August 19, 2013 Issue
The Most Powerful Name In Corporate News and Information
Having discovered the Pathway that Enables Individual Tumor Cells to Enter into Small Blood Vessels, MetaStat is developing their MetaSite Breast™and MenaCalc™ Products for Accurately Predicting the Probability of Cancer Metastasizing
MetaStat's proprietary platform technologies are the result of more than 15 years of collaboration involving four scientific/academic institutions, which enabled the Company to characterize the behavior, mechanics, and genetics of metastatic cancer cells.
The Company’s MetaSite Breast™ and MenaCalc™ diagnostic product lines are designed to accurately predict the probability of cancer metastasizing. They are intended to allow clinicians to better "customize" cancer treatment decisions by positively identifying and differentiating high-risk patients who need aggressive therapy and by sparing low-risk patients from the harmful side effects and expense of chemotherapy and radiation therapies. Furthermore, the Company believes the MenaCalc™ diagnostic platform may be applicable in up to 80% of all solid epithelial cancers, including breast, prostate, lung and colorectal, which account for over 50% of all new cancer cases in the U.S. each year. As such, the Company believes its diagnostic products represent a significant breakthrough for cancer patients and their doctors because 90% of all solid tumor cancer deaths are due from metastasis.
Additionally, the Company
believes its MenaBloc™ chemotherapy technology will target and interrupt key
pathways essential for the development of systemic metastasis in multiple
epithelial derived tumors.
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – August 19, 2013
Dr. Bronsther: I have been involved as an informal analyst in the biotech arena for the better part of twenty years. My career prior to taking on this role with MetaStat was as an academic surgeon. I was Professor of Surgery most recently at George Washington University School of Medicine. I saw the science underlying MetaStat about two to three years ago, when potential investors asked me to do their diligence. I thought this was the most remarkable advance in cancer biology that I had seen in decades, and I asked for an opportunity to get involved with this company. Initially, I was Chairman of the Board and then around Christmas of last year they asked me to step up and become the CEO of MetaStat.
CEOCFO: Would you explain the science to us please?
Dr. Bronsther: We have licensed this science from two outstanding and renowned institutions that are on the forefront of cancer research. Our two principle scientists, who are also on our scientific board, are John S. Condeelis, Ph.D., who is Professor and Chairman of the Department of Anatomy and Structural Biology at the Albert Einstein College of Medicine and Frank B. Gertler, Ph.D., who is a Professor at the Institute for Cancer Research at MIT.
The fundamental discovery is the actual mechanism by which individual cancer cells break off from most solid tumors and acquire the ability to enter into the bloodstream. Only once these individual cancer cells have entered the bloodstream is there the possibility of these patients developing metastatic disease. It is very important to understand when we are dealing with breast cancer, but with other solid cancers as well, that 85% to 90% of all the cancer related deaths do not come from the primary tumor. The most common cause of death from cancers is the metastatic disease that can arise. That means the breast cancer has spread for instance to the liver, lung, brain, or bone.
We are the first company to understand what really enables individual cells to separate from the primary tumor and metastasize. Our scientists have discovered the pathway that enables individual tumor cells to enter into the small blood vessels surrounding the primary tumor, which creates the potential for metastatic disease. Again, this complication of cancer is the most common cause of death for cancer patients.
We think understanding how primary tumors metastasize is what makes the science underlying our company truly remarkable. We believe it is our responsibility to develop strategies to exploit this discovery in clinically applicable ways.
CEOCFO: How are you doing that?
Dr. Bronsther: Our first two near-term opportunities are in cancer diagnostics. The first cancer we are focusing on is breast cancer, but this is a platform discovery. The pathway of metastasis, which I just discussed, is the pathway by which 80% of all solid tumors metastasize. What makes these 80% of tumors common is that they are all of epithelial origin, so they are of a specific cell-type origin. The five largest epithelial cancers are breast, where we have done most of our work, prostate, lung, colon, and rectal cancer. This pathway is broadly applicable to all of these cancers.
