Last Updated on November 21, 2019 by Sultan Beardsley
In my last article I summarized my discussions with DelMar Pharmaceuticals’ (Nasdaq: DMPI) President and CEO Saiid Zarrabian and the value proposition DelMar offers investors. To recap, DelMar is a clinical stage pharmaceutical company focused on developing new therapies for cancer patients with limited to no treatment options. DelMar’s lead clinical asset VAL-083 is a “first-in-class” chemotherapeutic with a unique mechanism of action. Initially, VAL-083 is being investigated as a treatment for patients with Glioblastoma Multiforme (GBM), an extremely aggressive and resilient type of cancer. In particular, the focus is on patients of the highest unmet need. These patients are identifiable with a well-established biomarker (MGMT-unmethylated) and for whom the current standard of care (SOC) (Temozolomide + Radiation) lacks a significant survival benefit.
At the ASCO conference in June 2019 DelMar presented promising phase 2 data. An updated version announced in August 2019 provided additional data points further supporting the robust efficacy initially observed. Of 17 evaluable patient 9 had complete responses (CR, 53%), 7 had partial responses (PR, 41%), and 1 had progressive disease (PD, 6%). Importantly, 16 of the 20 patients (80%) enrolled in the study at that time were still alive. This last piece is crucial given the study is designed to assess if first-line treatment with VAL-083 in combination with radiation therapy can improve survival rates over Temozolomide (TMZ). The endpoints in the study are thus progression-free survival (PFS), PFS at six-months, and overall survival (OS) at the study’s completion (projected for the 4th quarter of calendar 2020). Based on historical data the benchmark to beat for PFS is 6.9 months. Now notice that only 17 of 20 patients were evaluable in August. As the company pointed out in the press release, two of the patients had not been in the study long enough and one sadly died. This is expected in a clinical study recruiting up to 30-patients. What does this mean? It adds color to our picture of the type of data we may see this Friday, November 22nd when DelMar presents two posters with the latest phase 2 data at the 2019 Society for Neuro-Oncology Annual Meeting (SNO).
In Friday’s posters I imagine we’ll see response rates of patients in both the newly diagnosed and recurrent cohorts. This data will likely include even more data points consisting of the two patients who joined the study this fall. Given that six months has passed since the first-line treatment data was first presented as ASCO it’ll be interesting to see how many patients are still alive. We can use this info to extrapolate what the survival benefit is shaping up to be. Moreover, the data flow does not stop at SNO. Mr. Zarrabian has told me that he plans to update the investment and medical communities on the study’s progress in all three settings (Newly Diagnosed, Recurrent, and Adjuvant) throughout 2020 at various conference, including at AACR April 24-29, 2020, and ASCO on May 29-June 3, 2020. The Company is also planning on providing top line data results for its ongoing phase 2 trials, including 1st line, and recurrent setting studies for MGMT-unmethylated patients in the fourth quarter of calendar 2020.
You may have noticed that the Company recently filed registration documents with the SEC. These documents relate to the registration of warrants previously issued by the Company. They do not relate to any planned financings by DelMar. As previously disclosed by the Company, it has enough capital to achieve the milestones noted above. Finally, be sure to listen to the Key Opinion Leader (KOL) panel discussion on DelMar’s s GBM clinical trial this Friday from 4:15-5:30 PM MT during SNO. A recording of the event will uploaded shortly after on the company website. Good luck to my fellow longs ahead of this pivotal moment for DelMar Pharmaceuticals and potentially the current GBM treatment paradigm.
I am/we are long DMPI