On November 17, 2015 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that it will present eight posters at the 2015 San Antonio Breast Cancer Symposium (SABCS) being held Dec. 8 to 12, 2015 in San Antonio, Texas (Press release, Myriad Genetics, NOV 17, 2015, View Source [SID:1234508272]).

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"Myriad is committed to bringing transformative molecular diagnostics to people with cancer. Our data at SABCS showcase our expanding portfolio of companion diagnostics and their potential to help personalize treatments for people with breast cancer," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetic Laboratories. "We’re also excited about several new studies that highlight the ability of our myRisk Hereditary Cancer test to identify patients at risk for hereditary cancers."

A list of the Myriad presentations at SABCS is below. Follow Myriad on Twitter via @MyriadGenetics and stay informed about symposium news and updates by using the hashtag #SABCS15.

myChoice HRD Poster Presentations

Title: The role of germline BRCA status and Homologous Recombination Deficiency and response to neoadjuvant weekly paclitaxel followed by anthracycline-based chemotherapy.
Date: Thursday, Dec. 10, 2015: 5:00 to 7:00 p.m. CT.
Location: Poster P3-07-29.

Title: Homologous recombination deficiency (HRD) as a predictive biomarker of response to preoperative systemic therapy (PST) in TBCRC008 comprising a platinum in HER2-negative primary operable breast cancer.
Date: Thursday, Dec. 10, 2015: 5:00 to 7:00 p.m. CT.
Location: Poster P3-07-13.

Title: Homologous recombination deficiency (HRD) as a predictive biomarker of response to neoadjuvant platinum-based therapy in patients with triple negative breast cancer (TNBC); A pooled analysis.
Date: Thursday, Dec. 10, 2015: 5:00 to 7:00 p.m. CT.
Location: Poster P3-07-12.
myRisk Hereditary Cancer Poster Presentations

Title: Predisposing germline mutations in an unselected academic breast cancer (BC) cohort.
Date: Wednesday, Dec. 9, 2015: 5:00 to 7:00 p.m. CT.
Location: Poster P1-08-07.

Title: The patient experience in a prospective trial of multiple-gene panel testing for cancer risk.
Date: Thursday, Dec. 10, 2015: 7:30 to 9:00 a.m. CT.
Location: Poster P2-09-07.

Title: Interim analysis of multiplex gene panel testing for inherited susceptibility to breast cancer.
Date: Friday, Dec. 11, 2015: 5:00 to 7:00 p.m. CT.
Location: Poster Discussion PD7-01.

Title: Multiplex Identification of genetic etiologies among women with bilateral breast cancer using a 25-gene hereditary cancer panel.
Date: Friday, Dec. 11, 2015: 5:00 to 7:00 p.m. CT.
Location: Poster Discussion PD7-02.

Title: Characterization of Li-Fraumeni syndrome diagnosed using a 25-gene hereditary cancer panel.
Date: Friday, Dec. 11, 2015: 5:00 to 7:00 p.m. CT.
Location: Poster Discussion PD7-03.

For more information about these presentations, please visit the SABCS website at View Source

On November 17, 2015 Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported that data investigating the use of KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, in advanced non-small cell lung cancer, melanoma, classical Hodgkin lymphoma, multiple myeloma, and ER-positive/HER2-negative breast cancer will be presented at four medical congresses through the end of this year (Press release, Merck & Co, NOV 17, 2015, View Source [SID:1234508270]). In total, data from more than 30 abstracts will be presented at the Society for Melanoma Research (SMR) 2015 Congress in San Francisco, Nov. 18 – 21; the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, Florida, Dec. 5 – 8; the San Antonio Breast Cancer Symposium (SABCS), Dec. 8 – 12; and the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia 2015 Congress in Singapore, Dec. 18 – 21. By the end of 2015, data on the anti-tumor activity of KEYTRUDA will have been presented across more than 20 tumor types.

