On September 28, 2015 Heron Therapeutics, Inc. (NASDAQ:HRTX), a biotechnology company focused on improving the lives of patients by developing best-in-class medicines that address major unmet medical needs, reported that data from the recently completed Phase 3 MAGIC study of SUSTOL (granisetron) Injection, extended release, were presented by Ian Schnadig, M.D., Principal Investigator for the MAGIC trial, US Oncology Research, Compass Oncology, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2015 Breast Cancer Symposium in San Francisco, CA (Press release, Heron Therapeutics, SEP 28, 2015, View Source;p=RssLanding&cat=news&id=2090853 [SID:1234507589]). These data were presented in an oral presentation and poster titled "Phase III Study of APF530 versus Ondansetron with a Neurokinin 1 Antagonist + Corticosteroid in Preventing Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: MAGIC Trial." SUSTOL is Heron’s lead product candidate for the prevention of chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC). SUSTOL has not been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. Heron Therapeutics resubmitted its New Drug Application (NDA) for SUSTOL with the FDA in July 2015.

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Highlights include:

The MAGIC trial represents the first registrational Phase 3 efficacy trial in patients receiving HEC using a consensus guideline–recommended three-drug regimen in both arms.

For the primary endpoint, the proportion of patients with delayed-phase complete response (CR) was significantly greater with the SUSTOL (64.7%) versus ondansetron regimen (56.6%), an absolute treatment difference of 8.0% (95% CI 1.7-14.4; p = 0.014), equating to a relative 14.2% CR rate improvement.

Within the cisplatin stratum (≥50 mg/m2), delayed-phase CR was greater with the SUSTOL (65.3%) versus ondansetron regimen (54.7%), an absolute treatment difference of 10.6% (95% CI -1.4-22.7), equating to a relative 19.4% CR rate improvement.
A significantly greater proportion of patients did not require rescue medication in the delayed phase with the SUSTOL versus ondansetron regimen (p = 0.013).

Patient-reported satisfaction with nausea and vomiting control was significantly greater with the SUSTOL versus ondansetron regimen in the delayed phase (p = 0.040).

Rates of no nausea were numerically higher in the SUSTOL versus ondansetron regimen in the delayed and overall phases and a post hoc analysis indicated SUSTOL was associated with significantly less frequent nausea in the delayed (p = 0.032) and overall phases (p = 0.048).

SUSTOL was generally well tolerated with no new safety signals identified.
"The prevention of nausea and vomiting associated with highly emetogenic chemotherapy remains a significant unmet medical need for patients battling cancer," stated Dr. Ian Schnadig, M.D., Principal Investigator, US Oncology Research, Compass Oncology, "SUSTOL, as part of a three-drug anti-emetic regimen, is the first and only 5-HT3 antagonist to demonstrate superiority over current standard-of-care for preventing delayed CINV following HEC. I am encouraged by the results of the MAGIC trial and feel that SUSTOL represents a potentially best-in-class agent for the prevention of CINV."

"We believe that SUSTOL, due to its novel extended-release formulation, has the potential to be the new standard in the prevention of both acute and delayed nausea and vomiting in patients undergoing cancer chemotherapy," commented Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics. "The data presented at the ASCO (Free ASCO Whitepaper) Breast Cancer Symposium further demonstrate the potential utility of SUSTOL. With a PDUFA goal date of January 17, 2016 assigned from the U.S. Food and Drug Administration following the resubmission of our New Drug Application (NDA), we are looking ahead to the potential approval and commercial launch of this very important medication."

About SUSTOL for Chemotherapy-Induced Nausea and Vomiting
SUSTOL (granisetron) Injection, extended release, which utilizes Heron’s proprietary Biochronomer drug delivery technology, is Heron’s novel, long-acting formulation of granisetron for the prevention of chemotherapy-induced nausea and vomiting (CINV). Granisetron, an FDA-approved 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist was selected due to its broad use by physicians based on a well-established record of safety and efficacy. SUSTOL has been shown to maintain therapeutic drug levels of granisetron for five days with a single subcutaneous injection. SUSTOL is being developed for the prevention of both acute (day 1 following the administration of chemotherapy agents) and delayed (days 2-5 following the administration of chemotherapy agents) CINV associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC). While other 5-HT3 antagonists are approved for the prevention of CINV, SUSTOL is the first agent in the class to demonstrate efficacy in reducing the incidence of delayed CINV in patients receiving HEC, a major unmet medical need, in a randomized Phase 3 study.

