On June 15, 2015 DelMar Pharmaceuticals reported that it has been invited to present at The World NSCLC Summit being held June 23-24, 2015 in Boston, MA (Press release, DelMar Pharmaceuticals, JUN 15, 2015, View Source [SID:1234505427]).
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Jeffrey A. Bacha, president & CEO of DelMar Pharmaceuticals, will present a scientific talk regarding the anti-cancer mechanism of VAL-083 (dianhydrogalactitol) as a potential treatment of non-small cell lung cancer ("NSCLC") and the Company’s plans for expanding its clinical research with VAL-083 into human clinical trials for NSCLC.
VAL-083 is a "first-in-class" bi-functional alkylating agent mediating inter-strand DNA crosslinks at N7 of guanine. VAL-083 has previously demonstrated activity against lung cancer in preclinical and clinical trials and is approved for the treatment of lung cancer in China. DelMar is currently conducting a Phase I/II clinical trial with VAL-083 as a potential treatment for glioblastoma multiforme, the most common and deadly form of brain cancer.
The Company recently presented an abstract at the annual meeting of the American Association of Cancer Research ("AACR") entitled, "In vitro activity of dianhydrogalactitol alone or with platinum drugs in the treatment of NSCLC."
The activity of VAL-083 against solid tumors, including lung cancer, has been established in both pre-clinical and human clinical trials conducted by the NCI. VAL-083 has been approved by the Chinese Food and Drug Administration ("CFDA") for the treatment of lung cancer. However, sales of VAL-083 in China have been limited by a lack of modern data, poor distribution, and preference for targeted therapies such as tyrosine kinase inhibitors ("TKIs") in the modern era.
DelMar’s data demonstrate that VAL-083’s mechanism is distinct from platinum-based chemotherapy, the current standard of care for NSCLC and that VAL-083 retains its high level of anti-cancer activity in p53 mutated NSCLC cell lines, which are highly resistant to platinum based therapy. DelMar’s data also suggest that the combination of VAL-083 with either cisplatin or oxaliplatin provides a super-additive (synergistic) effect against NSCLC cell lines, including those resistant to TKI therapy in vitro.
DelMar believes these new data suggest the potential of VAL-083 to be used in combination with platinum-based chemotherapy and to address modern unmet medical needs in the treatment of TKI-resistant NSCLC, especially where platinum-based therapy has already failed or is predicted to give sub-optimal outcomes. In addition, VAL-083 readily crosses the blood brain barrier suggesting that it may be possible for VAL-083 to treat patients whose lung cancer has spread to the brain.
As a next step, DelMar plans to initiate a clinical trial in NSCLC in collaboration with Guangxi Wuzhou Pharmaceutical Group Co. Ltd. (Guangxi Wuzhou Pharma). Under the terms of the Company’s collaboration agreement with Guangxi Wuzhou Pharma, DelMar is responsible for establishing protocols and conducting clinical trials, and Guangxi Wuzhou Pharma is responsible for the costs associated with clinical trials conducted in China. DelMar’s goal is to work with Guangxi Wuzhou Pharma to develop new clinical data to help support product growth of VAL-083 in China and to establish clinical proof of concept to expand globally its independent drug development efforts with VAL-083 as a potential treatment for NSCLC.
About The World NSCLC Summit
The World NSCLC Summit will bring together over 100 senior level attendees from the pharmaceutical industry to discuss the challenges in the development of new therapies for the treatment of NSCLC. Over the two days the World NSCLC Summit feature presentations on the latest updates from the NSCLC pipelines of small and large drug developers, and feature discussions around all the latest trends in personalized medicine, as pertaining to this disease area, through case studies from early discovery to commercial development.
For more information, visit View Source
About NSCLC
Lung cancer is a leading cause of cancer-related mortality around the world and effective treatment for lung cancer remains a significant global unmet need despite advances in therapy. In general, prognosis for lung cancer patients remains poor, with 5-year relative survival less than 14% among males and less than 18% among females in most countries. Globally, the market for lung cancer treatment may exceed $7 billion by 2019 according to a report published by Transparency Market research.
Non-small cell lung cancer ("NSCLC") is the most common type of lung cancer. There are three common forms of NSCLC: adenocarcinomas are often found in an outer area of the lung; squamous cell carcinomas are usually found in the center of the lung next to an air tube (bronchus); and large cell carcinomas, which can occur in any part of the lung and tend to grow and spread faster than adenocarcinoma. NSCLC accounts for 85% of all lung cancer cases in the United States and approximately 90% of lung cancer cases diagnosed in China.
The current standard of care for newly diagnosed NSCLC is platinum-based combination therapy or TKI therapy for patients whose cancer exhibits epidermal growth factor receptor ("EGFR") mutations. Patients exhibiting EGFR mutations have shown an initial response rate to TKIs which exceeds the response rate for conventional chemotherapy. However, TKI resistance has emerged as an important unmet medical need.
About VAL-083
VAL-083 is a "first-in-class", small-molecule chemotherapeutic. In more than 40 Phase 1 and 2 clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated safety and efficacy in treating a number of cancers including lung, brain, cervical, ovarian tumors and leukemia. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia and lung cancer and has received orphan drug designation in Europe and the U.S. for the treatment of gliomas.
DelMar is currently studying VAL-083 in a multi-center Phase I/II clinical trial for patients with refractory glioblastoma multiforme (GBM) in accordance with the protocol that has been filed with the U.S. Food and Drug Administration ("FDA"). (ClinicalTrials.gov Identifier NCT01478178). As a potential treatment for glioblastoma, VAL-083’s mechanism of action appears to be unaffected by the expression of MGMT, a DNA repair enzyme that causes chemotherapy resistance to front-line treatment with Temodar (temozolomide).