Whether directly or indirectly, at some point in life most people have been affected by cancer. Second only to heart disease, cancer is one of the most common causes of death reported in the United States. Without early diagnosis and consistent treatment, the more than 100 types of cancer can quickly prove fatal. Conducting research and collecting clinical data are vital in the fields of diagnosis and treatment, and DelMar Pharmaceuticals, Inc. (DMPI) is one drug development company with a singular focus on cancer treatment.
At the International Symposium on Clinical and Basic Investigation in Glioblastoma (GBM 2015) in Spain, DelMar Pharmaceuticals presented updated clinical data from its Phase I/II study of the effects of the prototype drug, VAL-083, in patients diagnosed with refractory glioblastoma multiforme (GBM).
Clinical data was collected from GBM patients who previously underwent surgical and/or radiation treatment. Furthermore, patients must have failed both Avastin® (bevacizumab) and Temodar® (temozolomide) in order to participate in the Phase I/II study. The purpose of DelMar’s Phase I/II study is to determine a dosing regimen. Data was collected from two sets of sub groups: low dose and high dose patients. Low dose patients received 5 mg/m2 daily x 3 every 21 days, while high dose patients received 30mg/m2 or 40mg/m2 every 21 days.
In the summary presented at GBM 2015, the study showed two particularly promising pieces of data:
● Patients in the low dose sub-group had a median survival of five months, versus a median survival of nine months for patients in the high dose subgroup following initiation of VAL-083 treatment (p = 0.04).
● Increased survival was observed at six, nine and twelve months following initiation of treatment in the high-dose subgroup compared to the low dose sub-group.
"We view the trend toward a meaningful survival benefit, and at doses that were well tolerated by patients, as highly promising for the potential of VAL-083 to offer a new treatment alternative for GBM patients,” said Jeffrey Bacha, DelMar's president and CEO. “Our subsequent and more detailed analysis of data from the Phase I portion of this trial continues to support these observations.”
VAL-083, a drug product of Valent Technologies,has yielded promising results in the areas of cancer treatment research prior to DelMar’s study. VAL-083 proved safe and effective in treating lung, brain, cervical and ovarian cancers in over 40I and II clinical studies sponsored by the US National Cancer Institute. Currently, VAL-083 is approved to treat chronic myelogenous leukemia lung cancer in China.
A Promising Future for DelMar’s Cancer-Fighting Efforts
The next step for DelMar is a 14-patient Phase II expansion cohort. During this phase, data will be collected regarding the safety and effectiveness of administering 40mg/m2 before moving on to Phase II/III. If the data proves the dose is safe for patients, the dose may increase to 45mg/m2 in Phase II/III. "We are pleased with the momentum of our enrollment in the trial. We look forward to presenting further data from the Phase II expansion study as we continue activities geared toward the initiation of a registration-directed Phase II/III clinical trial over the course of the next several months," said Bacha.
GBM is a malignant adult brain tumor that can affect vision and motor skills, as well as impair cognitive functions. The prognosis for those afflicted with GBM is dismal, with a current median survival rate of four to six months, and less than five percent survival rate in the fifth year. Through continued researchand raised awareness, companies like DelMar will continue to strive toward more effective cancer treatment, and a brighter future for cancer patients.
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