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Interim Phase I/II Clinical Trial Data for VAL-083 Show Clinical Activity in Refractory Glioblastoma

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Key Points

  • VAL-083 is a bifunctional DNA alkylator that crosses the blood-brain barrier with preferential accumulation in brain tumor tissue.
  • Interim data from a phase I/II clinical study evaluating VAL-083 show stable disease or tumor regression and improved disease symptoms in 25% of evaluated patients with recurrent glioblastoma multiforme.
  • Enrollment in the first four cohorts of the VAL-083 trial has been completed with no significant adverse events or dose-limiting toxicity observed.

Interim phase I/II clinical trial data for VAL-083—a bifunctional DNA alkylator that crosses the blood-brain barrier with preferential accumulation in brain tumor tissue—in patients with recurrent glioblastoma multiforme were presented by Shih et al at the 4th Quadrennial Meeting of the World Federation of Neuro-Oncology, held in conjunction with the 18th Annual Meeting of the Society for Neuro-Oncology on November 21 to 24 in San Francisco.

Glioblastoma Multiforme

Median survival for patients with recurrent glioblastoma multiforme is about 6 months. According to the National Cancer Institute, in 2010, more than 22,000 Americans were estimated to have been diagnosed with glioblastoma multiforme and 13,140 were estimated to have died from brain and other nervous system cancers. Glioblastoma accounts for about 15% of all brain tumors and occurs in adults between the ages of 45 and 70 years old.

“The fact that we are seeing evidence of clinical activity against refractory glioblastoma multiforme at this stage is very promising,” Jeffrey Bacha, President & CEO of DelMar Pharmaceuticals, said in a statement. “VAL-083 is safe and well-tolerated by patients at the doses tested to date, and based on historical data, we anticipate seeing stronger patient benefit and tumor responses as we achieve higher doses.”

Study Details

The VAL-083 phase I/II study is an open-label, single-arm dose-escalation trial that is designed to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of the drug in patients with recurrent glioblastoma multiforme. Eligible patients enrolled in the study were those who had previously been treated for glioblastoma multiforme with surgery and/or radiation and in whom bevacizumab (Avastin) and temozolmide had failed (unless contraindicated).

According to the presentation, enrollment in the first four cohorts of the VAL-083 trial has been completed with no significant adverse events or dose-limiting toxicity observed. In addition, 25% of patients evaluated in cohorts 1 to 3 exhibited stable disease or tumor regression and improved disease symptoms. Evaluation and clinical observation of cohort 4 is ongoing.

VAL-083 has been studied in over 40 phase I and phase II clinical studies by the National Cancer Institute, and has shown safety and efficacy in treating several cancers, including leukemia, lung, brain, cervical, and ovarian tumors.

The study was sponsored by DelMar Pharmaceuticals.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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