Rosetta Genomics Provides Product Pipeline Update
Leveraging World-Class microRNA Biomarker Platform to Advance
Proprietary Technologies in Diagnostics and Therapeutics; Plans to
Launch One New Product Each Year Commencing in 2015
PRINCETON, NJ and REHOVOT, ISRAEL--(Marketwired - Mar 12, 2014)
- Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer
and provider of microRNA-based molecular diagnostics, announces
details regarding the Company's plans to advance its proprietary
microRNA platform technologies in diagnostics and
therapeutics.
"Rosetta Genomics continues to set the pace in developing and
commercializing microRNA-based technologies. We have the most
validated microRNA biomarker platform with approximately 50
peer-reviewed publications relating to our platform and have
recently rejuvenated our research and development efforts to
leverage this leading and versatile platform," stated Kenneth A.
Berlin, President and Chief Executive Officer of Rosetta
Genomics. "We are moving forward on a variety of important
projects to provide clinicians with better tools to improve
patients' lives in a number of areas of unmet medical need with an
aim to commercialize one new assay per year commencing in
2015."
Diagnostics
Building upon the Company's four current commercial diagnostic
assays, Rosetta is advancing several new diagnostic assays starting
with our lead assay for the differential diagnosis of thyroid
neoplasia. In addition, we are evaluating several assays for other
cancers as well as assays for non-invasive diagnosis of chronic
kidney rejection; the early diagnosis and risk stratification of
heart failure patients; and the early diagnosis and differentiation
of Alzheimer's disease.
Thyroid neoplasia
differential diagnosis
Rosetta is discovering tissue-based microRNA biomarkers in order
to develop a new assay for the differential diagnosis of
indeterminate thyroid Fine Needle Aspirate (FNA) samples.
An estimated 4% to 7% of the general population develops nodules
in the thyroid that can be felt on examination, though fewer than
10% are malignant. An FNA to obtain tissue for analysis is the
standard technique for detecting cancer. It is estimated that
nearly 500,000 FNAs are performed each year in the U.S. and
approximately 740,000 are performed annually in Europe.
Interpretation of FNA samples is not always straightforward,
leading to an indeterminate result in up to 30% of the samples.
Many patients with indeterminate results are sent to surgery as a
precaution, despite the fact that the majority of these cases are
benign. This exposes patients to unnecessary surgical risk and
costs the system hundreds of millions of dollars.
Rosetta is developing a thyroid neoplasia assay that has the
potential to improve clinical management in a cost-effective manner
by reducing the number of unnecessary surgeries.
Results from initial studies demonstrated that microRNA
expression levels can differentiate malignant nodules from benign
nodules, and also demonstrated the ability to extract and profile
microRNAs from thyroid FNAs, in various sample types and in a way
consistent with common clinical practices. Rosetta is
currently commencing larger studies and anticipates launching this
assay prior to the end of 2015.
Other
cancers
In addition to the thyroid neoplasia diagnostic, Rosetta is
seeking to expand its oncology diagnostic testing services to
leverage its growing commercial infrastructure. The Company is
evaluating the results of two studies relating to an assay for
bladder cancer risk of invasiveness. In addition, the Company
is evaluating results from an earlier study relating to predicting
treatment response in ovarian cancer patients. Finally, in the
area of breast cancer, Rosetta is evaluating the unmet needs here
and is in discussion with potential collaborators regarding the
development of assays that could aid clinicians in patient
management. Diagnostics for each of these indications are
important, as the information they supply will directly affect
treatment choices and patient outcomes. Rosetta is evaluating
next steps in each of these important oncology indications as it
seeks to leverage the investments it is making in its commercial
oncology infrastructure over a larger number of cancer products
with the goal of launching at least one assay for an oncology
indication prior to the end of 2016. In addition, our core
research continues to enhance and expand the range and clinical
utility of our current products for better diagnostic guidance of
therapeutic strategies in difficult metastatic cancers, and lung
and kidney cancers. These efforts leverage methodological
advances from new test research as well as our clinical lab
experience.
Non-invasive
diagnosis of chronic kidney rejection
Kidney transplantation is widely accepted as the treatment of
choice for end-stage renal disease. The number of patients
receiving renal replacement therapy worldwide is estimated at more
than 1.4 million and is growing by approximately 8% annually.
Advances in post-transplant care including the introduction of new
potent immunosuppressive drugs have led to a dramatic decrease in
acute kidney rejection. However, long-term stable graft function
remains elusive, and in the past decade, progressive chronic
deterioration, or chronic rejection, and the resulting inevitable
graft loss has become a major problem in organ transplantation.
The incidence of rejection is high, at a rate of 30% of all
grafts in the first post-transplant year, progressing to 50% in
year five and reaching nearly 100% of functioning grafts 10 years
after transplantation. Chronic rejection is currently diagnosed
only by histological examination of a tissue sample obtained by
biopsy, which is expensive, unpleasant for the patient and
unsuitable for serial clinical use due to the risk of bleeding and
other complications. Furthermore, morphological changes may be
patchy, difficult to interpret and subject to observer bias.
