On November 14, 2016 MabVax Therapeutics Holdings, Inc. (NASDAQ: MBVX), a clinical stage immuno-oncology drug development company, reported on progress from its two HuMab-5B1 antibody phase I programs evaluating the use of MVT-5873 as a therapeutic antibody and MVT-2163 as an immuno-PET imaging agent in patients with locally advanced and metastatic pancreatic cancer or other CA19-9 positive malignancies.

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MVT-5873 Interim Phase I Data in Pancreatic Cancer
The MVT-5873 phase I clinical trial initiated in February 2016 is designed to establish safety and determine the recommended phase II dose (RP2D) for MVT-5873 as both as monotherapy (Part 1 of the trial), and in combination with standard of care chemotherapy (Part 2) using nab-paclitaxel plus gemcitabine. Initiation of Part 2 requires establishing three safe dose levels for MVT-5873 as monotherapy in patients with relapsed or refractory locally advanced or metastatic pancreatic cancer. The Company reports that the safety of MVT-5873 has been established at three incremental dose levels by treating 16 patients at three clinical sites. While patients continue to be recruited to establish the RP2D, the Company also reports that Part 2 of the clinical trial is now open and will include patients with previously untreated pancreatic cancer receiving a standard of care chemotherapy as defined in the protocol.

To date, the study has consented 28 subjects with 3 in screening, 9 screen failures, and 16 subjects treated. Of the 16 patients treated, six continue to receive treatment. Patients can remain on therapy based on dose tolerability and investigator assessment of continued benefit including assessment of disease status using RECIST 1.1 criteria to evaluate tumor response rate and duration of response. Stable disease was noted for seven patients lasting from three months to eight months. The dosage safety levels established in Part 1 of the trial also support the dosage levels of MVT-5873 to be used in conjunction with the company’s MVT-2163 immuno-PET imaging agent and the MVT-1075 radioimmunotherapy product which is planned to begin phase I clinical evaluation early in 2017.

MVT-2163 Interim Phase I Data in Pancreatic Cancer
The MVT-2163 phase I trial was initiated in June of this year to evaluate the company’s next generation diagnostic PET imaging agent in patients with locally advanced or metastatic adenocarcinoma of the pancreas (PDAC) or other CA19-9 positive malignancies. MVT-2163 (89Zr-HuMab-5B1) combines the well-established PET imaging radiolabel Zirconium [89Zr] with the targeting specificity of MVT-5873. This trial is designed to establish safety, pharmacokinetics, biodistribution, and the amount of MVT-5873 to be used in co-administration to obtain optimized PET scan images. The company has demonstrated interim safety, pharmacokinetics, and biodistribution by completing the initial two cohorts of patients: the first cohort administered MVT-2163 alone and the second cohort administered MVT-2163 following a blocking dose of MVT-5873. The company reports that the initial PET images demonstrated target specificity by correlation with lesions identified by conventional computerized tomography (CT) scans. The biodistribution data obtained in the first two cohorts demonstrates improvement in PET images by pre-administration of MVT-5873, as has been observed with other antibody based PET agents. The company is actively recruiting patients and expects to establish the optimal co-administration dose of MVT-5873 early in 2017.

"Our strategy at the outset was to initiate these two clinical trials concurrently to address the key questions of safety and targeting specificity for the HuMab-5B1 antibody. We are highly encouraged by these promising early results from the MVT-5873 and MVT-2163 clinical trials," stated President and CEO J. David Hansen. He added, "We are moving ahead with the planned combination of MVT-5873 with a standard of care chemotherapy in a chemotherapy-naïve pancreatic cancer patient population and are looking forward to presenting these results next year. We are continuing to accrue patients in order to establish the RP2D for MVT-5873 as a monotherapy. In the MVT-2163 trial, dose escalation continues to confirm optimal dose and timing for the best PET scan image. Finally, the company remains on track for submitting the Investigational New Drug Application (IND) for MVT-1075 to the Food And Drug Administration (FDA) later this year, and plans to initiate the phase I trial of MVT-1075 in the first half of 2017 after receiving FDA authorization to proceed."