Affecting 70-80% of patients undergoing chemotherapy, CINV is one of the most debilitating side effects of such treatments, often attributed as a leading cause of premature discontinuation of cancer treatment. 5-HT3 receptor antagonists have been shown to be among the most effective and preferred treatments for CINV. However, an unmet medical need exists for patients suffering from CINV during the delayed phase, which occurs on days 2-5 following the administration of chemotherapy agents. Only one 5-HT3 receptor antagonist is approved for the prevention of delayed CINV associated with MEC, and no 5-HT3 receptor antagonists are approved for prevention of delayed CINV associated with HEC.

SUSTOL was the subject of a recently completed, multi-center, placebo-controlled, Phase 3 clinical study in patients receiving HEC regimens known as MAGIC. The MAGIC study evaluated the efficacy and safety of SUSTOL as part of a three-drug regimen with the intravenous (IV) neurokinin-1 (NK1) receptor antagonist fosaprepitant and the corticosteroid dexamethasone. The MAGIC study, which was conducted entirely in the U.S. using the 2011 ASCO (Free ASCO Whitepaper) guidelines for classification of emetogenic potential, is the only Phase 3 CINV prophylaxis study in a HEC population performed to date to use the currently recommended, standard-of-care, three-drug regimen as a comparator: a 5-HT3 receptor antagonist, fosaprepitant, and dexamethasone. The study’s primary endpoint was achieved. Specifically, the percentage of patients who achieved a Complete Response in the delayed phase was significantly higher in the SUSTOL arm compared with the comparator arm (p = 0.014). Adverse events reported in the study were generally mild to moderate in severity and of short duration, with the most common being injection site reactions (ISRs). In July 2015, Heron resubmitted its New Drug Application (NDA) for SUSTOL to the U.S. Food and Drug Administration (FDA), and the FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of January 17, 2016. SUSTOL has not been approved by the FDA or any other regulatory authority.

On September 28, 2015 DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported that Jeffrey Bacha, president and CEO, will present at VirtualInvestorConferences.com on Thursday, October 1, 2015, at 10:00 a.m. EDT (Press release, DelMar Pharmaceuticals, SEP 28, 2015, View Source [SID:1234507587]).

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DATE: Thursday, October 1, 2015
TIME: 10:00 a.m. EDT
LINK: View Source

As part of his presentation, Mr. Bacha will present a corporate overview, including recent progress of DelMar’s Phase II clinical trial of VAL-083 (dianhydrogalactitol) for the treatment of refractory glioblastoma multiforme (GBM) and future plans to initiate clinical trials with VAL-083 as a potential treatment for non-small cell lung cancer (NSCLC) and other solid tumors in collaboration with Guangxi Wuzhou Pharmaceutical (Group) Co., Ltd.

DelMar is conducting a multicenter Phase I/II clinical study with VAL-083 in patients with recurrent GBM. Data from the Phase I dose-escalation portion of the trial was presented at ASCO (Free ASCO Whitepaper). Dose limiting toxicity was observed at a dose of 50mg/m2/day; no drug-related severe adverse events were reported and myelosuppression was mild at doses <40mg/m2/day. Preliminary analysis suggested a dose-dependent and clinically meaningful survival benefit in GBM patients whose tumors had progressed following standard treatment with temozolomide, radiotherapy, bevacizumab and a range of salvage therapies.

The Company recently presented an update from the GBM clinical study at GBM2015 on a sub-group analysis for patients receiving up to 5 mg/m2 daily x 3 every 21 days (low dose) versus those patients receiving 30mg/m2 or 40mg/m2 (high dose) of VAL-083. In this analysis VAL-083 demonstrates dose-response and survival benefit in GBM patients failing standard front-line therapy and bevacizumab.

VirtualInvestorConferences.com is a live, interactive online event where investors are invited to ask the company questions in real-time – both in the presentation hall as well as the association’s "virtual trade booth." If attendees are not able to join the event live on the day of the conference, an on-demand archive will be available for 90 days. It is recommended that investors pre-register to save time and receive event updates.