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"The field of immuno-oncology holds great potential across a broad spectrum of cancers," said Dr. Roy Baynes, senior vice president and head of global clinical development, Merck Research Laboratories. "Data for KEYTRUDA being presented at these scientific meetings include a first-time comparison to chemotherapy in advanced non-small cell lung cancer, novel combination data in advanced melanoma as well as first-time data in two additional tumor types, namely multiple myeloma and hormone receptor positive breast cancer, further demonstrating our deep commitment to advancing cancer treatment."

The KEYTRUDA clinical development program to date includes patients with more than 30 tumor types in more than 160 clinical trials, including more than 80 trials that combine KEYTRUDA with other cancer treatments.

A select list of KEYTRUDA data to be presented at these meetings includes:

SMR (data to be presented include three late breaking oral presentations and multiple posters on KEYTRUDA monotherapy)

Late Breaker Oral Presentation: Preliminary Data From a Phase 1/2 Study of Epacadostat (INCB024360) with Pembrolizumab as First-Line Treatment in Patients with Advanced/Metastatic Melanoma. O. Hamid. Saturday, Nov. 21, 2:50 p.m. PST. Location: Salon 9-15 (San Francisco Marriott Marquis).

Late Breaker Oral Presentation: Primary Analysis of MASTERKEY-265 Phase 1b Study of Talimogene Laherparepvec (T-VEC) and Pembrolizumab (pembro) for Unresectable Stage IIIB-IV Melanoma. G. Long. Saturday, Nov. 21, 3:20 p.m. PST. Location: Salon 9-15 (San Francisco Marriott Marquis).

Late Breaker Oral Presentation: KEYNOTE-029: Pembrolizumab (pembro) + Low-Dose Ipilimumab (ipi) For Advanced Melanoma. G. Long. Saturday, Nov. 21, 2:00 p.m. PST. Location: Salon 9-15 (San Francisco Marriott Marquis).
For more information about this congress, including a complete list of abstract titles, please visit the SMR 2015 website at www.melanomacongress.com.

ASH (data to be presented include four oral presentations and one poster presentation, including updated findings in classical Hodgkin lymphoma and first-time findings in multiple myeloma)

(Abstract #505) Oral Presentation: Pembrolizumab in Combination with Lenalidomide and Low-Dose Dexamethasone for Relapsed/Refractory Multiple Myeloma (RRMM): Keynote-023. J. San Miguel. Monday, Dec. 7, 7:00 a.m. EST. Location: Hall E1 (Orange County Convention Center).

(Abstract #584) Oral Presentation: PD-1 Blockade With Pembrolizumab in Patients With Classical Hodgkin Lymphoma After Brentuximab Vedotin Failure: Safety, Efficacy, and Biomarker Assessment. P. Armand. Monday, Dec. 7, 10:45 a.m. EST. Location: Hall E2 (Orange County Convention Center).

For more information about this congress, including a complete list of abstract titles, please visit the ASH (Free ASH Whitepaper) Annual Meeting website at www.hematology.org/Annual-Meeting.

SABCS (data to be presented include one oral presentation and three poster presentations, including first-time findings in ER-positive/HER2-negative breast cancer)

(Abstract #S5-07) Oral Presentation: Preliminary Efficacy and Safety of Pembrolizumab (MK-3475) in Patients with PD-L1–positive, Estrogen Receptor-positive (ER+)/HER2-negative Advanced Breast Cancer Enrolled in KEYNOTE-028. H. Rugo. Friday, Dec. 11, 11:00 a.m. CST. Location: Hall D (Henry B. Gonzalez Convention Center).
For more information about this congress, including a complete list of abstract titles, please visit the SABCS website at www.sabcs.org.

ESMO Asia (data to be presented include one oral presentation featured in the Presidential Symposium, one proffered paper presentation and seven poster presentations, including data comparing KEYTRUDA to chemotherapy in advanced non-small cell lung cancer)

(Abstract #LBA3) Presidential Symposium: KEYNOTE-010: Phase 2/3 Study of Pembrolizumab (MK-3475) vs Docetaxel for PD-L1–Positive NSCLC After Platinum-Based Therapy. R. Herbst. Sunday, Dec. 20, 5:00 p.m. SGT. Location: Hall 406 (Suntec Convention & Exhibition Centre).

