On October 21, 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 the 14-patient expansion cohort of its Phase II clinical study of VAL-083 (dianhydrogalactitol) in patients with refractory glioblastoma multiforme (GBM) is now fully enrolled (Press release, DelMar Pharmaceuticals, OCT 21, 2015, View Source [SID:1234507753]).

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DelMar Pharmaceuticals Logo
"We are pleased to confirm that 14 patients have now received at least one course of treatment in the Phase II expansion of this study," stated Jeffrey Bacha, president & CEO of DelMar Pharmaceuticals. "The fact that we achieved full enrollment far more rapidly than projected, highlights the critical need for new therapies in the treatment of refractory GBM."

Patients enrolled in DelMar’s clinical trial have failed both front-line therapy with temozolomide and second-line Avastin and, in most cases, one or more salvage therapies.

"Currently available treatments unfortunately fail to offer any meaningful recourse to slow tumor progression or to extend life in the majority of GBM patients," Mr. Bacha continued. "We believe VAL-083 offers promise as a modern solution to the tremendous unmet medical need for a new therapy for GBM patients who have failed – or are unlikely to respond to – currently available treatments."

Data from the Phase I dose-escalation portion of the multicenter Phase I/II clinical study with VAL-083 in patients with recurrent GBM were presented at ASCO (Free ASCO Whitepaper) 2015. 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.

The Company also provided an update at the GBM2015 scientific meeting 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 (therapeutic dose) of VAL-083 in the study. The sub-group analysis supports 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.

DelMar commenced enrollment in the 14-patient expansion cohort for the trial in GBM near the end of the second quarter of 2015 at the University of California, San Francisco, the Mayo Clinic in Rochester, MN and three sites affiliated with the Sarah Cannon Cancer Research Institute in Nashville, TN, Sarasota, FL and Denver, CO. The purpose of the expansion cohort is to gain additional information about the safety and efficacy of VAL-083 at a 40mg/m2 dose prior to advancement into registration-directed Phase II/III clinical trials.

To further explore the therapeutic window of VAL-083, DelMar also enrolled three (3) patients an interim dose of 45mg/m2.

"Based on the well-tolerated nature of treatment observed at the 40mg/m2 dose compared to the dose limiting toxicity observed at 50mg/m2, our clinical advisors suggested that exploration of an interim dose at 45mg/m2 was warranted," stated Dr. Dennis Brown, DelMar’s Chief Scientific Officer. "Preliminary analysis of safety data from the 45mg/m2 cohort and from patients enrolled in the Phase II expansion cohort (at 40mg/m2) supports the 40mg/m2 dose as an appropriate dose for advancement into registration-directed clinical trials."

DelMar expects to provide ongoing updates of data during the Phase II trial at oncology and scientific meetings during the remainder of 2015 and into 2016.

Mr. Bacha concluded, "Given that we have now completed enrollment in the Phase II expansion phase of our current study, we remain on track to initiate Phase II/III registration-directed studies within the next nine to twelve months. The design and timing of initiation of the registration-directed clinical trial will depend on review of the data from this clinical study and discussions with the FDA and our clinical advisors."

Further information on the design of DelMar’s trial with VAL-083 as a treatment for GBM may be found on the company’s website at View Source

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 both as a single-agent and in combination with other treatments. 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 malignant gliomas.

DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by the expression of MGMT, a DNA repair enzyme that is implicated in chemotherapy resistance and poor outcomes in GBM patients following standard front-line treatment with Temodar (temozolomide).

DelMar’s Phase I/II clinical trial in refractory GBM is being conducted in accordance with a protocol that has been filed with the U.S. Food and Drug Administration (FDA). Patients have been enrolled 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).

In the Phase I dose-escalation portion of the study, VAL-083 was well tolerated at doses up to 40mg/m2 using a regimen of daily x 3 every 21 days. Adverse events were typically mild to moderate; no treatment-related serious adverse events reported at doses up to 40 mg/m2. Dose limiting toxicity (DLT) defined by thrombocytopenia (low platelet counts) was observed in two of six (33%) of patients at 50 mg/m2. Generally, DLT-related symptoms resolved rapidly and spontaneously without concomitant treatment, although one patient who presented with hemorrhoids received a platelet transfusion as a precautionary measure.

Sub-group analysis of data from the Phase I dose-escalation portion of the study suggests a dose-dependent and clinically meaningful survival benefit following treatment with VAL-083 in GBM patients whose tumors had progressed following standard treatment with temozolomide, radiotherapy, bevacizumab and a range of salvage therapies.

