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Del Mar Pharmaceuticals to Present Interim Clinical Data on VAL-083 in Refractory Glioblastoma at Society for Neuro-Oncology (SNO) Annual Meeting


11/15/2012 8:39:06 AM

VANCOUVER, British Columbia, Nov. 15, 2012 /PRNewswire/ -- Del Mar Pharmaceuticals (BC) Ltd. ("DelMar Pharma") today announced that the Company will present two scientific posters at the Society for Neuro-Oncology (SNO) 17th Annual Scientific Meeting, which is being held in Washington, DCNovember 15-18, 2012. 

On Friday November 16th, DelMar will present a poster entitled, "VAL-083, Novel N7 Alkylating Agent, Surpasses Temozolomide Activity and Inhibits Cancer Stem Cells Providing a New Potential Treatment Option for Glioblastoma Multiforme".

On Saturday November 17th, DelMar will present a poster entitled, "Phase I/II Study of VAL-083 in Patients with Recurrent Malignant Glioma".

Jeffrey Bacha, President & CEO of DelMar Pharma stated, "We are pleased to present these data at the annual SNO meeting.  We believe our interim clinical data along with new non-clinical data being presented serve to differentiate VAL-083 from standard of care and demonstrate the drug's potential as a future treatment option for patients suffering from glioblastoma multiforme who have failed both front-line therapy with temozolomide (Temodar®) and have failed or are ineligible for second-line bevacizumab (Avastin®)."

Mr. Bacha noted that the data that will be presented from the first two cohorts in the Company's dose-escalating Phase I/II study support that VAL-083 is safe and well tolerated. An overall response rate of 28.5%, where tumor growth had stabilized or regressed, has been observed at doses investigated to date.

"While these data with VAL-083 are interim in nature, we are enthusiastic about the results to date.  We look forward to continuing to work with our clinical investigators toward determining an optimal dosing regimen for future registration trials and to the potential opportunity of offering patients a valuable new treatment option," added Mr. Bacha.

About VAL-083
VAL-083 represents a 'first in class' small-molecule chemotherapeutic. VAL-083 has been assessed in multiple NCI-sponsored clinical studies in various cancers including lung, brain, cervical, ovarian tumors and leukemia.  Published pre-clinical and clinical data suggest that VAL-083 may be active against a range of tumor types.  VAL-083 is approved as a cancer chemotherapeutic in China for the treatment of chronic myelogenous leukemia and lung cancer

Based on published research, the mechanism of action of VAL-083 is understood to be a bi-functional alkylating agent; however, the functional groups associated with alkylating events has been shown to differ from other alkylating agents used in the treatment of GBM.

VAL-083 has previously demonstrated activity in cyclophosphamide, BCNU and phenylanine mustard resistant cell lines and no evidence of cross-resistance has been encountered in published clinical studies.  Based on the presumed alkylating functionality of VAL-083, published literature suggests that DNA repair mechanisms associated with Temodar and nitrosourea resistance, such as 06-methylguanine methyltransferace (MGMT), may not confer resistance to VAL-083. 

VAL-083 readily crosses the blood brain barrier where it maintains a long half-life in comparison to the plasma.  Published preclinical and clinical research demonstrates that VAL-083 is selective for brain tumor tissue.

VAL-083 has been assessed in multiple studies as chemotherapy in the treatment of newly diagnosed and recurrent brain tumors.  In general, tumor regression was achieved following therapy in greater than 40% of patients treated and stabilization was achieved in an additional 20% - 30%.  In published clinical studies, VAL-083 has previously been shown to have a statistically significant impact on median survival in high grade gliomas when combined with radiation vs. radiation alone. 

The main dose-limiting toxicity related to the administration of VAL-083 in previous clinical studies was myelosuppression.  No significant hepatic, renal or pulmonary toxicity has been reported in the literature or overseas commercial experience. 

About Glioblastoma Multiforme (GBM)
Glioblastoma multiforme (GBM) is the most common and most malignant form of brain cancer. Of the estimated 17,000 primary brain tumors diagnosed in the United States each year, approximately 60% are gliomas. Attention was drawn to this form of brain cancer when Senator Ted Kennedy was diagnosed with glioblastoma and ultimately died from it.

Newly diagnosed patients suffering from GBM are initially treated through invasive brain surgery, although disease progression following surgical resection is nearly 100%. Temozolomide (Temodar) in combination with radiation is the front-line therapy for GBM following surgery. Temodar currently generates more than US$950 million annually in global revenues primarily from the treatment of brain cancer.

Approximately 60% of GBM patients treated with Temodar® experience tumor progression within one year. Bevacizumab (Avastin®) has been approved for the treatment of GBM in patients failing Temodar®. According to the Avastin® label, approximately 20% of patients failing Temodar respond to Avastin therapy.   Analysts anticipate annual Avastin® revenues for the treatment of brain cancer may reach US$650 million by 2016.

Approximately 48% of patients who are diagnosed with GBM will fail both front-line therapy and Avastin. DelMar Pharma estimates that the market for treating GBM patients the post-Avastin failure exceeds US$200 million annually in North America.

About the VAL-083 Clinical Study
The Phase I/II study is an open-label, single arm dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of VAL-083 in patients with histologically confirmed initial diagnosis of primary WHO Grade IV malignant glioma (GBM), now recurrent.  Patients with prior low-grade glioma or anaplastic glioma are eligible, if histologic assessment demonstrates transformation to GBM.  Patients with secondary brain tumors due to CNS metastases are also eligible for the study.

GBM patients must have been previously treated for GBM with surgery and/or radiation, if appropriate, and must have failed both Bevacizumab (Avastin®) and temozolomide (Temodar®), unless either or both are contra-indicated. 

Response to therapy and disease progression will be evaluated by MRI prior to each treatment cycle.  An initial phase of the study will involve dose escalation cohorts until a maximum tolerated dose (MTD) is established in the context of modern care.  Once the modernized dosing regimen has been established, additional patients will be enrolled at the MTD (or other selected optimum dosing regimen).

DelMar Pharma is conducting the study under the direction of Dr. Howard Burris at the Sarah Cannon Research Institute in Nashville, Tennessee with a second center in Sarasota, Florida. 

Please refer to clinicaltrials.gov identifier NCT01478178 for further details on this clinical trial.

About DelMar Pharma
Del Mar Pharmaceuticals was founded in 2010 to develop and commercialize proven cancer therapies in new orphan drug indications where patients are failing modern targeted or biologic treatments. The Company's lead asset, VAL-083, is currently undergoing clinical trials in the United States as a potential treatment for refractory glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer.  VAL-083 benefits from extensive clinical research sponsored by the US National Cancer Institute, and is currently approved for the treatment of chronic myelogenous leukemia (CML) and lung cancer in China. Published pre-clinical and clinical data suggest that VAL-083 may be active against a range of tumor types via a novel mechanism of action.

For further information, please visit www.delmarpharma.com
or contact Jeffrey A. Bacha, President & CEO  (604) 629-5989

SOURCE Del Mar Pharmaceuticals


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