancer Institute and Brigham and Women’s Hospital, who presented the data at the ASH (Free ASH Whitepaper) Annual Meeting. "Our Phase 2 population consists of very high-risk patients based on age, disease status, and cytogenetic risk factors. The updated data continue to support the concept that disrupting the relationship between leukemic cells and the protective bone marrow microenvironment, when combined with chemotherapy, could improve the outlook and prognosis for these patients."

The second oral presentation at the ASH (Free ASH Whitepaper) meeting highlighted a preclinical study in murine models of AML in which E-selectin was shown to be upregulated, and AML cells binding to E-selectin increased chemo-resistance by activating specific tumor cell survival signaling pathways. This effect within the bone marrow microenvironment is unique to E-selectin as compared to other vascular adhesion molecules and can be blocked by GMI-1271. This translational research provides important evidence that elucidates how treatment with GMI-1271 appears to be improving sensitivity to chemotherapy.

"Given response rates we’ve observed to date that suggest clinical benefit in combination with chemotherapy in two AML populations, this preclinical work provides important further support for the mechanism of action of GMI-1271," noted Dr. Thackray. "Together, the clinical and preclinical data we have shared at the ASH (Free ASH Whitepaper) Annual Meeting demonstrate that GMI-1271 could represent a novel and truly differentiated approach to treatment of AML," Dr. Thackray concluded.

Meeting abstracts are available on ASH (Free ASH Whitepaper)’s website.

GlycoMimetics to Hold Post-ASH Meeting Briefing in Boston on December 19

GlycoMimetics will hold a briefing for investors/analysts, which will also be available via webcast, to review the GMI-1271 program with a focus on the AML clinical data presented at the ASH (Free ASH Whitepaper) Annual Meeting, at the Langham Hotel in Boston, December 19, at 7:30 a.m. EST. Dr. DeAngelo will present the clinical data from the ASH (Free ASH Whitepaper) oral presentation and respond to questions from on-site participants.

On December 12, 2017 Repros Therapeutics Inc. (NASDAQ: RPRX) ("Repros" or the "Company") reported that it has entered into a definitive agreement under which Allergan plc ("Allergan"), through a subsidiary, will acquire Repros for a cash payment of $0.67 per share (Press release, Repros Therapeutics, DEC 12, 2017, View Source [SID1234522585]). The Company’s Board of Directors has unanimously approved the transaction.

Under the terms of the merger agreement, a subsidiary of Allergan will commence a cash tender offer to purchase all of the outstanding shares of Repros common stock for $0.67 per share. The closing of the tender offer is subject to customary closing conditions, including the tender of a majority of the outstanding shares of Repros common stock. The merger agreement contemplates that Allergan, through its subsidiary, will acquire any shares of Repros that are not tendered into the offer through a second-step merger, which will be completed as soon as practicable following the closing of the tender offer. Pending approvals, Repros anticipates the transaction will close during the first quarter of 2018.

Stifel, Nicolaus & Company, Incorporated is serving as exclusive financial advisor to Repros, and Morgan, Lewis & Bockius LLP is serving as Repros’ legal counsel. Covington & Burling LLP is serving as Allergan’s legal counsel.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On December 12, 2017 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that data from the EMBRACA trial showed Myriad’s BRACAnalysis CDx test successfully identified patients with metastatic breast cancer (MBC) who responded to Pfizer’s investigational PARP inhibitor, talazoparib (Press release, Myriad Genetics, DEC 12, 2017, View Source [SID1234522582]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The EMBRACA trial (NCT01945775) data were presented last week at the 2017 San Antonio Breast Cancer Symposium (SABCS). The study included approximately 400 patients, all of whom tested positive for germline BRCA mutations as determined by Myriad’s FDA-approved BRACAnalysis CDx test. As presented at SABCS, the results demonstrated that patients with gBRCA+ locally advanced and/or MBC demonstrated superior progression-free survival (PFS) in patients treated with talazoparib, compared to patients who received physician’s choice standard-of-care chemotherapy. Additionally, the PFS benefit was consistent across metastatic BRCA-positive patients, including those with hormone receptor-positive and triple negative disease.