A link to VirtualInvestorConferences.com event will also be available by accessing the DelMar’s IR Calendar in the Investors section of the Company’s website (www.DelMarPharma.com).

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About VAL-083
VAL-083 is a "first-in-class," small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated safety and efficacy in treating a number of cancers including lung, brain, cervical, ovarian tumors and leukemia. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia (CML) and lung cancer and has received orphan drug designation in Europe and the U.S. for the treatment of gliomas.

DelMar is currently studying VAL-083 in a multi-center Phase I/II clinical trial for patients with refractory GBM in accordance with the protocol that has been filed with the U.S. Food and Drug Administration (FDA) at five clinical centers in the United States: Mayo Clinic (Rochester, MN); UCSF (San Francisco, CA) and three centers associated with the Sarah Cannon Cancer Research Institute (Nashville, TN, Sarasota, FL and Denver, CO). As a potential treatment for glioblastoma, VAL-083’s mechanism of action appears to be unaffected by the expression of MGMT, a DNA repair enzyme that is implicated in chemotherapy resistance and poor outcomes following front-line treatment with Temodar (temozolomide).

On September 28, 2015 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, reported that data from two EU treatment centers supporting treatment of patients with liver metastases from ocular melanoma with the Delcath Hepatic CHEMOSAT Delivery System (CHEMOSAT) will be presented as a poster at the European Cancer Congress (ECCO) annual meeting, being held in Vienna, Austria from September 25-29, 2015 (Press release, Delcath Systems, SEP 28, 2015, View Source;p=RssLanding&cat=news&id=2090858 [SID:1234507586]).

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The study entitled, "Treating Unresectable Liver Metastases of Uveal Melanoma with (Percutaneous) Isolated Hepatic Perfusion with Melphalan: Results from Two Experienced Centers," by E.M. De Leede, M.C. Burgmans, et al., was a retrospective study conducted by investigators at Leiden University Medical Center (LUMC) and Erasmus Medical Center (EMC) in the Netherlands. Investigators compared patients with uveal (ocular) melanoma liver metastases treated with isolated hepatic perfusion (IHP), an open surgical procedure that can be performed only once, with patients treated with repeatable percutaneous hepatic perfusion (PHP) using the CHEMOSAT system with an aim to treat patients twice with a six week interval. Treatment characteristics, complications, toxicity, progression free and overall survival of both therapeutic approaches were analyzed. Both IHP and PHP treatments were performed with melphalan.

In the IHP cohort (30 patients treated between March 1999 and April 2009) progression free survival was 6 months and recurrence was mainly in the liver, and overall survival was 10 months. In the PHP cohort (9 patients who received 15 PHP treatments since February 2014), the maximum follow-up period was 14 months. Eight patients are still alive, seven without progression of disease. A decrease in red and white blood cell count and thrombocytes after the procedure was observed, and 3 patients needed blood transfusions or platelet infusion. Treatment was overall well tolerated. Investigators concluded that "percutaneous hepatic perfusion appears to be an effective and safe procedure in selected patients with unresectable liver metastases of colorectal cancer or uveal melanoma and can be repeated."

"With eight out of nine patients still alive at 14 months in this retrospective analysis, this is an encouraging signal for PHP and we look forward to seeing the final data," said Jennifer Simpson, Ph.D., MSN, CRNP, President and CEO of Delcath Systems. "This study is the first of several scheduled posters on the clinical merits of CHEMOSAT to be presented at major medical meetings this fall. We expect this growing body of clinical data will advance the continued adoption of CHEMOSAT in Europe and will support our ongoing reimbursement efforts in those territories."

The abstract of this study is available on the ECCO 2015 website.

