NEW YORK--()--MabCure Inc. (OTCBB:MBCI)
We are pleased to provide this update on recent important developments and on our progress in several key areas, including our ovarian cancer program, our prostate cancer program, recent financing, and the joining of our new chief scientist.
We have made significant strides with our ovarian cancer program, transitioning from the research phase into the development phase. This is manifested in two key areas: (a) nearing conclusion of our clinical studies in Bangkok, Thailand on diagnosing ovarian cancer and, (b) the scale up manufacturing of highly purified “reagent grade” antibodies which will be used to analyze the specimens obtained from our clinical studies.
Our major focus has been to advance our monoclonal antibodies (MAbs) for the diagnosis of ovarian cancer. We are pleased to report that our confirmatory study, announced in July of last year, was accepted for presentation at the upcoming Annual Meeting of the Society of Gynecological Oncology (SGO) to be held in Orlando, Florida in March 2011. The study, in collaboration with Professor Vergote, Chairman of the Department of Gynecological Oncology at Leuven University Hospital in Belgium, one of the largest and most respected medical institutions in Europe, has shown that our MAbs were able to correctly detect ovarian cancer in blood serum with 94% sensitivity and 100% specificity (i.e., no false positives). This high degree of specificity is of particular clinical importance since it could provide a simple and reliable tool for distinguishing between women having life threatening ovarian cancer and women having benign tumors of the ovaries.
As a follow up study, we have expanded our collaboration with Professor Vergote, and are planning to analyze a larger number of blood samples of patients with ovarian cancer and benign disease. These specimens are currently stored at the Leuven University Hospital biobank.
Our ovarian cancer clinical study at the Ramathibodi Hospital in Bangkok, Thailand, in collaboration with the Thai National Cancer Institute, began in January of last year and has nearly completed enrollment of the required number of patients. The study is aimed at evaluating our antibody-based test for diagnosing ovarian cancer in the blood and urine of patients presenting with pelvic mass and differentiating such growth from benign tumors of the ovaries. Clinical specimens obtained from both the Belgian and Thai studies are expected to be analyzed concurrently with our reagent-grade purified MAbs during the second quarter of this year.
In addition to our primary focus on the diagnosis of early stage ovarian cancer, we are developing a prostate cancer diagnosis program. Diagnosing early stage prostate cancer and differentiating it from benign disease (i.e., benign prostatic hyperplasia, or BPH) has proven to be a major challenge since serum levels of the PSA, the marker used routinely for the diagnosis of the disease, are associated with very high rates of false positives and false negatives. In addition, there are no reliable methods for determining if a diagnosed prostate cancer is aggressive and life threatening or indolent. Our aim is to tackle both of these issues and provide clinicians with a simple blood or urine diagnostic test.
Using MabCure’s proprietary process, we have created more than 30,000 MAbs against prostate cancer cells, ten of which appear to recognize tumor-specific antigens (TSA) that are unique to prostate cancer. We are planning a clinical study in Belgium to select those MAbs that can detect prostate cancer in urine and blood with high specificity and sensitivity, and differentiate cancerous growth from benign growth.
We are very fortunate to have Dr. Charles Tackney join MabCure as its new Chief Scientific Officer. Dr. Tackney brings with him invaluable pragmatic experience in developing in vitro diagnostics from his long tenure at Ortho Clinical Diagnostics (OCD), a Johnson & Johnson company, most lately, as Director of OCD’s In Vitro Diagnostics Biomarker Evaluation Group. As planned, Dr. Tackney is leading our research and development with the goal of achieving in vitro diagnostic tests that meet industry standards, as well as FDA regulatory guidelines.
On the financial front, we recently secured a $10 million equity funding facility which will ensure that MabCure is adequately capitalized for funding our planned clinical trials, for meeting the needs of our ongoing research and development activities, and for working capital. The funding facility will be used gradually as required and is exercisable at our discretion, which allows for financial flexibility to ensure the funding of our capital needs going forward.
Lastly, we are pleased to inform you that our Board of Directors has approved our plan to relocate MabCure’s lab facilities and executive offices to New York City, within a network of world class biomedical research centers, which we believe will enhance MabCure’s position in the field, present new collaboration opportunities and accelerate R&D. We anticipate that the relocation will be completed during the second quarter of this year, and will not interfere with our ability to achieve our clinical milestones in a timely manner.
About MabCure Inc.
MabCure is a biotechnology company whose vision is to change the perception of cancer as being a largely incurable disease. MabCure owns proprietary technology for the creation of unique and highly specific monoclonal antibodies (MAbs), which we plan to develop as diagnostic tools, imaging agents, and drugs to treat lethal cancers. MabCure’s initial goal is to develop its novel MAbs as diagnostic tools for the detection of ovarian and prostate cancers at an early stage, when these diseases are still localized and highly curable. For further information visit the Company’s website at www.mabcure.com.
This news release contains “forward-looking statements”. Statements in this news release which are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the change of business focus of the management of the Company and the inability of the Company to pursue its current objectives. These forward-looking statements are made as of the date of this news release and the Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements.