$DMPI Positive Interim Results from VAL-083 Study in MGMT-unmethylated Recurrent GBM
40% of recurrent GBM patients treated to date achieved stable disease as measured by magnetic resonance imaging (MRI)
VANCOUVER, British Columbia and MENLO PARK, Calif., Nov. 21, 2017 — DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) (“DelMar” or the “Company”), a biopharmaceutical company focused on the development of new cancer therapies, today provided an overview of three scientific posters presented at the 22nd Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO) held on November 16-19, 2017 in San Francisco, CA.
DelMar reported that 96% of patients enrolled were alive at the time of the analysis and 40% of patients enrolled were reported to have achieved stable disease as assessed by MRI following treatment with VAL-083 as a single agent. “While it is too early to interpret overall survival results from this study, the substantial disease control observed to date in the treatment recurrent GBM, an aggressive tumor that can double in size within 6-8 weeks, is an important and positive observation at this stage,” said Mr. Saiid Zarrabian, DelMar’s Interim Chief Executive Officer.
“The promising early observations from our ongoing Phase 2 clinical trial of VAL-083 as a potential new treatment option for MGMT-unmethylated GBM are also supported by extensive preclinical research into VAL-083’s unique mechanism of action,” added Mr. Zarrabian. “Based on these recent data, we believe VAL-083 represents a potential solution for some of the most important unmet medical needs in the treatment of GBM and other central nervous system tumors.”
DelMar provided an update on the company’s ongoing Phase 2 clinical studies in a poster entitled “Clinical Trials with dianhydrogalactitol (VAL-083) in MGMT-unmethylated Glioblastoma,” which is being conducted in collaboration with The University of Texas MD Anderson Cancer Center. This trial is designed to enroll up to 48 patients to determine if VAL-083 treatment improves overall survival compared to historical reference control.
- DelMar reported that 27 subjects have been screened and 15 have been enrolled since the opening of recruitment in February 2017. To date, the trial has enrolled at a rate ahead of initial projections.
- All patients enrolled in the study have recurrent MGMT-unmethylated GBM with radiographic evidence of progression and were not surgically resected at the time of enrollment.
- DelMar reported that 96% of patients enrolled were alive at the time of the analysis and 40% of patients enrolled were reported to have achieved stable disease following treatment with VAL-083 as a single agent, as assessed by MRI.
- Enrollment is ongoing and median survival has not yet been reached in the trial.
- In general, VAL-083 treatment was well tolerated by patients with observed side effects (myelosuppression) similar to prior clinical experience.
The Company also provided an overview of the design a separate Phase 2 clinical trial of VAL-083 for newly diagnosed MGMT-unmethylated GBM patients on this poster. In this trial, which was recently initiated at Sun Yat-Sen University Cancer Center, patients will be treated with VAL-083 plus radiotherapy as an alternative to standard-of-care temozolomide plus radiation in the front-line setting. The trial is designed to enroll up to 30 patients with MGMT-unmethylated GBM to determine if VAL-083 treatment improves progression free survival (PFS) compared to a historical reference control. This trial is being supported though DelMar’s collaboration with Guangxi Wuzhou Pharmaceutical (Group) Co., Ltd.
In addition, DelMar also presented two additional pre-clinical posters during the conference:
- The Distinct Cytotoxic Mechanism of Dianhydrogalactitol (VAL-083) Overcomes Chemoresistance and Provides New Opportunities for Combination Therapy in the Treatment of Glioblastoma.
VAL-083 induces potent anti-cancer activity against treatment-resistant cells from glioblastoma, lung, prostate and ovarian tumors through a distinct mechanism of action. Cancer cells treated with VAL-083 exhibit persistent DNA double-strand breaks and activation of the homologous DNA repair (HR) system. Activation of the HR system is an indicator of VAL-083’s unique anti-tumor activity.
When combined with topoisomerase or PARP inhibitors, the treatment effect of VAL-083 is increased in a synergistic or super-additive manner. Taken together, these data support the broad potential of VAL-083 as a new treatment against a wide range of cancers both as a single agent and in combination with other established cancer therapies.
