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ASCO15 EXCLUSIVE: Experimental Brain Cancer Drugs Heads to Phase II/III Trial This Year: DelMar Pharmaceuticals CEO



6/2/2015 8:04:17 AM

ASCO15 EXCLUSIVE: Experimental Brain Cancer Drugs Heads to Phase II/III Trial This Year: CEO
June 2, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor

The chief executive of DelMar Pharmaceuticals told BioSpace (DHX) Tuesday that the that data the company presented at the American Society of Clinical Oncology (ASCO)’s this week is a promising therapy for patients with a brutal form of brain cancer that may not be able to undergo resection and chemotherapy.

Jeffrey A. Bacha, president and CEO of DelMar Pharmaceuticals, Inc, told BioSpace the data for experimental drug VAL-083 was particularly exciting because of the effect it has on extending survival time for animals with glioblastoma multiforme (GBM), a type of brain cancer.

“The overall survival of nine months demonstrated at the higher doses in our clinical trial for GBM patients that have failed both temozolomide (TMZ) and Avastin is clinically meaningful for these patients who have no available therapy and a very poor prognosis,” Bacha told BioSpace.

The data demonstrated that VAL-083 may be effective against GBM, boosting median survival time for animals treated with 4 mg/kg VAL-083 to 72 days compared to 48 days for controls (p<0.0001). Median survival time for 3 mg/kg VAL-083 was 54 days.

In the second in vivo model (BT74) reported yesterday, the additional data showed that VAL-083 treatment increased survival time in animals bearing intracranial BT74 tumors compared to untreated control. BT74 tumors are traditionally resistant to TMZ.
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“VAL-083 is an alkylating agent whose cytotoxic anti-cancer mechanism is believed to be via the formation of DNA crosslinks at N7 position of guanine. Because these N7 adducts appear not to be subject to MGMT-mediated repair, VAL-83 may be an effective chemotherapeutic in the treatment of TMZ-resistant GBM,” said the company in a statement.

“VAL-083 has been demonstrated to cross the blood brain barrier and accumulate in brain tumor tissue. Previous studies show that TMZ activity is similar in cancer stem cells (CSC) and their paired non-CSC from primary GBM tissues independent of their MGMT expression.”

Bacha said patients with poor prognoses would likely benefit the most from the data, including those unable to undergo the standard existing treatment, which is surgical resection followed by TMZ and radiation therapy.

“Clinicians who reviewed our data at ASCO were encouraged by the potential of VAL-083 in this population,” he said, adding the company will soon be rolling the drug into late-stage trials later this year.

“We also were pleased to confirm that we have initiated a 14 patient Phase II expansion cohort, which we expect to report on later this year as we advance VAL-083 toward a registration-directed Phase II/III in refractory GBM,” said Bacha. “We are targeting to initiate the Phase II/III trial in the second half of 2015.”



Will PfizerKline Become the Next Pharma Player?
The speculation surrounding a possible bid from Pfizer Inc. (PFE) for struggling GlaxoSmithKline (GSK) is heating up, after one closely-watched biotech analyst said in a note last week that Pfizer buying the company would “unlock access to its balance sheet and improve its tax situation.”

Gregg Gilbert, a biotech analyst at Deutsche Bank, wrote in a note to investors “Introducing PfizerKline” that he thinks a deal would be “materially accretive” for both companies. Gilbert estimated that a bid priced at $29.86 a share, via half stock and half cash, which would push up Pfizer’s earnings per share by 10 percent to 16 percent beginning in 2016.

“We believe that the company has a sense of urgency to create value by leveraging the power of its balance sheet to do needle-moving deals,” Gilbert wrote. “Since media reports in the past have pointed to the potential for a Pfizer/GSK combination, we are revisiting that theme.”

We want to know, dear readers, if you agree? Should Glaxo continue going it alone, or might Pfizer buy it and create one of the world’s largest pharma players in history?


Read at BioSpace.com


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