On November 14, 2016 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS), a clinical-stage company developing new therapeutics and molecular diagnostics that target the underlying mechanisms of cancer, reported unaudited financial results for the three months ended September 30, 2016 and reported on corporate developments (Press release, Aptose Biosciences, NOV 14, 2016, View Source;p=RssLanding&cat=news&id=2222358 [SID1234516605]). Unless specified otherwise, all amounts are in Canadian dollars.

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Net loss for the three months ended September 30, 2016 was $4.0 million ($0.31 per share) compared with $3.3 million ($0.27 per share) during the three months ended September 30, 2015. Total cash and cash equivalents at September 30, 2016 were $10.3 million.

"During the third quarter of this year we focused on collecting and delivering to the U.S. Food and Drug Administration (FDA) the manufacturing information required to get our clinical trial of APTO-253 for acute myeloid leukemia (AML) back on track, as returning APTO-253 to the clinic is a major event for the company and for patients with AML," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "Simultaneously, we advanced the development of CG’806, which we believe can be a transformational drug for patients with FLT3-driven AML and for patients with B cell malignancies driven by the Cys481Ser mutant of the BTK enzyme."

Corporate Highlights
During the quarter, Aptose submitted a formal response and data package to the FDA, providing responses to all of the questions cited in the clinical hold letter issued by the FDA. The response to the FDA was based on a prototype drug product that was developed and manufactured to demonstrate the root cause and the corrective actions taken by Aptose to deliver ultimately a drug product that meets FDA standards for the return to the clinic.

As announced in October, the FDA requested that Aptose provide the FDA with the Chemistry, Manufacturing and Control (CMC) package for the actual GMP drug substance and drug product intended to serve as the clinical supply for the trial.

Aptose has now manufactured a batch of APTO-253 drug product that is intended to serve as the clinical supply for the trial, and vials of this new drug product batch have been placed on an accelerated and long-term stability-testing program. Data generated from this drug product batch will comprise much of the CMC package that Aptose will provide to the FDA.

In parallel, Aptose’s clinical team has identified and prepared multiple new clinical sites for the Phase 1b trial of APTO-253. The clinical sites, at major cancer research and treatment centers in the U.S., will be prepared to start the study as soon as the company resumes trial activities and re-initiates dosing and enrollment after the approval by FDA to do so.

Aptose recently announced that new preclinical data for APTO-253 will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting, being held December 3-6, 2016 in San Diego, CA. The poster presentation, Inhibition of c-Myc By Apto-253 As an Innovative Therapeutic Approach to Induce Cell Cycle Arrest and Apoptosis in Acute Myeloid Leukemia, abstract # 1716, can be viewed at the ASH (Free ASH Whitepaper) conference website.

Aptose continued to profile the mechanistic properties and range of action of CG’806. This once daily, oral, first-in-class FLT3/BTK inhibitor demonstrates potent inhibition of mutant forms of FLT3 (including internal tandem duplication, or ITD, and mutations of the receptor tyrosine kinase domain), and the molecule is being positioned as a potential best-in-class therapeutic for patients with FLT3-driven AML. Likewise, CG’806 demonstrates potent, non-covalent inhibition of the Cys481Ser mutant of the BTK enzyme, suggesting the agent may be developed for CLL and MCL patients that are resistant/refractory/intolerant to covalent BTK inhibitors.
Financial Results
Net loss for the three months ended September 30, 2016 was $4.0 million ($0.31 per share) compared with $3.3 million ($0.27 per share) in the same period in the prior year. Net loss for the nine months ended September 30, 2016 was $14.7 million ($1.19 per share) compared with $10.2 million ($0.86 per share) during the nine months ended September 30, 2015.
Aptose utilized cash of $3.3 million in operating activities in the three months ended September 30, 2016 compared with $2.6 million during the three months ended September 30, 2015. For the nine months ended September 30, 2016 Aptose utilized cash of $12.4 million compared with $9.0 million in the nine months ended September 30, 2015. The cash utilized in the three months ended September 30, 2016 is higher than the three months ended September 30, 2015 due to a higher net loss as well as cash used to reduce accounts payable and accrual balances in the prior year period. The cash utilized in the nine months ended September 30, 2016 increased compared to the prior year period predominantly due to an increased net loss in the current year period.
Research and Development
Research and development expenses totaled $2.2 million in the three months ended September 30, 2016 compared to $1.7 million during the three months ended September 30, 2015 and totaled $7.8 million for the nine month period ended September 30, 2016 compared with $3.9 million in the same period in the prior year. Research and development costs consist of the following:
Components of research and development expenses:
Three months ended Nine months ended
September 30, September 30,
(in thousands) 2016 2015 2016 2015