- Dianhydrogalactitol (VAL-083) Overcomes Chemoresistance in Pediatric Malignant Brain Tumors and Displays Synergy with Topoisomerase Inhibitors
Pediatric high-grade glioma (HGG) and medulloblastoma are aggressive childhood brain tumors with a high incidence of recurrence and very few patients achieve long-term survival. VAL-083 demostrates potent activity as a single agent against both chemo-resistant pediatric HGG and medulloblastoma independent of p53 status. DelMar also reported that VAL-083 potentiates radiotherapy and exhibits synergy when used in combination with topoisomerase inhibitors, two regimens commonly used in the treatment of childhood brain tumors.
“We continue to be highly enthusiastic about the potential of VAL-083 as a novel treatment for cancer patients who have limited or no treatment options,” added Mr. Zarrabian. “The excellent work performed by our world class academic research collaborators and our in-house team presented at the SNO meeting showcases VAL-083’s potential both as a single agent and as a component of combination therapeutic regimens.”
DelMar’s poster presentations can be viewed in their entirety on DelMar’s website at http://www.delmarpharma.com/scientific-publications.html
About VAL-083
VAL-083 (dianhydrogalactitol) is a “first-in-class”, DNA-targeting agent that introduces interstrand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM and ovarian cancer in historical clinical trials sponsored by the U.S. National Cancer Institute (NCI). DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by common mechanisms of chemoresistance in vitro. Further details regarding these studies can be found at http://www.delmarpharma.com/scientific-publications.html.
VAL-083 has been granted an orphan drug designation by the U.S. FDA Office of Orphan Products for the treatment of glioma, medulloblastoma and ovarian cancer, and in Europe for the treatment of malignant gliomas.
About DelMar Pharmaceuticals, Inc.
DelMar Pharmaceuticals is focused on the development and commercialization of new therapies for cancer patients who have limited or no treatment options. By focusing on understanding tumor biology and mechanisms of treatment resistance, the Company identifies biomarkers to personalize new therapies in indications where patients are failing, or have become resistant to modern targeted or biologic treatments.
The Company’s current pipeline is based around VAL-083, a “first-in-class,” small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers including central nervous system, ovarian and other solid tumors (e.g. NSCLC, bladder cancer, head & neck) in clinical trials sponsored by the NCI. Based on DelMar’s internal research programs and these prior NCI-sponsored clinical studies, the Company is conducting clinical trials to support the development and commercialization of VAL-083 across multiple oncology indications to solve significant unmet medical needs.
VAL-083 is also being studied in two collaborator-supported, biomarker driven, Phase 2 clinical trials for MGMT-unmethylated GBM. Overcoming MGMT-mediated resistance represents a significant unmet medical need in the treatment of GBM. DelMar also recently announced the allowance of a separate IND for VAL-083 as a potential treatment for platinum-resistant ovarian cancer.
Further information on DelMar’s clinical trials can be found on clinicaltrials.gov: https://www.clinicaltrials.gov/ct2/results?cond=&term=val-083&cntry1=&state1=&recrs
For further information, please visit http://delmarpharma.com/; or contact DelMar Pharmaceuticals Investor Relations: ir@delmarpharma.com / (604) 629-5989.
Connect with the Company on Twitter, LinkedIn, Facebook, and Google+.
Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company’s products and technology; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in our filings with the SEC, including, our current reports on Form 8-K.