On September 28, 2015 Array BioPharma’s (Nasdaq: ARRY) reported clinical trial results from its wholly-owned MEK inhibitor, binimetinib, and BRAF inhibitor, encorafenib, this weekend at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper)’s (ESMO) (Free ESMO Whitepaper) annual European Cancer Conference (ECC) (Press release, Array BioPharma, SEP 28, 2015, View Source;p=RssLanding&cat=news&id=2090805 [SID:1234507585]). At the meeting, preliminary data were shared from both a Phase 2 combination trial of binimetinib and encorafenib in BRAF-mutant melanoma patients (LOGIC2) and a Phase 1b/2 combination trial of binimetinib and ribociclib (Novartis, LEE011), a CDK4/6 inhibitor in NRAS-mutant melanoma patients.

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BRAF-mutant Melanoma Preliminary Results

LOGIC2 is an ongoing 140-patient, two-part study designed to explore the safety and activity of novel triplet combinations in BRAF-mutant melanoma. In part 1, patients are treated with the combination of binimetinib and encorafenib until disease progression. Based on the results of molecular profiling at that time, each patient is assigned to one of four arms containing a triplet combination of binimetinib, encorafenib and a third targeted therapy. Results from part 1 of the study are reported separately for patients who have previously received a BRAF and/or MEK inhibitor versus those who were initially naive to BRAF and MEK inhibitor treatment.

In part 1, patients are treated with binimetinib 45 mg twice daily (BID) and encorafenib 450 mg once daily (QD), the same doses evaluated in the ongoing Phase 3 COLUMBUS trial. In the BRAF/MEK-naive group (n=40), the interim overall response rate (confirmed and unconfirmed complete response or partial response) was 68%, with a 6-month progression-free survival estimate of 79%. Of note, 96% of patients in this group continued to receive study treatment as of the data cutoff. Preliminary data from all patients in the study (n=89) also indicate that the combination of binimetinib and encorafenib showed good tolerability with a 12% incidence of pyrexia and little to no rash or photosensitivity. These results indicate that the combination of binimetinib and encorafenib show encouraging clinical activity and an emerging differentiated tolerability profile relative to other MEK/BRAF inhibitor combinations.

"MEK and BRAF combination therapy is now established as the optimal molecularly targeted approach for BRAF mutant melanoma patients," said Reinhard Dummer, M.D., investigator, University Hospital Zurich. "In this study, the combination of encorafenib and binimetinib demonstrated robust clinical activity, consistent with results from other BRAF/MEK inhibitor combinations, but with a potentially improved and differentiated safety profile."

NRAS-mutant Melanoma Interim Results

A Phase 1b/2 study of binimetinib in combination with ribociclib showed promising preliminary antitumor activity in NRAS-mutant melanoma patients. Results were shared from 45 patients enrolled in the dose escalation portion of the study, which included two dosing schedules (28-day or 21-day cycles). For the 28-day dosing schedule, patients received continuous twice daily dosing of binimetinib while receiving ribociclib for 21 days per 28 day cycle. For the 21-day schedule, both agents were delivered for 14 days of a 21 day cycle.

For patients receiving the combination on a 28-day cycle (n=22), the Objective Response Rate (ORR, confirmed and unconfirmed complete or partial responses) was 41%, the Disease Control Rate (DCR, confirmed and unconfirmed complete or partial responses and stable disease) was 82% with a median Progression Free Survival (mPFS) of 6.7 months. Furthermore, the ORR was 56% (n=9) for patients receiving dose level 1 of the 28-day schedule consisting of binimetinib 45 mg BID and the lowest dose of ribociclib (200 mg QD), indicating that robust activity can be achieved with this dose and schedule. Common treatment-related adverse events included elevated creatine phosphokinase (CPK), skin and gastrointestinal events. Investigation of an alternative 21-day schedule is ongoing.

"Among metastatic melanoma patients, the presence of an NRAS-mutation is a predictor of poor prognosis, and for this subgroup of patients, there are currently no approved targeted therapies," said Carla van Herpen, M.D., Ph.D., Radboud University Medical Center, Nijmegen, The Netherlands. "Simultaneous inhibition of MEK and CDK4/6 protein kinases could suppress the activation of two major signaling pathways associated with NRAS mutations and may provide additive, or synergistic, activity versus single-agent therapy."