Program costs $ 2,081 $ 1,633 $ 6,207 $ 3,750
CrystalGenomics Option Fee − − 1,294 −
Stock-based compensation 71 79 236 145
Depreciation of equipment 12 10 35 19
$ 2,164 $ 1,722 $ 7,772 $ 3,914
The increase in program costs in the three and nine months ended September 30, 2016 compared with the three and nine months ended September 30, 2015 is due to the following reasons:
Costs associated with the LALS/Moffitt collaboration developing epigenetic single molecule inhibitors of multiple targets, including the BET proteins, and other kinases for which no comparable expenses existed in the prior year periods;
Increased research and clinical operations headcount and related costs;
Formulation and manufacturing costs associated with APTO-253 and the root cause analysis of the filter clogging identified in November 2015; and
Increased Contract Research Organization costs related to consultants and advisors as Aptose works towards returning APTO-253 to the clinic.
As of November 2016, Aptose and Laxai Avanti Life Sciences (LALS) have, as part of their drug discovery partnership, generated novel compounds that inhibit both the bromodomain proteins and oncogenic kinases, while improving pharmaceutical properties that could serve as a basis for further optimization towards a lead preclinical candidate. However, due to a prioritization of development efforts, Aptose and LALS have suspended work on the program, and the collaboration with LALS has been terminated. During the hiatus of this program, Aptose and LALS may choose to resume the collaboration in the future.
During the nine months ended September 30, 2016, the Company paid US$1.0 million (CA$1.294 million) for an option fee related to the CG’806 technology. No comparable expense existed in the same period in the prior year.
Stock-based compensation was consistent in the three months ended September 30, 2016 compared with the three months ended September 30, 2015. While the number of option grants in the current year was higher than the prior year, the fair value of those grants was lower in the current year due to a lower stock price.
Stock-based compensation costs allocated to research and development increased in the nine months ended September 30, 2016 to reflect option grants to new employees hired in the second half of 2015 as the expense related to those grants was amortized 50% in the first 12 months.
General and Administrative
General and administrative expenses totaled $1.9 million in the three-month period ended September 30, 2016 compared to $2.2 million in the three months ended September 30, 2015. For the nine month period ended September 30, 2016, general and administrative expenses totaled $6.9 million compared with $7.5 million in the same period in the prior year. General and administrative expenses consist of the following:
Components of general and administrative expenses:
Three months ended Nine months ended
September 30, September 30,
(in thousands) 2016 2015 2016 2015

