In an April 19, 2018 research note, analyst Ram Selvaraju with H.C. Wainwright & Co. reported that DelMar Pharmaceuticals Inc. (DMPI:NASDAQ) announced positive updates with respect to two ongoing clinical trials of VAL-083, which were presented via posters at the recent American Association for Cancer Research meeting. VAL-083 is the company's chemotherapeutic being developed as a treatment for various cancers, including glioblastoma multiforme (GBM).
The first update concerns the Phase 2 study of VAL-083 in 48 patients with MGMT-unmethylated, bevacizumab (Avastin)-naÔve, recurrent GBM to determine if treatment with VAL-083 improves overall survival from that in historical reference. This trial is a collaboration with the University of Texas MD Anderson Cancer Center. Of the total 48 patients, 7 more have been enrolled since Oct. 31, 2017, taking the number now to 22. Seven, or 32%, of those 22 patients have demonstrated stable disease as a best response.
Median overall survival in this patient population is seven months, Selvaraju noted, adding that a study result of a ten plus-month median overall survival would "have clearly demonstrated therapeutic effect." Such data are expected later this year and "may provide the transformational catalyst investors are seeking."
The second update is in regard to the Phase 1/2 trial, in which 24 weeks of VAL-083 are being delivered in combination with radiotherapy in up to 30 patients with newly diagnosed MGMT-unmethylated GBM. This study, being undertaken with the Sun Yat-sen University Cancer Center, has two parts, the first of which is dose confirmation, which is in progress.
For this component, intravenous doses of VAL-083 are to be escalated from 20 to 30 to 40 milligrams per meter squared per day (20 to 30 to 40 mg/m2/day) "to assess safety and activity when administered concurrently with radiation therapy (XRT) to confirm the maximum tolerated dose," explained Selvaraju. To date, treatment with the 20 and 30 mg/m2/day doses has been completed.
To date, no dose-limiting toxicities have been identified post multiple treatments with VAL-083, Selvaraju indicated. In the Phase 2 study being conducted with MD Anderson, myelosuppression has been the most commonly reported adverse effect. "We believe these findings underscore the relatively low toxicity burden associated with DelMar's compound and bode well for further clinical development of the molecule," he wrote.
The second component of the Phase 1/2 trial is an expansion, in which an additional 20 patients will be given 40 mg/m2/day of VAL-083 concurrently with XRT.
Selvaraju reiterated H.C. Wainwright's Buy rating and $12 per share price target on DelMar Pharmaceuticals, whose stock is currently trading at around $0.91 per share.
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Disclosures from H.C. Wainwright & Co., DelMar Pharmaceuticals Ltd., April 19, 2018
Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.
I, Raghuram Selvaraju, Ph.D., certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.
None of the research analysts or the research analystís household has a financial interest in the securities of DelMar Pharmaceuticals Inc. (including, without limitation, any option, right, warrant, future, long or short position).
As of March 31, 2018 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of DelMar Pharmaceuticals Inc.
Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.
The Firm or its affiliates did receive compensation from DelMar Pharmaceuticals Inc. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.
H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for DelMar Pharmaceuticals, Inc. during the past 12 months.
The Firm does not make a market in DelMar Pharmaceuticals Inc. as of the date of this research report.