(Abstract #315O) Proffered Paper Presentation: Antitumor Activity and Safety of Pembrolizumab in Patients with PD-L1-positive Nasopharyngeal Carcinoma: Interim Results From a Phase 1b Study. C. Hsu. Friday, Dec. 18, 2:50 p.m. SGT. Location: Hall 332 (Suntec Convention & Exhibition Centre).

For more information about this congress, including a complete list of abstract titles, please visit the ESMO (Free ESMO Whitepaper) Asia 2015 congress website at View Source

About KEYTRUDA (pembrolizumab) Injection 100 mg

KEYTRUDA is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

KEYTRUDA is indicated in the United States at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA is also indicated at the same dosing for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. These indications are approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for these indications may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Selected Important Safety Information for KEYTRUDA (pembrolizumab)

Pneumonitis, including fatal cases, occurred in patients receiving KEYTRUDA. Pneumonitis occurred in 12 (2.9%) of 411 melanoma patients, including Grade 2 or 3 cases in 8 (1.9%) and 1 (0.2%) patients, respectively, receiving KEYTRUDA. Pneumonitis occurred in 19 (3.5%) of 550 patients with NSCLC, including Grade 2 (1.1%), 3 (1.3%), 4 (0.4%), or 5 (0.2%) pneumonitis in patients, receiving KEYTRUDA. Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Colitis (including microscopic colitis) occurred in 4 (1%) of 411 patients with melanoma, including Grade 2 or 3 cases in 1 (0.2%) and 2 (0.5%) patients, respectively, receiving KEYTRUDA. Colitis occurred in 4 (0.7 %) of 550 patients with NSCLC, including Grade 2 (0.2%) or 3 (0.4%) colitis in patients receiving KEYTRUDA. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Hepatitis occurred in patients receiving KEYTRUDA. Hepatitis (including autoimmune hepatitis) occurred in 2 (0.5%) of 411 patients with melanoma, including a Grade 4 case in 1 (0.2%) patient, receiving KEYTRUDA. Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hypophysitis occurred in 2 (0.5%) of 411 patients with melanoma, including a Grade 2 case in 1 and a Grade 4 case in 1 (0.2% each) patient, receiving KEYTRUDA. Hypophysitis occurred in 1 (0.2 %) of 550 patients with NSCLC, which was Grade 3 in severity. Monitor patients for signs and symptoms of hypophysitis (including hypopituitarism and adrenal insufficiency). Administer corticosteroids and hormone replacement as indicated. Withhold KEYTRUDA for Grade 2 and withhold or discontinue for Grade 3 or Grade 4 hypophysitis.

Hyperthyroidism occurred in 5 (1.2%) of 411 patients with melanoma, including Grade 2 or 3 cases in 2 (0.5%) and 1 (0.2%) patients, respectively, receiving KEYTRUDA. Hypothyroidism occurred in 34 (8.3%) of 411 patients with melanoma, including a Grade 3 case in 1 (0.2%) patient, receiving KEYTRUDA. Hyperthyroidism occurred in 10 (1.8%) of 550 patients with NSCLC, including Grade 2 (0.7%) or 3 (0.3%). Hypothyroidism occurred in 38 (6.9%) of 550 patients with NSCLC, including Grade 2 (5.5%) or 3 (0.2%). Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of thyroid disorders. Administer replacement hormones for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 hyperthyroidism.

Type 1 diabetes mellitus, including diabetic ketoacidosis, has occurred in patients receiving KEYTRUDA. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer anti-hyperglycemics in patients with severe hyperglycemia.

Nephritis occurred in patients receiving KEYTRUDA. Nephritis occurred in 3 (0.7%) patients with melanoma, consisting of one case of Grade 2 autoimmune nephritis (0.2%) and two cases of interstitial nephritis with renal failure (0.5%), one Grade 3 and one Grade 4. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 nephritis.