TraderPower Featured Companies
Top Small Cap Market News
- $SOBR InvestorNewsBreaks – SOBR Safe Inc. (NASDAQ: SOBR) Closes on $8.2M Private Placement
- $CLNN InvestorNewsBreaks – Clene Inc. (NASDAQ: CLNN) Announces Participation at Two Upcoming Investor Conferences
- $ATBHF Aston Bay Holdings Ltd. (TSX.V: BAY) (OTCQB: ATBHF) Releases Updated Report on Storm Copper Project Drilling Program
- $LGVN InvestorNewsBreaks – Longeveron Inc. (NASDAQ: LGVN) to Present at This Month’s Congenital Heart Surgeons’ Society Annual Meeting
- $LEXX InvestorNewsBreaks – Lexaria Bioscience Corp. (NASDAQ: LEXX) Begins Subject Dosing in Human Pilot Study #3 Evaluating Oral DehydraTECH-Processed Tirzepatide
- $FSTTF InvestorNewsBreaks – First Tellurium Corp. (CSE: FTEL) (OTC: FSTTF) Shares Additional Information on the PyroDelta Thermoelectric Generator, Relationship with Subsidiary
- $TMET.V Gold Stutters as Strong US Jobs Data Dampens Expectations of Large Rate Cuts
- $RFLXF JPMorgan Executive Says US Backlash Against ESG Is Exaggerated
- $SFWJ InvestorNewsBreaks – Software Effective Solutions Corp. (d/b/a MedCana) (SFWJ) Releases Report on Series of Acquisitions, Multiple Cannabis Licenses
- $EAWD IEA Hosts G20 Ministers, Influential Personalities to Discuss Clean and Affordable Energy Transition
Recent Posts
- $EAWD IEA Hosts G20 Ministers, Influential Personalities to Discuss Clean and Affordable Energy Transition
- $SFWJ InvestorNewsBreaks – Software Effective Solutions Corp. (d/b/a MedCana) (SFWJ) Releases Report on Series of Acquisitions, Multiple Cannabis Licenses
- $RFLXF JPMorgan Executive Says US Backlash Against ESG Is Exaggerated
- $TMET.V Gold Stutters as Strong US Jobs Data Dampens Expectations of Large Rate Cuts
- $FSTTF InvestorNewsBreaks – First Tellurium Corp. (CSE: FTEL) (OTC: FSTTF) Shares Additional Information on the PyroDelta Thermoelectric Generator, Relationship with Subsidiary
- $LEXX InvestorNewsBreaks – Lexaria Bioscience Corp. (NASDAQ: LEXX) Begins Subject Dosing in Human Pilot Study #3 Evaluating Oral DehydraTECH-Processed Tirzepatide
- $LGVN InvestorNewsBreaks – Longeveron Inc. (NASDAQ: LGVN) to Present at This Month’s Congenital Heart Surgeons’ Society Annual Meeting
- $ATBHF Aston Bay Holdings Ltd. (TSX.V: BAY) (OTCQB: ATBHF) Releases Updated Report on Storm Copper Project Drilling Program
Recent Comments
Archives
- October 2024
- January 2023
- June 2022
- December 2021
- September 2021
- August 2021
- July 2021
- June 2021
- May 2021
- April 2021
- March 2021
- February 2021
- January 2021
- December 2020
- November 2020
- October 2020
- September 2020
- August 2020
- July 2020
- June 2020
- May 2020
- April 2020
- March 2020
- February 2020
- January 2020
- December 2019
- November 2019
- October 2019
- September 2019
- August 2019
- July 2019
- June 2019
- May 2019
- April 2019
- March 2019
- February 2019
- January 2019
- December 2018
- November 2018
- October 2018
- September 2018
- August 2018
- July 2018
- June 2018
- May 2018
- April 2018
- March 2018
- February 2018
- January 2018
- December 2017
- November 2017
- October 2017
- September 2017
- August 2017
- July 2017
- June 2017
- May 2017
- April 2017
- March 2017
- February 2017
- January 2017
- December 2016
- November 2016
- October 2016
- September 2016
- August 2016
- July 2016
- June 2016
- May 2016
- April 2016
- March 2016
- February 2016
- January 2016
- December 2015
- November 2015
- October 2015
- September 2015
- August 2015
- July 2015
- June 2015
- May 2015
- April 2015
- March 2015
- February 2015
- January 2015
- December 2014
- November 2014
- October 2014
- September 2014
- August 2014
- July 2014
- June 2014
- May 2014
- April 2014
- March 2014
- February 2014
- January 2014
- December 2013
- November 2013
- October 2013
- September 2013
- August 2013
- July 2013
- June 2013
- May 2013
- April 2013
- March 2013
- February 2013
- January 2013
- December 2012
- November 2012
- October 2012
- September 2012
- August 2012
- July 2012
- June 2012
- May 2012
- April 2012
- March 2012
- February 2012
- January 2012
- December 2011
- November 2011
- October 2011
- September 2011
- August 2011
- July 2011
- June 2011
- May 2011
- April 2011
- March 2011
- February 2011
- January 2011
- December 2010
- November 2010
- October 2010
- September 2010
- August 2010
- July 2010
- June 2010
- May 2010
- April 2010
- March 2010
- February 2010
- January 2010
- December 2009
- November 2009
- October 2009
- September 2009
- August 2009
- July 2009
- June 2009