Patients in a low dose (<5mg/m2) sub-group had a median survival of approximately five (5) months versus median survival of approximately nine (9) months for patients in the therapeutic dose (30mg/m2 & 40mg/m2) sub-group following initiation of VAL-083 treatment. Increased survival was observed at 6, 9 and 12 months following initiation of treatment with VAL-083 in the therapeutic dose sub-group compared to the low dose sub-group.

Further details can be found at View Source

On October 20, 2015 Varian Medical Systems reported that increasing access to radiotherapy worldwide through greater investment could save millions of lives, according to The Lancet Oncology Commission’s report presented at the 2015 European Cancer Congress in Vienna, Austria, and published in The Lancet Oncology (Press release, InfiMed, OCT 20, 2015, View Source [SID:1234507742]).1 The Commission’s results were presented here yesterday at the 2015 annual meeting of the American Society for Radiation Oncology (ASTRO).

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Patient receives a radiotherapy treatment for cancer.
The Commission found that up to 60% of all cancer patients worldwide will need radiotherapy at some point in their treatment, but a lack of investment in radiotherapy services has severely limited access to radiotherapy treatments worldwide, especially in low-income and middle-income countries (LMIC).

LMIC have 80% of the global cancer burden but only 5% of the resources for cancer control, and in low-income countries, 90% of the population lack access to radiotherapy. Even in high income countries the numbers of radiotherapy facilities, equipment, and trained staff are inadequate.

Radiotherapy is important for managing most cancers, such as breast, lung, prostate, head and neck, and cervical cancers, which account for more than two-fifths of cases worldwide. In their report, the Commission details how a persistent underinvestment in radiotherapy globally has diminished access, and describes the substantial health and economic benefits of investing in radiotherapy.

With the number of new cancer cases expected to rise to 24.6 million by 2035, the Commission claims that increasing access to radiotherapy services in LMIC by scaling up radiotherapy capacity from current levels could lead to a saving of 27 million life years by 2035, over the lifetime of patients who receive this treatment.

In addition to saving human lives, providing full access to radiotherapy through investment could reduce the economic burden of cancer worldwide, which was $2 trillion in 2010. By 2035, full access to radiotherapy for all patients in LMIC could be achieved for as little as $97 billion, with economic benefits ranging from $278 billion to $365 billion over the next 20 years.

The Commission called for a long-term commitment to cancer care and treatment through the following actions:

80% of countries should have cancer plans that include radiotherapy by 2020.
By 2025, radiotherapy treatment capacity should be increased by 25% from 2015 capacity.
Each LMIC should have at least once cancer center by 2020.
LMIC should train 7,500 radiation oncologists; 20,000 radiation technologists; and 6,000 medical physicists by 2025.
LMIC should invest $46 billion by 2025 to establish radiotherapy infrastructure and training.
80% of LMIC should include radiotherapy services as part of their universal health coverage by 2020.
"The Lancet Commission has done an impressive job of demonstrating how increasing access to life-saving radiotherapy treatment makes sense not only for the health and well-being of our world community but economically as well," said Dow R. Wilson, president and CEO of Varian Medical Systems. "Congratulations on this important study, which will, we hope, lead to cancer programs that can help save lives around the world."

On October 20, 2015 Synta Pharmaceuticals Corp. (NASDAQ: SNTA) treported that the Company has decided to terminate the Phase 3 GALAXY-2 trial of ganetespib and docetaxel in the second-line treatment of patients with advanced non-small cell lung adenocarcinoma (Press release, Synta Pharmaceuticals, OCT 20, 2015, View Source;p=RssLanding&cat=news&id=2098806 [SID:1234507747]). Based on the review of a pre-planned interim analysis, the study’s Independent Data Monitoring Committee (IDMC) concluded that the addition of ganetespib to docetaxel is unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall survival compared to docetaxel alone. The IDMC noted that the combination of ganetespib and docetaxel was generally well tolerated in the study, with an adverse event profile consistent with previous studies combining these agents.

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GALAXY-2 is a Phase 3 global, randomized, multi-center trial. Synta continues to support enrollment in four additional large, randomized, multi-center investigator-sponsored studies, including: the GANNET53 trial of ganetespib and paclitaxel in ovarian cancer; the AML LI-1 trial of ganetespib with low dose cytarabine (Ara-C) in acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS); the AML18 trial of ganetespib with standard DA (daunorubicin and Ara-C) in AML and high-risk MDS; and the I-SPY 2 TRIAL of ganetespib and standard chemotherapy in women with newly diagnosed, locally advanced breast cancer.

