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Molecular Biometrics' CEO Discusses Plans To Develop Neurodegenerative Diagnostics

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Jim Posillico
CEO
Molecular Biometrics
Name: James Posillico, PhD
 
Position: President and CEO, Molecular Biometrics
 
Background: Chief Scientific Officer, Cooper Surgical; Founder and Manager, SAGE Biopharma; Senior Vice President of Medical Affairs for International Business Operations, Ares-Serono; Assistant Professor, Harvard Medical School, Departments of Medicine and Biochemistry.
 
Education: PhD in endocrinology, Duke University Medical Center; post-doctoral training, Harvard Medical School.
 

 
Molecular Biometrics is a fairly young private company that recently licensed five broad patents from McGill University relating to metabolomics and biospectroscopy of biomarkers used in molecular diagnostics and personalized medicine.
 
Incorporated in the spring of 2005, the company announced in December that it is expediting the development of its lead product, ViaTest-E, a test for embryo selection for in vitro fertilization. Molecular Biometrics is currently in discussions with the US Food and Drug Administration regarding a pivotal clinical trial for the test.
 
Although Molecular Biometrics’ technology focus has largely been in IVF and maternal fetal health, its proprietary platform has also been validated in neurodegenerative diseases such as Alzheimer’s and Parkinson’s.
 
The Chester, NJ-based company to date has raised $1.8 million in private-equity funding and is in discussions with venture capital firms and corporate entities in the pharmaceutical industry for more financial backing.
 
CEO James Posillico discussed with Pharmacogenomics Reporter the company’s current projects and future plans to expand into the neurodegenerative diagnostics space.
 
Could you discuss your lead product candidate and the stage of development it’s in?
 
Our first product candidate for a variety of reasons is focused on the IVF area. I’ve been a reproductive endocrinologist, and I’ve been in this field of infertility and reproductive health for about 22 to 23 years. One of the longstanding problems in IVF after one spends a lot of time and money in trying to becoming pregnant is selecting the embryo for transfer back to the woman. There is no viable way of doing that today that’s primarily done by looking at the embryo under a microscope and trying to judge viability. What our technology has done is look at the distribution of this population of biomarkers [related to] metabolism and through a series of studies in about 1,500 patients [we have] been able to develop metabolomic profiles of biomarkers in embryos that produce the pregnancy versus embryos that fail to produce the pregnancy during IVF. These studies were done in collaboration with investigators in the US, several in Europe, and a very large program in Japan. So we’ve had a great deal of work done with our lead product in IVF. We’ve been to the FDA and we have one more meeting planned with the FDA this fall to launch our pivotal trial.
 
How many employees do you currently have and do you have any positions you are trying to fill?
 
Right now we have eight full-time employees … All of our people are practitioners are in the field of IVF. We are actually recruiting additional people for the company. Our core expertise that we’re recruiting for are people who have spectroscopy backgrounds in the near infrared spectroscopy and Ramen spectroscopy areas, as well as people with very strong pseudometric or bioinformatics backgrounds. A lot of what we do is identify the biomarkers using our spectral analyses, but then we have to mine this data that is generated and use fairly sophisticated … algorithms to do these comparisons.
 
Could you discuss the technology the company is developing?
 
Our technology is a true platform. We are really looking at the same population of biomarkers that are very much present during oxidated metabolism. These biomarkers are noted in our intellectual property, as are the different methodologies of spectral analyses for targeting these biomarkers. What we do, for example, is [use] primarily near infrared spectroscopy as well as Raman spectroscopy. In looking at the neurodegenerative diseases, our sample is the human plasma. So it’s a very simple sample to acquire. The biomarker distribution between patients with Alzheimer’s disease and patients with Parkinson’s disease in each batch control is very different. So we get a fingerprint or a profile of these biomarkers through spectral analyses and then through the confirmed diagnosis of the patient, correlate the … profile to the state of the disease. We are actually pursuing additional studies in the Parkinson’s disease area through grant support from the [Small Business Innovation Research] process and through some private foundations.
 
Could you discuss any studies you’ve conducted to validate the IVF product?
 