Other clinically important immune-mediated adverse reactions can occur. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement of the adverse reaction to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following steroid taper. Permanently discontinue KEYTRUDA for any severe or Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

Across clinical studies with KEYTRUDA, the following clinically significant, immune-mediated adverse reactions have occurred: bullous pemphigoid and Guillain-Barré syndrome. The following clinically significant, immune-mediated adverse reactions occurred in less than 1% of patients with melanoma treated with KEYTRUDA: exfoliative dermatitis, uveitis, arthritis, myositis, pancreatitis, hemolytic anemia, and partial seizures arising in a patient with inflammatory foci in brain parenchyma. The following clinically significant, immune-mediated adverse reactions occurred in less than 1% of 550 patients with NSCLC treated with KEYTRUDA: rash, vasculitis, hemolytic anemia, serum sickness, and myasthenia gravis.

Infusion-related reactions, including severe and life-threatening reactions, have occurred in patients receiving KEYTRUDA. Monitor patients for signs and symptoms of infusion related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever. For severe or life-threatening reactions, stop infusion and permanently discontinue KEYTRUDA.

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. If used during pregnancy, or if the patient becomes pregnant during treatment, apprise the patient of the potential hazard to a fetus. Advise females of reproductive potential to use highly effective contraception during treatment and for 4 months after the last dose of KEYTRUDA.

Among the 411 patients with metastatic melanoma, KEYTRUDA was discontinued for adverse reactions in 9% of 411 patients. Adverse reactions, reported in at least two patients, that led to discontinuation of KEYTRUDA were: pneumonitis, renal failure, and pain. Serious adverse reactions occurred in 36% of patients. The most frequent serious adverse reactions, reported in 2% or more of patients, were renal failure, dyspnea, pneumonia, and cellulitis. The most common adverse reactions (reported in at least 20% of patients) were fatigue (47%), cough (30%), nausea (30%), pruritus (30%), rash (29%), decreased appetite (26%), constipation (21%), arthralgia (20%), and diarrhea (20%).

Among the 550 patients with metastatic NSCLC, KEYTRUDA was discontinued due to adverse reactions in 14% of patients. Serious adverse reactions occurred in 38% of patients. The most frequent serious adverse reactions reported in 2% or more of patients were pleural effusion, pneumonia, dyspnea, pulmonary embolism, and pneumonitis. The most common adverse reactions (reported in at least 20% of patients) were fatigue (44%), decreased appetite (25%), dyspnea (23%), and cough (29%).

No formal pharmacokinetic drug interaction studies have been conducted with KEYTRUDA.

It is not known whether KEYTRUDA is excreted in human milk. Because many drugs are excreted in human milk, instruct women to discontinue nursing during treatment with KEYTRUDA and for 4 months after the final dose.

Safety and effectiveness of KEYTRUDA have not been established in pediatric patients.

On November 17, 2015 DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported its financial results for the first quarter of the 2016 fiscal year ending September 30, 2015 (Press release, DelMar Pharmaceuticals, NOV 17, 2015, View Source [SID:1234508268]). The Company also provided a recap of recent corporate and clinical program highlights and an overview of expected near-term milestones.

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DelMar will host a conference call and live webcast for investors, analysts and other interested parties on Monday, November 23rd at 4:30 p.m. ET / 1:30 p.m. PT. During the call, management will provide a business update and discuss DelMar’s data presentation at the Society for Neuro-Oncology ("SNO") Annual meeting, which will be held November 19-22, 2015, at the Marriott Riverfront Hotel in San Antonio, Texas.

"We have made tremendous progress in executing our clinical development strategy with VAL-083 in refractory glioblastoma multiforme ("GBM") and identifying additional value drivers through non-clinical research that position us to expand our clinical development efforts into non-small cell lung cancer ("NSCLC") and other solid tumors. We have completed full enrollment of the Phase II expansion cohort in our refractory GBM clinical trial. The results of this study will be the basis for advancing VAL-083 into the planned registration-directed Phase II/III trial in refractory GBM," stated Jeffrey Bacha, president and CEO of DelMar Pharmaceuticals.