G&A expenses excluding salaries $ 733 $ 819 $ 2,688 $ 2,997
Salaries 858 838 2,656 2,348
Stock-based compensation 320 572 1,476 2,091
Depreciation of equipment 21 19 63 45
$ 1,932 $ 2,248 $ 6,883 $ 7,481
General and administrative expenses excluding salaries, decreased in the three months ended September 30, 2016 compared with the three months ended September 30, 2015. The decrease is primarily attributable to lower travel, legal and consulting costs associated with projects completed in the prior year offset by higher patent costs in the current year due to new programs acquired in late 2015 and 2016.
General and administrative expenses excluding salaries, decreased in the nine months ended September 30, 2016 compared with the nine months ended September 30, 2015. The decrease is the result of lower travel, consulting and legal costs in the current year related to transactions completed in the prior year as well as lower press release and filing costs associated with a lower cost service provider in the current year periods.
Salary charges in the three months ended September 30, 2016 were consistent with the prior year period as headcount was consistent year over year in the three month period.
Salary charges in the nine months ended September 30, 2016 increased in comparison with the nine months ended September 30, 2015 due to additional headcount in the first half of 2016 compared with the first half of 2015 as well as a higher average CA/US exchange rate which increased the cost of our US denominated salaries in the first six months of 2016 in comparison with the prior year.
Stock-based compensation decreased in the three months ended September 30, 2016 compared with the three months ended September 30, 2015 due to options granted in the current year having a lower valuation and therefore expense compared with options granted in the prior year.
Stock-based compensation decreased in the nine months ended September 30, 2016 compared with the nine months ended September 30, 2015 due to large option grants in April, June and July 2014 which vested 50% during the first year and therefore contribute to higher stock-based compensation expense during the first twelve month period captured in the prior year period.
Finance Expense
Finance expense for the three months ended September 30, 2016 totaled $nil compared with $8 thousand for the three months ended September 30, 2015. For the nine months ended September 30, 2016, finance expense totaled $138 thousand compared with $43 thousand for the same period in the prior year. Finance expense includes the following items:
Three months ended Nine months ended
September 30,
September 30,
(in thousands) 2016 2015 2016 2015
Interest expense $ − $ 8 $ − $ 43
Foreign exchange loss − − 138 −
$ − $ 8 $ 138 $ 43
Interest expense for the three and nine months ended September 30, 2015 relates to interest accrued at a rate of 10% on the remaining balance of convertible promissory notes issued in September 2013 as well as accretion expense related to the conversion feature of the notes. As the promissory notes were converted before September 2015, no interest expense was incurred in 2016.
Foreign exchange loss is the result of the fluctuation of exchange rates between US and Canadian dollars and the impact on our US dollar denominated cash balances.
Finance Income
Finance income totaled $79 thousand in the three months ended September 30, 2016 compared to $717 thousand in the three months ended September 30, 2015. For the nine months ended September 30, 2016, finance income totaled $92 thousand compared with $1.2 million in the same period in the prior year. Finance income includes the following items:
Three months ended Nine months ended
September 30, September 30,
(in thousands) 2016 2015 2016 2015
Interest income $ 12 $ 56 $ 92 $ 232
Foreign exchange gain 67 661 − 1,011
$ 79 $ 717 $ 92 $ 1,243
Interest income represents interest earned on our cash and cash equivalent and investment balances. Foreign exchange gains are the result of an increase in the value of US dollar denominated cash and cash equivalents balances during such periods due to a depreciation of the Canadian dollar compared to the US dollar.
Aptose Biosciences Inc.
Condensed Consolidated Interim Statements of Loss and Comprehensive Loss
(unaudited)
Three Three Nine Nine
months ended months ended months ended months ended
(amounts in 000’s of Canadian Dollars except for per common share data) Sept. 30, 2016 Sept. 30, 2015 Sept. 30, 2016 Sept. 30, 2015
REVENUE $ - $ - $ - $ -
EXPENSES
Research and development 2,164 1,722 7,772 3,914
General and administrative 1,932 2,248 6,883 7,481
Operating expenses 4,096 3,970 14,655 11,395
Finance expense – 8 138 43
Finance income (79 ) (717 ) (92 ) (1,243 )
Net financing (income) expense (79 ) (709 ) 46 (1,200 )
Net loss and comprehensive loss for the period 4,017 3,261 14,701 10,195
Basic and diluted loss per common share $ 0.31 $ 0.27 $ 1.19 $ 0.86
Weighted average number of common shares
outstanding used in the calculation of
basic and diluted loss per common share (000’s) 12,882 11,964 12,390 11,889
The press release, the financial statements and the management’s discussion and analysis for the quarter ended September 30, 2016 will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov/edgar.shtml

On November 14, 2016 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, reported financial results for the three and nine months ended September 30, 2016

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CASI PHARMACEUTICALS REPORTS THIRD QUARTER 2016 FINANCIAL RESULTS.

As of September 30, 2016, CASI had cash and cash equivalents of approximately $24.1 million.