In IVF, unfortunately, there haven’t been a lot of well-powered clinical trials. In our study, we had over 320 patients. The study was important because we used what is known as a single embryo transfer protocol and in that scenario, in the IVF transfer process, only one embryo was selectively transferred back to the patient. So there’s no ambiguity whatsoever to the establishment of our test and its ability to identify a viable embryo that produced a pregnancy, compared to the non-viable embryos that failed to produce a pregnancy. So it’s a very simple one-embryo transfer to the mother. She got pregnant or she didn’t get pregnant. And we were able to show very definitive data and physical correlation between our test predicting that metabolomic profile versus embryos that weren’t very healthy embryos and could not produce a pregnancy. This is a milestone in the field because the only useful tool that physicians and scientists have for assessing embryo quality in IVF is to look at [embryos] subjectively under a microscope. There are not biological assays or other biological tests that are available to ascertain embryo quality. So there is a tremendous amount of anticipation around this type of technology to help physicians and embryologists identify the number of embryos that are viable and to reduce the number of embryos that can be transferred to limit the number of multiple births that are otherwise commonplace in IVF.
 
Could you discuss the results of the pilot study to identify diagnostic biomarkers for idiopathic Parkinson’s disease, which Molecular Biometrics presented at the American Academy of Neurology’s 59th Annual Meeting in May?
 
The first study presented at the American Academy of Neurology, which was also been submitted for publication, is a study in a pilot group of 340 patients with age-match controls. It was a comparison between the distribution of these biomarkers of oxidated metabolism in the Parkinson’s patients versus the Alzheimer’s patients, in the age-match control. As a pilot study, its given us the groundwork to establish a prospective study, which we are organizing next.
 
We are going to be involved in the NIH Procept study. It’s an ongoing longitudinal study that was originated with the Parkinson’s group out of NIH and we’ve been invited to use our technology to look at the 500 plus patients that are being followed in that study. That in itself is a very concise and tight population of people for us to have access to to further validate the test in the patients that we believe are confirmed Parkinson’s disease patients.
 
In addition to that we have two major grants to look at the subdivision of patients in different types of Parkinson’s disease to see if the distribution of these biomarkers is different in different types of disease states in Parkinson’s. And these would be studies that we would expect to engage starting in October to November of this year. 
 
Why did the company decide to enter the neurodegenerative diagnostics space, and could you characterize the competition in this space?
 
The neurodegenerative space is obviously very attractive for us because it’s a huge market and with an obviously large unmet need there. We sort of focused our attention on Parkinson’s disease, as opposed to Alzheimer’s or other areas, because there are no known functional biomarkers in Parkinson’s disease. We do know there are two functional biomarkers presently at play in pathology in Alzheimer’s, but those reside in the spinal fluid. So that of course means that these patients have to have lumbar punctures in order to be diagnosed. Our test only requires a finger prick or a blood draw to get a small 7-microliiter volume of plasma to analyze.
 
We felt we had a lot more control and ability to have some identity in the work we’re doing in the Parkinson’s area, simply because the number of players is less. The actual number of people looking for interventions and diagnostics in the filed of neurodegenerative diseases is very large. … We do know that the number of players who are using spectroscopy-based analyses or testing to look at markers of oxidated metabolism is nil. To our knowledge we’re the only ones using that biomarker population as a target for a diagnostic. So we feel that there is quite a good opportunity here to develop our technology in a less crowded space, if you will by diverting our attention to Parkinson’s disease.
 
Some of the foundations, such as the Michael J. Fox Foundation, have specific initiatives targeting biomarker development, because this is such a lacking area within the diagnosis and treatment of the disease.
 
What are some of the challenges of entering the neurodegenerative space?
 
The challenges are pretty significant. One of the reasons we decided to apply the technology to the IVF area is because the hurdles are much less. The regulatory barrier is more defined, the costs of clinical trials are much less. In the Parkinson’s area it is a very challenging regulatory path that one has to engage and clearly it’s going to take an awful lot more money for us as a start-up company to play in that marketplace than in it is to play in the reproductive health marketplace.
 
So one of our goals has been to try to develop some partnership arrangements with some of the companies in big pharma who have franchises in neurodevelopment and hopefully we can collaborate with some of them in the development of the technology in a more significant way.

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