Bristol-Myers Squibb Co. (NYSE: BMY) introduced Taxol to the market in January of 1993 after over 30 years of development in partnership with the National Cancer Institute (NCI). While the chemotherapy became one of the best-selling drugs of all time, the exclusive rights to the NCI’s research meant that countless other drug programs never reached commercialization. Many of these programs showed promising signs of efficacy in certain patient populations.
DelMar Pharmaceuticals Inc. (OTCQB: DMPI) acquired VAL-083 from Valent Technologies LLC – a company owned by Chief Science Officer Dr. Dennis Brown. The first-in-class small molecular chemotherapeutic drug is based a compound that has undergone 40 Phase I and II clinical trials sponsored by the NCI as a treatment against various forms of cancer. Published pre-clinical and clinical data suggest that it may be active against a range of different tumor types.
Promising Data in GBM Patients
DelMar Pharmaceuticals’ initial target is glioblastoma multiforme (GBM), which is the most common and lethal form of brain cancer. Currently, patients must undergo surgery to remove as much of the tumor as possible followed by radiotherapy and chemotherapy. But, nearly all patients diagnosed with the disease relapse following first-line treatment and the 1-year survival rate is just 25%. Worse, the 5-year survival rate drops to just 3%.
VAL-083 induces DNA cross-links in cancerous cells that leads to apoptosis – or programmed cell death. Currently, the company is studying VAL-083 in a multi-center Phase I/II clinical trial for patients with refractory GBM in accordance with the protocol that has been filed with the FDA. In the Phase I portion of the trial, the drug demonstrated a dose-dependent improvement after only one or two cycles of treatment. These preliminary data indicated that patients receiving the drug in higher doses had a median survival of 9.0 months compared to 4.4 months at lower doses. Notably, the drug also works on patients that have high expression of the enzyme MGMT and gene p53 mutations that render conventional therapies ineffective.
The drug has also been granted orphan drug status in the U.S. and E.U., which could significantly accelerate the development timeline. Management anticipates that the Phase II portion of the study will generate top-line survival data in the first half of this year and advance to Phase III trials by the end of 2016.
Compelling Value Proposition
There are no shortage of pharmaceutical companies developing small molecule drugs that fight cancer, including ArQule Inc.’s (NASDAQ: ARQL) ARQ-197, GTx Inc.’s (NASDAQ: GTXI) GTx-024, or Oncothyreon Inc.’s (NASDAQ: ONTY) ONT-380, which all take different approaches targeting different forms of cancer. But, DelMar Pharmaceuticals’ unique approach to drug development is compelling for a number of different reasons from an investor standpoint.
First, VAL-083 has a lot of historical evidence of clinical activity from over 40 NCI-sponsored clinical trials along with others conducted outside of the United States. Second, the company will incur less cost since it’s able to leverage these prior studies in building its current studies and pushing the drug through commercialization. And finally, the prior data and orphan drug designation could help reduce the time to market by a significant amount.
VAL-083 has potential beyond GBM indications as well. Management believes that the drug could be effective against a wide range of different cancers, including lung cancer, ovarian cancer, cervical cancer, and other solid tumor cancer types. These indications represent multi-billion dollar markets around the world, while existing data from NCI studies and its own GBM research could accelerate commercialization into these markets.
DelMar Pharmaceuticals has found opportunity in abandoned drugs from the NCI’s arrangement with Bristol-Myers Squibb in the past. Its VAL-083 therapeutic has the potential to address a broad range of solid tumor cancer types, while an orphan drug designation and prior research could equate to a faster pathway to commercialization for investors.
For more information, visit the company’s website at www.delmarpharma.com.