About

About DelMar Pharmaceuticals

DelMar Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of new cancer therapies. Our lead product candidate, VAL-083, is a first-in-class small molecule chemotherapy that is currently being evaluated in a Phase 2 clinical trial for the treatment of refractory glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. We are also exploring VAL-083 as a therapy for front-line GBM and solid tumors including non-small cell lung cancer (NSCLC) and ovarian cancer.

We have acquired certain exclusive commercial rights in China where VAL-083 is approved as a chemotherapy for the treatment of chronic myelogenous leukemia (CML) and lung cancer.

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About the Clinical Trials

VAL-083 is a structurally unique, "first-in- class", small-molecule chemotherapeutic. Based on historical data and our own research, we believe that VAL-083 has the potential to offer physicians and patients a new paradigm in the treatment of Glioblastoma Multiforme (GBM).

The purpose of this phase 2, single arm, biomarker-driven study is to determine if treatment of O-6-methylguanine-DNA methyltransferase (MGMT) unmethylated recurrent glioblastoma with VAL-083 improves overall survival (OS), compared to historical control.

For Patients With MGMT Unmethylated, Bevacizumab-naive Recurrent Glioblastoma: More Information

This is an adaptive design, randomized controlled, Phase 3 clinical trial in patients with glioblastoma multiforme (GBM) or gliosarcoma (GS), previously treated with surgery (if appropriate), standard of care chemo-radiation with temozolomide, +/- adjuvant temozolomide, and bevacizumab and now has progressive disease during or after bevacizumab.

For Patients With Recurrent Glioblastoma Who Have Failed Standard Temozolomide/Radiation Therapy and Bevacizumab (STAR-3): More Information

The purpose of this Phase 2, open-label, single-arm study is to determine the safety and the maximal tolerated dose (MTD) of VAL-083 in combination with a standard of care radiation regimen when used to treat newly diagnosed GBM in patients with unmethylated promoter of the methylguanine-DNA methyltransferase (uMGMT) gene. Pharmacokinetic (PK) properties will be explored and tumor responses to treatment will be evaluated.

For Patients With Newly Diagnosed GBM Having Unmethylated MGMT Expression: More Information

This is an open label, multi-center, Phase 1/2 clinical trial in subjects with recurrent adenocarcinoma of the ovary who have been previously treated with a minimum of two courses of platinum-based chemotherapy, and up to two additional cytotoxic regimens that may also have included platinum (no more than four total lines of prior therapy), with or without bevacizumab, whose cancer has recurred within six months of the most recent platinum-based chemotherapy. All eligible subjects will receive VAL 083 i.v. in a once weekly cycle until disease progression, development of other unacceptable toxicity, death, withdrawal of consent, loss to follow-up, or Sponsor ending the study, whichever occurs first.

A Multi-center Study of VAL-083 in Patients With Recurrent Platinum Resistant Ovarian Cancer (REPROVe): More Information

The purpose of this Phase 1/2, open-label, single-arm study is to determine the safety and the maximal tolerated dose (MTD) of VAL-083 in patients with recurrent malignant glioma. Pharmacokinetic (PK) properties will be explored and tumor responses to treatment will be evaluated.

For Patients With Recurrent Malignant Glioma: More Information

The safety and efficacy of the investigational use of this product has not been determined. There is no guarantee that the investigational use listed will be filed with and/or approved for marketing by a regulatory agency.