The FDA Grants Fast Track Status to DelMar Pharmaceuticals’ Product VAL-083

This Fast Track status applies to two ongoing clinical trials sponsored by DelMar Pharmaceuticals to evaluate VAL-083 as a potential treatment for rGBM.  These trials include:

– A Phase 2 study in bevacizumab-naïve MGMT-unmethylated GBM patients conducted in collaboration with The University of Texas MD Anderson Cancer Center; and,

– A Phase 3 study of patients whose disease has progressed following prior treatment with temozolomide and bevacizumab (the STAR-3 trial).

Fast track designation is designed to expedite the review of drugs that show promise in treating life-threatening diseases and address unmet medical needs, with the goal of getting new treatments to patients earlier. Fast Track designation provides sponsors with an opportunity for increased frequency of communication with FDA to ensure an optimal development plan and to collect appropriate data needed to support drug approval.

Outside of rGBM, DelMar has initiated a Phase 2 clinical trial of VAL-083 in newly-diagnosed MGMT-unmethylated GBM. DelMar also recently received notice of allowance from the FDA of an IND for a Phase 1/2 trial of VAL-083 in patients with recurrent platinum-resistant ovarian cancer.

The Drug

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. According to Delmar, VAL-083 has demonstrated clinical activity against 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. 

For studies’ details click

Orphan Designation: VAL-083 has been granted FDA orphan drug designation for the treatment of glioma, medulloblastoma and ovarian cancer, and in Europe for the treatment of malignant gliomas.

More Studies 

– VAL-083 is also in Phase 3 clinical trial for recurrent GBM following treatment with temozolomide and bevacizumab.

– VAL-083 is being studied in two collaborator-supported, biomarker-driven, Phase 2 clinical trials for MGMT-unmethylated GBM.

DelMar also recently announced the allowance of a separate IND for VAL-083 as a potential treatment for platinum-resistant ovarian cancer.

Prohost November Observations

On November 22, 2017, we posted in Today’s Highlights at an article titled “Could DelMar Pharmaceuticals’ (DMPI) drug VAL-083 ($1 Stock Price) Defeat Glioblastoma?”

In the article we wrote that DelMar might have surprised the financial community reporting that 93% of patients with Glioblastoma multiforme (GBM) were alive and 40% of patients enrolled achieved stable disease following treatment with VAL-083 used as a single agent.

The promising early observations about VAL-083 as a potential new treatment option are supported by extensive preclinical research into VAL-083’s unique mechanism of action. Based on these recent data, the firm believes that 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.

Read the past article that was posted under Today’s Highlights on November 22, 2017

Prohost Observations and Reminders

In the article posted in November 22, Prohost wrote: “Surprising is the fact that DelMar’s product VAL-083 as described above and as the results demonstrated has yet to attract the attention of the investment community. Until the announcement of the posters’ presentation 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, the stock was trading at $0.98 with a market cap of around $21 million only. Now, even following the promising news, the stock has gained around $0.06 after adding 17% to its price in premarket trading.”

The comforting part about the results is that the trial was conducted at the famous world renowned MD Anderson Cancer Center in Houston Texas.

Mr. Saiid Zarrabian, DelMar’s Interim Chief Executive Officer stated, it is too early to interpret overall survival (OS) results from this study, but the substantial disease control observed to date in the treatment recurrent GBM, which can double in size within 6-8 weeks, is a positive observation at this stage.

In November article, we recognized the fact that in case future results would come positive regarding overall survival (OS), it might be too late to buy the stock at a reasonable price. This observation might be the result of considering that the number of eyes that will be following on this firm and its stock will surely be numerous…

 What Happened Since November 22, however, is that the stock went further down to below $1 instead of flying.

 Following today’s news, though, the stock gained around 60% in early trading. To remind you about today’s news we reiterate that the FDA has granted Fast Track designation for the company’s drug VAL-083, in recurrent glioblastoma (rGBM).

This is good news for the drug that is also showing promise on ovarian cancer and in combination treatments on other solid tumors.

Do Not miss the upcoming Prohost Letter “The Year in Review”.

Prohost Forward-Looking: Material presented here is for informational purposes only. Nothing in this article should be taken as a solicitation to purchase or sell securities. Before buying or selling any stock you should do your own research and reach your own conclusion. Further, these are our ‘opinions’ and we may be wrong. We may have positions in securities mentioned in this article. You should take this into consideration before acting on any advice given in this article. If this makes you uncomfortable, then do not listen to our thoughts and opinions. The contents of this article do not take into consideration your individual investment objectives. Also, investing in stocks includes certain risks. Our advice is that you should consult with your own financial adviser before making an investment.

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