CASI reported a net loss for the third quarter of 2016 of ($1.7 million), or ($0.03) per share. This compares with a net loss of ($1.6 million), or ($0.05) per share, for the same period last year. For the first nine months of 2016, the reported net loss was ($6.8 million), or ($0.15) per share as compared to ($5.5 million), or ($0.17) per share for the first nine months of 2015.

Commenting on these results, Sara B. Capitelli, CASI’s Vice President, Finance, said, "Our third quarter 2016 financial results were in line with expectations. Research and development expenses increased during the 2016 period compared with the previous year primarily due to costs associated with our ENMD-2076 fibrolamellar carcinoma trial which began in late 2015. As we continue to execute our regulatory, clinical and business development plan, we expect operating expenses to increase for the remainder of 2016."

Ken K. Ren, Ph.D., CASI’s Chief Executive Officer, stated, "I am pleased with our third quarter financial results. In October, we completed the last closing ($7.8 million) of our previously announced financing, and also completed an additional $3.0 million financing. Participants in the financing included our existing shareholders represented on our Board of Directors. In addition to a positive financial outlook, we look forward to further advancing our proprietary clinical candidate ENMD-2076, as well as MARQIBO, ZEVALIN and EVOMELA in China, and securing additional in-license assets to expand our pipeline. Proceeds from the recent financings will help accelerate these activities."

On November 14, 2016 Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) ("Cyclacel" or the "Company"), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, reported financial results and business highlights for the third quarter ended September 30, 2016 (Press release, Cyclacel, NOV 14, 2016, View Source [SID1234516611]).

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The Company’s net loss applicable to common shareholders for the third quarter ended September 30, 2016 was $3.0 million, or $0.86 per basic and diluted share, compared to net loss applicable to common shareholders of $2.8 million, or $0.95 per basic and diluted share for the third quarter ended September 30, 2015. As of September 30, 2016, cash and cash equivalents totaled $18.0 million.

"SEAMLESS, a Phase 3 study of oral sapacitabine capsules, represents one of the largest clinical trials conducted in elderly patients with AML who are unfit for or refused intensive chemotherapy. Following completion of follow-up at the beginning of the quarter, we have been conducting data validation operations," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "We are pleased to report that this process is nearing completion following which the database will be locked and transferred to our statistical analysis vendor. We anticipate reporting top line results late in the fourth quarter of 2016 or in early 2017."

"The collection and processing of SEAMLESS Phase 3 data represent many years of effort in our search to offer a new treatment regimen for this older patient population. We will soon analyze the data and determine whether the results warrant regulatory submissions," said Dr. Judy Chiao, VP, Clinical Development and Regulatory Affairs. "We are grateful to the patients, their families, the investigators and their teams for their valuable contributions to this study."

"During the quarter data presented at a pediatric cancer meeting demonstrated that CYC065, our second generation Cyclin Dependent Kinase (CDK) inhibitor, prolonged survival in MYCN-addicted neuroblastoma models. The data further validate the mechanism of CYC065 and provide a rationale for clinical investigation in neuroblastoma with MYCN amplification, a major oncogenic driver of this childhood cancer. MYC family proteins are important therapeutic targets in other oncology indications, including certain solid tumors, leukemias and lymphomas. Early clinical and preclinical data from our DNA damage response program suggest that our transcriptional CDK inhibitors may have a synergistic effect with other anticancer agents, including sapacitabine. We look forward to reporting new data from our ongoing clinical studies of sapacitabine and seliciclib in BRCA positive patients and of CYC065 in patients with solid tumors," continued Mr. Rombotis.

BUSINESS HIGHLIGHTS

SEAMLESS study

Phase 3 study of oral sapacitabine capsules alternating with intravenous decitabine compared to decitabine alone, as first-line treatment in patients aged 70 years or older with AML who are unfit for or refused intensive chemotherapy; cleaned and validated dataset being finalized and database lock imminent.
DNA damage response program

The Phase 1 combination of sapacitabine and seliciclib is continuing enrollment in an extension study in an enriched population of BRCA positive patients with advanced breast cancer.
Cyclin dependent kinase (CDK) inhibitor program

Continued recruitment in Phase 1, first-in-human trial of CYC065, a CDK2/9 inhibitor, to evaluate safety, tolerability and pharmacokinetics in patients with solid tumors. The sixth dose escalation level has been reached.

