DelMar Pharmaceuticals, Inc. (OTCQB: DMPI) ("DelMar") today announced the completion of a $10.5 million private placement.
Charles Vista, LLC acted as the company's placement agent in the unit offering. Each unit consists of one share of common stock and one common stock purchase warrant. The maximum offering in the Private Placement consisted of 9,375,000 units for gross proceeds of $7.5 million. In addition, the placement agent has been granted an over-allotment option. The overallotment option was increased to 3,750,000 Units for additional gross proceeds of $3.0 million to accommodate investor interest. The overallotment option has been exercised in full in conjunction with this closing.
"We are very pleased with the strong interest in our private placement. These funds will position us to accelerate the advancement of our ongoing VAL-083 clinical trials for refractory glioblastoma, the most common and aggressive form of brain cancer," stated DelMar Pharma President & CEO Jeffrey Bacha .
Mr. Bacha stated, "We are very excited to announce the engagement of Booke and Company. We are very impressed with their years of experience and successful results in advising companies in all industries. Their strong creditability and wealth of contacts within the investment community will complement our ongoing relationship with LifeSci Advisors, LLC and leverage our success as a public company. We look to a long and productive relationship."
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(R) experience tumor progression within one year. Bevacizumab (Avastin(R)) has been approved for the treatment of GBM in patients failing Temodar(R). According to the Avastin(R) label, approximately 20% of patients failing Temodar respond to Avastin therapy. Analysts anticipate annual Avastin(R) 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(R)) and temozolomide (Temodar(R)), 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 inNashville, Tennessee with a second center in Sarasota, Florida. In November 2012, DelMar presented interim data from the clinical trial at the Society for NeuroOncology Annual Meeting demonstrating that VAL-083 is well tolerated and that some patients having failed prior therapy showed stable disease or tumor regression at doses tested to date. DelMar is continuing to evaluate VAL-083 to determine an optimal dose for Phase II and registration studies of VAL-083 in patients with GBM.
Please refer to clinicaltrials.gov identifier NCT01478178 for further details on this clinical trial.
About DelMar Pharma
DelMar 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.
About Booke and Company, Inc.
Booke and Company, Inc., a leading independent financial investor relations consulting firm, develops and maintains investor interest for public company clients. Through the years, it has developed a disciplined, dedicated approach to building long-term shareholder value in a professional and well- managed investor relations process. The company's comprehensive financial investor relations programs focuses on maximizing visibility within the investment community for client companies that cover the range from large-cap, mid-cap, small-cap to micro-cap companies in both the domestic and international arenas.
Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company's ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company's products and technology; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in our filings with the SEC, including, our current reports on Form 8-K. We do not undertake to update these forward-looking statements made by us.
SOURCE DelMar Pharmaceuticals, Inc.