"This disappointing outcome underscores the challenges of treating lung cancer in the second-line setting and determining the precise population for whom ganetespib may be most effective," said Chen Schor, President and Chief Executive Officer of Synta. "We thank the patients, caregivers and investigators who participated in GALAXY-2."

Mr. Schor continued: "Despite the outcome of this trial, and pending discussions with the relevant investigators, we will continue to support ongoing investigator-sponsored studies while we determine the appropriate path forward for ganetespib. We also look forward to advancing candidates from our HDC platform into the clinic. With the significant cash reserves we have in hand, our pipeline, our scientific internal leadership and network of advisors, we expect to undertake a comprehensive review of our strategy going forward."

Upon formal acceptance of the IDMC’s recommendation, Synta will communicate with regulatory authorities, and will notify study investigators that treatment with ganetespib should be discontinued in the GALAXY-2 trial.

On October 20, 2015 Nimbus Therapeutics, a biotechnology company focused on harnessing the power of computational chemistry to design breakthroughs for serious, underserved diseases, reported an exclusive worldwide license agreement with Genentech, a member of the Roche Group, to discover and develop small molecule inhibitors of interleukin-1 receptor-associated kinase 4 (IRAK4) (Press release, Nimbus Therapeutics, OCT 20, 2015, View Source [SID1234527306]).

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Under the terms of the agreement, Nimbus will receive an undisclosed upfront payment and is eligible to receive milestone payments based on achievement of certain predetermined milestones. In addition, Nimbus is eligible to receive royalties on sales of certain products resulting from the license agreement. Genentech will be responsible for all preclinical and clinical development, manufacturing and commercialization. Financial terms have not been disclosed.

"With its expertise, capabilities and global reach, Genentech is the best partner to rapidly advance these promising candidates to the clinic and, ultimately, bring new treatments to patients," said Don Nicholson, Chief Executive Officer of Nimbus.

"Genentech is dedicated to bringing forth treatments for patients with serious and life-threatening diseases," said James Sabry, Senior Vice President and Global Head of Genentech Partnering. "Nimbus’ unique approach to drug discovery will enhance our research and development programs for immunological disorders."

On October 19, 2015 Valeant Pharmaceuticals reported Third Quarter 2015 Financial results Results (Press release, Valeant, OCT 19, 2015, http://ir.valeant.com/investor-relations/news-releases/news-release-details/2015/Valeant-Pharmaceuticals-Reports-Third-Quarter-2015-Financial-Results/default.aspx [SID:1234507738]).

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2015 Third Quarter Results

Total Revenues of $2.8 billion; an increase of 36% over the prior year despite negative foreign exchange impact of $172 million
Same store sales organic growth of 13%; 5th consecutive quarter of > 10% organic growth, driven by:
Continued outperformance of U.S. businesses, particularly dermatology and contact lens
Strong results in China (23%), South Korea (15%) and Mexico (10%)
Total company growth was 8.2% volume and 4.4% price
U.S. branded pharmaceuticals growth was 18.8% volume and 15.2% price
Excluding the impact from genericization of Targretin Capsules during the quarter, same store sales organic growth would have been 14%

Impact from generic Xenazine expected fully in fourth quarter
Salix revenue was $461 million
Strong Xifaxan script uptake following IBS-D approval
Salix wholesaler inventory levels reduced from 3-3.5 months to 2-2.5 months
GAAP EPS $0.14; Cash EPS $2.74, an increase of 30% over prior year despite the negative foreign exchange impact of $0.13 versus the prior year
GAAP Operating Cash Flow $737 million, an increase of 19% over prior year; excluding the impact of foreign exchange, the increase was 26%
Adjusted Operating Cash Flow $865 million, an increase of 12% over prior year; excluding the impact of foreign exchange, the increase was 18%
Deals recently closed include Sprout, brodalumab, Synergetics and Amoun, which is expected to close later today

Fourth Quarter 2015 Guidance

Total Revenue increased to $3.25 – $3.45 billion from $3.2 – $3.4 billion
Cash EPS increased to $4.00 – $4.20 from $3.98 – $4.18

Full Year 2015 Guidance

Total Revenue increased to $11.0 – $11.2 billion from $10.7 – $11.1 billion,
Salix revenue expected to be ~$1.35 billion
Cash EPS increased to $11.67 – $11.87 from $11.50 – $11.80
Adjusted Cash Flow from Operations of greater than $3.35 billion
Same Store Sales Organic Growth of >10% for Q4 and FY 2015