"BRACAnalysis CDx is the only germline companion diagnostic test approved by the FDA to identify patients with BRCA1/2 mutations, and we are excited to support Pfizer’s clinical development program and help identify patients who are most likely to benefit from talazoparib," said Mark C. Capone, president and CEO, Myriad Genetics. "As the pioneers in companion diagnostics for PARP inhibitors, we are excited that more patients may benefit from these novel drugs in the future."

It is estimated there are approximately 60,000 patients with metastatic breast cancer, two thirds of whom are not currently eligible for BRCA testing based upon family and personal history alone or current testing criteria.

Myriad first announced its collaboration to develop a novel companion diagnostic test for talazoparib on Oct. 1, 2013. Under that agreement (originally with BioMarin; now Pfizer), Myriad plans to submit a supplementary premarket approval (sPMA) application to the U.S. Food and Drug Administration (FDA) under its existing PMA for BRACAnalysis CDx to include talazoparib.

About BRACAnalysis CDx
BRACAnalysis CDx is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA. Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR. Results of the test are used as an aid in identifying ovarian cancer patients with deleterious or suspected deleterious germline BRCA variants, who are or may become eligible for treatment with Lynparza (olaparib). Detection of deleterious or suspected deleterious germline BRCA variants by the BRACAnalysis CDx test in ovarian cancer patients is also associated with enhanced progression-free survival (PFS) from Zejula (niraparib)maintenance therapy. This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single laboratory site located at 320 Wakara Way, Salt Lake City, UT 84108. Learn more at: View Source

On December 12, 2017 Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) reported financial results for its fiscal 2017 fourth quarter and year ended September 30, 2017 (Press release, Arrowhead Research Corporation, DEC 12, 2017, View Source [SID1234522592]). The company is hosting a conference call at 4:30 p.m. EST to discuss results.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Conference Call and Webcast Details

Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 6977547.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 6977547.

Selected Fiscal 2017 and Recent Events

Hosted an Analyst R&D Day in September 2017 to highlight the following:
The Targeted RNAi Molecule platform, or TRiM, which utilizes ligand-mediated delivery and is designed to enable tissue-specific targeting, while being structurally simple
The TRiM platform offers several potential competitive advantages including:
Simplified manufacturing at reduced cost
Multiple routes of administration (subcutaneous, intravenous, and inhaled)
Faster time to clinical candidates
Wide safety margins
Promise of taking RNAi to tissues beyond the liver
ARO-AAT, Arrowhead’s second generation subcutaneously administered clinical candidate for the treatment of alpha-1 antitrypsin deficiency liver disease with a planned Clinical Trial Application (CTA) filing in Q1 2018
ARO-HBV, Arrowhead’s third generation subcutaneously administered clinical candidate for the treatment of chronic hepatitis B virus infection with a planned CTA filing in Q2 2018
Arrowhead’s expanded cardiometabolic pipeline, which now includes ARO-APOC3, targeting apolipoprotein C-III, and ARO-ANG3, targeting angiopoietin-like protein 3 (ANGPTL3) with CTA filings planned around the end of 2018
The TRiM platform’s ability to target extra-hepatic tissues, including the lung and tumors, represented by the following programs:
ARO-Lung1, the first candidate against an undisclosed gene target in the lung, which achieved almost 90% target knockdown following inhaled administration in rodents
ARO-HIF2, Arrowhead’s candidate targeting renal cell carcinoma, which achieved 85% target gene knockdown in a rodent tumor model
CTA filings are planned in Q4 2018 and in 2019 for ARO-Lung1 and ARO-HIF2, respectively
Presented new clinical data at HEP DART 2017 demonstrating up to 5.0 log10 reduction in HBV s-antigen and a Sustained Host Response in 50% of hepatitis B patients following RNAi therapy, ARC-520, in the 2001 open label extension study
Made continued progress on our two-product cardiovascular collaboration with Amgen, in which one that was previously called ARO-LPA against the target lipoprotein(a) has been formally nominated as a clinical candidate and which is now referred to as AMG-890 by Amgen