About Melanoma

Melanoma is the fifth most common cancer among men and the seventh most common cancer among women in the United States, with almost 74,000 new cases and nearly 10,000 deaths from the disease projected in 2015. BRAF and NRAS mutations occur in approximately 40% to 60% and 15% to 20%, respectively, of patients with melanoma. When melanoma is diagnosed early, it is generally a curable disease. However, when it spreads to other parts of the body, it is the deadliest and most aggressive form of skin cancer. A person with metastatic melanoma typically has a short life expectancy with only approximately 15% of patients surviving for five years following diagnosis of metastatic disease.

About BRAF, MEK, Binimetinib and Encorafenib

Raf and MEK are key protein kinases in the RAS/RAF/MEK/ERK pathway, which regulates several key cellular activities including proliferation, differentiation, migration, survival and angiogenesis. Inappropriate activation of this pathway has been shown to occur in many cancers, such as non-small cell lung cancer, melanoma, colorectal and thyroid cancers. Binimetinib is a small molecule MEK inhibitor and encorafenib is a small molecule BRAF inhibitor, both of which target key enzymes in this pathway. Three Phase 3 trials in advanced cancer patients continue to advance: NRAS-mutant melanoma (NEMO, with binimetinib), low-grade serous ovarian cancer (MILO, with binimetinib) and BRAF-mutant melanoma (COLUMBUS, with binimetinib and encorafenib). The NEMO and COLUMBUS Part 1 studies completed enrollment in April 2015. NRAS-mutant melanoma represents the first potential indication for binimetinib, with a projected regulatory filing estimated in the first half of 2016. Array also projects a regulatory filing of binimetinib in combination with encorafenib in BRAF melanoma in 2016.

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On September 28, 2015 ArQule, Inc. (NASDAQ:ARQL) reported preliminary results for the ongoing phase 1b expansion study in oncology for ARQ 092, an orally available selective pan-AKT inhibitor (Press release, ArQule, SEP 28, 2015, View Source [SID:1234507584]). The results were presented at the 2015 ESMO (Free ESMO Whitepaper) European Cancer Congress on September 27th, 2015.

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Thus far 25 patients have been treated in the study, and four partial responses (PRs) have been observed. These include two patients with the AKT1 E17K mutation and one patient with the PIK3CA H1047R mutation. Mutation status for a fourth patient could not be determined. Of the four PRs, two were observed in follicular lymphoma, one in breast cancer and one in endometrial cancer. The poster presentation can be accessed in the "Investor and Media" section of our website, www.arqule.com, under "Recent Data Presentations."

The phase 1b study follows completion of the phase 1a dose escalation portion of the trial that enrolled 82 patients and tested various dosages and dose regimens. In the phase 1a trial after one PR was observed in a patient with chronic lymphocytic lymphoma, the study was expanded to phase 1b with a focus on lymphoma, endometrial cancer and tumors harboring AKT (AKT1 E17K) or PI3K (PIK3CA H1047R) mutations.

"The preliminary results of the phase 1b expansion cohort are very encouraging," said Dr. Brian Schwartz, Head of Research and Development and Chief Medical Officer at ArQule. "The observation of four PRs in the 25 patients we have enrolled thus far validate our strategy to focus the trial on specific cancers with the AKT and PI3K mutations. We will continue to explore ARQ 092 in both cancer and rare diseases harboring these mutations."

ArQule continues to enroll patients in the phase 1b study while assessing next steps for ARQ 092 in oncology. In parallel, ArQule collaborators at the National Institute of Health (NIH) received approval of the Investigational New Drug (IND) application to begin a phase 1 trial with ARQ 092 in Proteus syndrome, a rare disease that is caused by a mutation of the AKT1 gene.

About ARQ 092 and the AKT Pathway

ARQ 092 is an orally available, selective small molecule inhibitor of the AKT kinase. The AKT pathway when abnormally activated is implicated in multiple oncogenic processes such as cell proliferation and apoptosis. This pathway has emerged as a target of potential therapeutic relevance for compounds that inhibit its activity, which has been linked to a variety of cancers as well as to select non-oncology indications.

ARQ 092, the lead compound in ArQule’s AKT program, has completed Phase 1a clinical testing and has advanced into Phase 1b expansion testing in cohorts of patients with endometrial cancer, lymphoma and tumors harboring either AKT or PI3K mutations. A number of next-generation compounds in the Company’s AKT program are in early to late stages of pre-clinical development.