Preclinical data presented at the Childhood Cancer Meeting 2016 demonstrated effectiveness of CYC065 against neuroblastoma models with an overexpression and amplification of MYCN, a driver of neuroblastoma.
KEY UPCOMING MILESTONES

SEAMLESS study

Report top-line data and determination of submissibility to regulatory authorities, anticipated late fourth quarter 2016 or early 2017.
Progress the Paediatric Investigation Plan for sapacitabine with the European Medicines Agency.
DNA damage response program

Progress Phase 1 sapacitabine and seliciclib extension cohort in a breast cancer patient population enriched for BRCA mutations.
Initiate Phase 1 part 3, to include BRCA mutation positive, pancreatic and ovarian cancer patients.
CDK Inhibitor Program

Report top-line results of the CYC065 Phase 1 trial in patients with solid tumors.
Report data when available from ongoing investigator sponsored trials (ISTs) evaluating seliciclib in patients with Cushing’s disease and rheumatoid arthritis. Additionally, seliciclib is being evaluated in cystic fibrosis though a license and supply agreement with ManRos Therapeutics.
Sapacitabine in myelodysplastic syndromes (MDS)

Plan Phase 1/2 trial of sapacitabine in combination with other agents to determine safety and tolerability.
Plan a Phase 2 randomized controlled trial (RCT) of sapacitabine in combination with other agents following review of all relevant clinical data with mature follow-up.
THIRD QUARTER 2016 FINANCIAL RESULTS

Cash and cash equivalents totaled $18.0 million as of September 30, 2016 compared to $20.4 million at December 31, 2015. Approximately $5.2 million was raised from the sale of common stock through the Company’s at-the-market facility with FBR Capital Markets. A further $1.5 million was received in October 2016 through this facility, resulting in a proforma cash balance as of September 30, 2016 of $19.5 million. Based on current plans, the Company estimates that it has capital resources to fund operations through the second quarter of 2018.

Revenue for the three months ended September 30, 2016 was $0.2 million, compared to $0.7 million for the same period of the previous year, with the decrease primarily related to grant revenue related to CYC065, for which the grant ended in December 2015.

Research and development expenses were $2.4 million for the three months ended September 30, 2016 and $2.9 million for the three months ended September 30, 2015.

General and administrative expenses were $1.3 million for the three months ended September 30, 2016 and $1.2 million for the three months ended September 30, 2015.

On November 14, 2016 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported its financial results for the quarter ending September 30, 2016, the first quarter of the Company’s 2017 fiscal year (Press release, DelMar Pharmaceuticals, NOV 14, 2016, View Source [SID1234516612]). DelMar executive management will host a business update conference call and live webcast for investors, analysts and other interested parties on Tuesday, November 15, 2016 at 4:30 pm EST.

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"Looking back, 2016 has been a transformational year for our Company," stated Jeffrey Bacha, DelMar’s Chairman and chief executive officer. Our goals this year included listing our company’s shares on a national exchange, successfully completing our initial Phase I/II clinical trial in refractory GBM, preparing for a pivotal Phase III clinical trial and expanding our research efforts with VAL-083 into new indications."