"Our clinical development expansion strategy for VAL-083 is proceeding as planned, and we expect to initiate new clinical studies in newly diagnosed GBM and NSCLC patients in the near future," added Mr. Bacha. "Our research collaborations continue to explore the mechanism of VAL-083 and these efforts have unlocked further opportunities for VAL-083 to address unmet medical needs by providing improved treatment options for patients with other tumor types, including ovarian cancer and difficult to treat sub-types of malignant pediatric brain tumors."

RECENT CORPORATE HIGHLIGHTS

We reported the completion of enrollment in the 14-patient expansion cohort of our Phase II clinical study of VAL-083 in patients with refractory GBM. In addition, we confirmed 40mg/m2 as the maximum tolerated dose ("MTD") for advancement into registration-directed clinical trials. This optimized dosing regimen delivers substantially higher doses compared to previous clinical trials conducted by the National Cancer Institutes ("NCI") in the United States. We believe that such higher doses may enhance the potential of VAL-083 to impact a patient’s tumor as well as to improve patient outcomes;

We reported the observation of a promising dose-response trend in the Phase I portion of the clinical trial. A subset analysis of patients in dose cohorts receiving ≥30mg/m2 had a median survival of approximately nine (9) months vs. approximately five (5) months in dose cohorts receiving <10mg/m2;

We reported additional non-clinical data supporting the favorable differentiation of VAL-083 versus standard of care in the treatment of GBM, non-small cell lung cancer and other solid tumors. We believe these data support the potential of VAL-083 to address the modern unmet medical needs in the treatment of a range of cancers, especially where other therapies have failed or are predicted to give sub-optimal outcomes;

We announced that the Mayo Clinic Cancer Center in Rochester, Minnesota and the Sarah Cannon Cancer Research Center at HealthOne, Denver, Colorado have had been added as new clinical trial sites in our ongoing, multicenter Phase I/II clinical trial study of VAL-083 in patients with refractory GBM. We now have five clinical sites involved in our study;

At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") – Advances in Pediatric Research: From Mechanisms and Models to Treatment and Survivorship, we presented data indicating that VAL-083 offers potential therapeutic alternatives in difficult-to-treat pediatric brain tumors;

At AACR (Free AACR Whitepaper)’s Advances in Ovarian Cancer Research: Exploiting Vulnerabilities Conference, we presented data supporting the effectiveness of VAL-083 against cisplatin-resistant ovarian cancers and raised the potential for VAL-083 as a treatment for ovarian cancer as a single-agent against platinum-resistant tumors or in combination with platinum-based chemotherapeutic regimens;
We announced we have launched a suite of online corporate communication channels to maintain ongoing and direct communication with shareholders and other interested parties. The Company hosts official digital portals on social medial channels including Twitter, LinkedIn, Facebook, Google+ and The Chairman’s Blog; and
We accessed additional capital to support our drug development and research programs through a registered stock offering for gross proceeds of $2.6 million.

"I am extremely pleased with our significant achievements in recent months. DelMar is well positioned for major developments as VAL-083 advances toward registration-directed studies for refractory GBM and into clinical trials for new indications. We anticipate that the VAL-083 program will continue to produce key data during the remainder of 2015 and throughout 2016," concluded Mr. Bacha.

EXPECTED NEAR-TERM MILESTONES

Present updated safety and efficacy data from the Phase II clinical trial in patients with refractory GBM at the Society for Neuro-Oncology Annual Meeting;

Initiate registration-directed Phase II/III clinical trials for VAL-083 as a new treatment option for refractory GBM in 2016;

Initiate new clinical trials, including front-line GBM and NSCLC;

Continue to pursue non-clinical research with VAL-083 as a potential treatment option for chemo-resistant cancers;

Establish collaboration discussions with leading investigators to advance VAL-083 into clinical studies as a potential treatment for children suffering from recurrent medulloblastoma or high grade gliomas;

Maximize the value of the VAL083 pipeline through potential partnering opportunities;

Continue to actively communicate DelMar’s progress to the investment and medical communities through presentations at peer-reviewed scientific meetings;

Continue to build the Company’s intellectual property portfolio; and

Continue to implement strategies to enable DelMar to meet qualifications to list its shares on a national stock exchange.