The first diagnostic program we are working is called MetaSite Breast™, which is only applicable to women with certain types of breast cancer. Our second diagnostic program is called MenaCalc™ and differs in substantial ways from our first diagnostic program. Specifically, MenaCalc™ is potentially applicable to all patients with epithelial in origin cancer.
We have multiple publications detailing our ability to predict the risk of individual patients developing metastatic disease employing both our MetaSite Breast™ and MenaCalc™ diagnostic assays. We also have preliminary data that is unpublished for MenaCalc™. This unpublished data shows that we are prognostic for individual patients' risk of developing metastatic cancer not just with breast cancer but also with prostate and lung cancer. We are excited about the potential of what these diagnostics offer.
The question we are attempting to answer for patients and their physicians is whether they should or should not be treated with chemotherapy at the time of the original diagnosis of their cancer. That means that a woman with breast cancer is evaluated with scans and blood tests and there is no evidence at the time of presentation of her cancer that the cancer has metastasized. Nonetheless, the vast majority of women still receive chemotherapy as part of the initial treatment of their breast cancer. It turns out that even if left untreated only 35% to 40% of all breast cancers will ever metastasize. If left untreated, they will continue to grow in the breast and potentially into the chest wall, but only a minority of these tumors will ever develop the biological potential to metastasize by entering the bloodstream and spreading to foreign sites. Unfortunately, at present almost 85% of women with newly diagnosed breast cancer are treated with chemotherapy. The reality is only a fraction of these patients can actually benefit from chemotherapy because only a fraction of these tumors have the biological potential to spread through the bloodstream. We have to understand that a complete course of chemotherapy is extremely expensive and more importantly takes at least 6 months and is associated with significant morbidity and a small mortality.
Therefore, the role of
breast cancer diagnostics is to identify the minority of patients whose
tumors have the capability or potential of spreading through the bloodstream
in order to identify those patients who can benefit from chemotherapy.
Similarly, we have the ability to identify those patients whose tumors are
unlikely to metastasize and can therefore spare those patients the
complications of chemotherapy.
CEOCFO: If the majority of women get chemotherapy, how do you know with enough quantity of data that only 30% or 35% of the ones that do not will actually metastasize?
Dr. Bronsther: We had a great amount of historical data on breast cancer before the chemotherapeutic regimen existed, so we really do know the natural history of untreated breast cancer.
CEOCFO: What are your challenges in getting the medical community to pay attention and then women deciding to go ahead with chemotherapy anyway?
Dr. Bronsther: The value of breast cancer diagnostics has already been accepted by the medical community. Guideline makers-the NCCN and ASCO-already recommend that women with newly diagnosed breast cancer have these sorts of tests as part of their initial evaluation before receiving chemotherapy. The problem is that the breast cancer diagnostics now available are imperfect. Through a combination of our MetaSite BreastTM diagnostics and our MenaCalc BreastTM diagnostics, we are going to be able to provide more accurate and actionable information to a much larger percentage of the women with newly diagnosed breast cancer. This will enable patients and their physicians to make more informed decisions, and this informed decision-making is really at the heart of personalized cancer treatment.
CEOCFO: Where are you in the process of development and commercialization?
Dr. Bronsther: We completed our first MetaSite Breast confirmatory trial on just over 500 women. It was built upon multiple preliminary publications. We are now waiting to hear when this will be accepted for publication, and we anticipate that it will be very soon. We have applied for additional cohorts of women with previously diagnosed breast cancer, because we anticipate doing a second and a third trial in the next six to twelve months. Interestingly, because of the platform nature of our technology, these trials can be run in parallel and take less than six months and less than $750,000 each to perform. We believe with these three trials we will have enough data to impact the mindset of the oncologic community, the breast cancer advocacy groups, and more importantly the individual patients. With three strong trials, we believe that we will be well positioned to start marketing the MetaSite Breast diagnostic.