RECENT CORPORATE HIGHLIGHTS

DelMar raised gross proceeds of approximately $7.2 million in a private placement and our common stock began trading on the Nasdaq Capital Markets under the symbol "DMPI";
DelMar confirmed that the Institutional Review Board ("IRB") at the University of Texas MD Anderson Cancer Center ("MD Anderson") approved our planned Phase II clinical study with VAL-083 in patients with GBM at first recurrence/progression;
DelMar reported promising data from our Phase I/II clinical trial of VAL-083 in refractory GBM at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") annual meeting; supporting the potential for an improved survival benefit for bevacizumab-failed GBM patients treated with VAL-083 in comparison to current salvage chemotherapy;
DelMar announced the successful completion of an ‘End of Phase II’ meeting with the FDA and confirmed plans to advance VAL-083 into a pivotal Phase III clinical trial for GBM patients whose tumors have progressed following treatment with bevacizumab;
DelMar entered into a collaborative research agreement with Accurexa, Inc. to explore local delivery of VAL-083 as a potential combination therapy for the treatment of brain tumors;
DelMar continued to report promising research results supporting the potential of VAL-083 in new indications:
Presented data supporting the effectiveness of VAL-083 against chemotherapy-resistant ovarian cancers, including data suggesting the potential for treatment synergy of VAL-083 combined with Astra Zeneca’s PARP inhibitor, Lynparza (olaparib), at the 11th Biennial Ovarian Cancer Research Symposium;
Presented new research results demonstrating that VAL-083 exhibits a distinct mode of action compared to other chemotherapies used in the treatment of newly diagnosed GBM patients at the European Association of Neuro-Oncology annual meeting;
Presented new non-clinical data supporting the differentiation of VAL-083 in the treatment of lung cancer in comparison to platinum and tyrosine kinase inhibitor treatments at the AACR (Free AACR Whitepaper) New Horizons in Cancer Research meeting;
Presented data indicating that VAL-083 offers potential therapeutic alternatives in difficult-to-treat pediatric brain tumors at the AACR (Free AACR Whitepaper) – Advances in Pediatric Research: From Mechanisms and Models to Treatment and Survivorship Conference.
DelMar continued to strengthen its intellectual property portfolio. DelMar now holds six issued US patents and seven issued patents outside of the US representing thirteen patent families in various stages of prosecution, and over 100 patent filings in total.
"We were very pleased with the outcome of our End-of-Phase II meeting and the guidance provided by the FDA," said Mr. Bacha. "The DelMar clinical team and our advisors have been developing a Phase III study protocol that would provide strong statistical power, enroll fewer than 200 patients, and is designed to reach its final endpoint in two years or less. We plan to submit the protocol to the FDA in the coming weeks, and subject to the FDA’s continued guidance and availability of funding, anticipate initiating a registration-directed Phase III study as soon as practicable."

DelMar is also pleased to confirm the accomplishment of critical steps toward initiating new clinical trials designed to position VAL-083 as an alternative to temozolomide in newly diagnosed GBM for patients whose tumors exhibit a high expression of MGMT, the DNA repair enzyme linked to failure of standard front-line chemotherapy and poor patient outcomes:

The MD Anderson IRB has approved the protocol of the Company’s planned Phase II Study of VAL-083 in patients with MGMT-unmethylated, bevacizumab-naive recurrent glioblastoma. DelMar anticipates completing study initiation activities and commencing the dosing of patients in the coming weeks.
The Company is also completing the final remaining steps required for initiation of an international clinical trial in newly diagnosed GBM patients with high expression of MGMT.
"Importantly, these two new Phase II trials are largely supported through our collaborators, so their initiation will not materially impact our near-term cash expenditures," stated Mr. Bacha. "Our current working capital will support DelMar’s operations for at least the next twelve months and, while our planned Phase III clinical trial will require additional financing, we have the opportunity to expand our clinical research efforts in GBM and to continue advancing our research into new indications without an immediate need to raise additional funds."

EXPECTED NEAR-TERM MILESTONES

Commence treating patients at MD Anderson with VAL-083 in a Phase II clinical study of GBM patients with high expression of MGMT at first recurrence/progression;
Submit a Phase III protocol to the FDA proposing a pivotal, multi-center, randomized clinical trial of VAL-083 in GBM patients who have failed both standard chemo-radiation and bevacizumab;
Initiate a Phase II clinical trial in China in newly-diagnosed GBM patients as an alternative to temozolomide in patients with high expression of MGMT;
Expand DelMar’s clinical research with VAL-083 in new solid tumor indications, subject to financial resources;
Present our research results at international peer-reviewed scientific meetings;
Continue to pursue pre-clinical research that further differentiates VAL-083 from established chemotherapeutic regimens, and to identify opportunities for combination therapy;
Maximize the value of the VAL-083 pipeline through collaborations with industry leaders in attractive oncology markets; and
Continue to build our intellectual property portfolio.