CONFERENCE CALL DETAILS

DelMar plans to host a conference call on Monday, November 23, 2015, at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time, to discuss quarterly results and the Company’s presentation at the Society for Neuro-Oncology annual meeting. For both "listen-only" participants and those who wish to take part in the question and answer portion of the call, the telephone Dial-in Number is (844) 303-8663 (toll-free) with Conference ID 81768802. A link to the webcast and slides will be available on the IR Calendar of the Investors section of the Company’s website at www.delmarpharma.com, and will be archived for 30 days.

SUMMARY OF FINANCIAL RESULTS FOR THE FIRST QUARTER OF FISCAL YEAR 2016 ENDED SEPTEMBER 30, 2015

For the three months ended September 30, 2015 the Company reported a net loss of $1,621,388, or a net loss per share of $0.04, compared to a net loss of $1,516,736, or a net loss per share of $0.04 for the three months ended September 30, 2014. In connection with the preparation of the Company’s financial statements for the three months ended September 30, 2015, and following discussion with a third party accounting consultant, it was determined that the certain common stock purchase warrants issued by the Company for placement agents’ services on March 6, 2013 (the "Placement Agent Warrants") should have been originally accounted for as a derivative liability in our audited financial statements. We determined that this was a material adjustment and as a result we have restated our audited June 30, 2015 and 2014 annual financial statements to report the impacts of the accounting error retroactive to March 2013.

"We strive to maintain the utmost integrity in all aspects of our business. Importantly, the reclassification of the Placement Agent Warrants does not affect our working capital or our operations as we seek to build shareholder value by implementing DelMar’s business plan," stated Mr. Bacha. "The fundamentals of our business, including developing our portfolio of clinical and non-clinical data supporting the potential of VAL-083 to address modern unmet medical needs in the treatment of cancer and the solid experience base of our development team, remain strong."

During the three months ended September 30, 2015 the Company completed a public offering of its shares and warrants for gross proceeds of $2.6 million.

Based on management’s current projections, the Company has enough capital to fund its operations into the third quarter of 2016.

FINANCIAL SUMMARY

The following represents selected financial information as of September 30, 2015. The Company’s financial information has been prepared in accordance with U.S. GAAP and this selected information should be read in conjunction with DelMar’s consolidated financial statements and Management’s Discussion and Analysis ("MD&A"), as filed.

DelMar’s financial statements as filed with the U.S. Securities Exchange Commission can be viewed on the company’s website at: View Source

Research and development

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 clinical activity against a range 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 recently announced the completion of enrollment in a Phase II clinical trial of VAL-083 in refractory GBM. 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 suggested 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 (

On November 17, 2015 Chugai Pharmaceutical Co., Ltd. (Chugai) (TOKYO: 4519) reported that regarding an application for patent term extension based on a market approval with respect to one of the regimens (i.e. 7.5 mg/kg every 3 weeks or more) in colorectal cancer, which has been disputed between Genentech Inc. (Genentech), a member of the Roche group, and Japan Patent Office (JPO), the Supreme Court decided to maintain the Intellectual Property High Court Grand Panel’s case decision that the trial decision of JPO to deny the application for patent term extension should be revoked (Press release, Chugai, NOV 17, 2015, View Source [SID:1234508259]).
The examination whether the patent term extension is acceptable or not will be proceeded again by JPO in light of this decision.

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Genentech is a patent holder and Chugai is the licensee of Avastin.

Chugai will continue to promote the proper use of Avastin.

The impact of the matter on our financial results is currently under scrutiny. Should any information necessary to be disclosed becomes clear in the future, it will be promptly disclosed.