The limitations of the MetaSite Breast diagnostic are identical to the limitations of all of the other breast cancer diagnostics that are in the market. We are only predictive for about 60% of the women with newly diagnosed breast cancer. Those are women who are estrogen receptor positive HER2/neu negative breast cancer. That is the largest subgroup of women with breast cancer. However, our second diagnostic, MenaCalc, that will be commercially available about 12 months after our Metasite Breast assay, can provide prognostic information for 100% of women with newly diagnosed breast cancer. MetaSite and MenaCalc diagnostics will be initially focused on breast cancer, but we anticipate rapid and further development of MenaCalc for prostate and lung cancer.
CEOCFO: What is the key to the commercialization process and what have you learned that will guide you as you are bringing it to market to get the attention that you deserve?
Dr. Bronsther: The first thing we have to achieve is outstanding data. We are well on our way to accomplishing that. With outstanding data, we will be able to influence the oncologists, so that they know who we are and the power of the information we can provide to their patients.
The second group that we have to influence is the insurers and that is actually a more complicated process. We have worked closely with our consultants and we have spoken to the pharmacy or medical director of insurance companies that cover a hundred million lives in America in order to understand the kind of information that will be required in order to assure third-party reimbursement.
The third and maybe most important group that we will have to influence are the breast cancer advocacy groups. Women rely heavily on these types of organizations to get up-to-date information, and we are going to have to have extraordinary data to influence these breast cancer advocacy groups. Through these groups, we can reach individual patients as well.
If you ask me where I am focusing right now, it is on achieving outstanding data. With this data, we hope to influence the oncologic community, achieve third-party reimbursements (with some other requirements), and create a well-coordinated public relations campaign to get access to and influence the breast cancer advocacy groups. If we are successful in influencing all three of these institutions or organizations, our commercial launch will be successful. We have strategies in place to be successful in all of those arenas.
CEOCFO: Why should the business and investment community pay attention to MetaStat?
Dr. Bronsther: We are the only cancer diagnostic company that has licensed the biology through which individual cancers metastasize. All of the other diagnostic companies have what they call a gene signature, which is just an algorithm they have developed. We have licensed the biology by which cancer metastasizes.
Our scientists have discovered a family of proteins at the heart of the metastatic cascade, and we are exploiting this discovery as we develop both our diagnostic and therapeutic platforms. These proteins are virtually non-existent in healthy human beings and offer us the opportunity to develop novel chemotherapeutic agents. We anticipate developing drugs that are potentially capable of preventing or treating metastatic disease. There is no other company out there that is involved in the cancer diagnostic arena that has this therapeutic potential. There is no other company that has this unique protein target.
We think we are tremendously undervalued. We have a market cap right now of about $43 to $44 million. In contrast to our competitors, we believe that our cancer diagnostic platform will allow us to provide more accurate diagnostic information to virtually all women with newly diagnosed breast cancer. Additionally, it has the potential to provide prognostic information to patients with newly diagnosed prostate and lung cancer.
We have extraordinary
scientists. We have an extraordinary management team in place that has over
twenty years of experience in commercializing diagnostics and developing and
marketing therapeutics. Our management expertise is as extraordinary as our
scientific expertise. We are well positioned to have revenue in the next
eighteen months. We have strategies in place to influence all the key
stakeholders. The cancer diagnostic market is almost a $4 billion-dollar
market in America, and the therapeutic market is dramatically larger than
this. I think we can quickly contend for a large percentage of the
diagnostic market because our platform technology allows us to compete for
the breast cancer diagnostic dollar as well as potentially for the
diagnostic dollars for prostate and lung cancer. We are an exciting company
with extraordinary people that has the potential to generate enormous
returns on the investment dollar to new and present shareholders.
“I think we can quickly contend for a large percentage of the diagnostic market because our platform technology allows us to compete for the breast cancer diagnostic dollar as well as potentially for the diagnostic dollars for prostate and lung cancer. We are an exciting company with extraordinary people that has the potential to generate enormous returns on the investment dollar to new and present shareholders.”- Oscar Bronsther
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