Therefore, it is widely accepted that measurement of chronic graft
injury is imprecise.
Rosetta is commencing work on developing blood- or urine-based
microRNA biomarkers to advance a new diagnostic test for chronic
kidney rejection. This non-invasive test has the potential to
enable diagnosis at an earlier stage when this information could
alter the choice of therapy and, ultimately, improve
outcomes. Rosetta expects to complete development of and
launch this assay in 2017.
Heart
failure
Rosetta is evaluating results from its two studies relating to
blood-based microRNA biomarkers to advance a new diagnostic assay
for the early diagnosis of heart failure (HF) and refined risk
stratification of patients following myocardial infarction (MI, or
heart attack).
HF is the most prevalent disease in the western world and is the
only cardiovascular disease whose prevalence continues to rise. The
worldwide prevalence of HF is estimated to be 23 million; with 6.6
million in the U.S. HF is one of the most expensive diseases in
western countries, with costs to the U.S. healthcare system
estimated at $31 billion in 2012.
The Company has two supportive studies published. The first
was published in the European Journal of Heart Failure
(Goren et al., 2012) and showed that elevated serum levels of
specific microRNAs identify HF patients. The second was published
in the American Journal of Cardiology (Goren et al., 2013)
and showed a significant reduction in the level of a specific
microRNA (miR-150) in platelets of HF patients that also suffered
atrial fibrillation (heart rhythm disorder).
Rosetta is planning to conduct additional studies aimed at
further examining the expression of the identified microRNA
biomarkers in various blood fractions and anticipates launching a
new assay in HF in 2017.
Alzheimer's
disease
New and expensive drug therapies are expected to increase the
need for and value of early diagnosis in Alzheimer's disease
(AD). Rosetta has profiled serum samples of AD patients in
comparison to serum samples healthy controls and identified that
several microRNAs in AD blood maintained their direction when
compared between AD brain and brain cancer tissue. Rosetta
plans to conduct a proof-of-concept study in additional cohorts in
order to profile differentially expressed microRNAs in the
cerebrospinal fluid of AD patients compared with normal donors
using deep sequencing. The Company expects to advance studies
relating to this project in 2014.
Therapeutics
microRNAs represent potential targets for the development of
novel drugs and there are now at least two drugs targeting
microRNAs that are in clinical studies by other companies.
Rosetta's therapeutics pipeline has three distinct projects
including one aimed at developing a microRNA-based therapeutic for
cytomegalovirus (CMV) infection and two government-assisted
projects focused on the development of novel technologies for the
delivery of microRNA-based therapeutics.
CMV
therapeutic
microRNAs are abundant among various organisms including DNA
viruses of the herpes virus family (e.g., CMV). Viral microRNAs may
directly regulate viral genes, could target host genes and are
involved in viral replication and in assisting the virus evade the
host immune system.
Human CMV is a widespread pathogen that infects the majority of
the world's population by early adulthood. Human CMV can be the
cause of morbidity and mortality in populations with immature or
compromised immune systems. With 30,000 infants born with
congenital CMV annually in the U.S., it is the leading viral cause
of birth defects where infection of neonates causes deafness and
mental retardation. CMV affects 90-95% of HIV-infected
patients and is the major cause of retinitis and blindness in AIDS
patients. Human CMV contributes to graft loss in bone marrow
and solid organ transplants, causes disease in cancer patients
receiving immunosuppressive chemotherapy and likely contributes to
age-associated immunesenescence.
There is a pressing medical need for novel therapeutics for CMV
infection as there is no vaccine to prevent it and FDA-approved
drugs for the treatment of CMV suffer from low bioavailability,
toxicity and the formation of resistant viruses. According to
GlobalData, the CMV drug market is expected to grow to $1.2 billion
by 2019 from $685.5 million in 2011.
Rosetta is in the discovery stage of a project aimed at
developing a microRNA-based therapeutic for the treatment of human
CMV infection. Rosetta's researchers have identified several viral
microRNA candidates and have prepared a library of microRNA
mimetics as well as specific inhibitors of these microRNAs. The
Company is studying the effect of the library compounds on viral
replication and infectivity.
Rosetta anticipates selecting a lead candidate in the third
quarter of 2014 and is considering various alternative routes to
market, including through or with third parties, for further
preclinical and clinical development.
Rimonim and
Magneton projects
The Rimonim and Magneton projects aim at developing novel
technologies for the effective delivery of microRNA mimetics for
therapeutics. Both projects are supported by the Office
of Chief Scientist at the Ministry of Industry, Trade and Labor of
the State of Israel (OCS). If successful, Rosetta will seek to use
these technologies for future internal projects as well as to
partner them with other therapeutics companies.
"Our microRNA platform technologies are extremely versatile and
we have developed a robust pipeline of opportunities. Our
ongoing goal is to leverage our leading platform in microRNA
biomarker technology to bring innovative diagnostics and
therapeutics to patients in need, while creating the potential for
new revenue sources for the Company. We plan on building our
robust pipeline to leverage our investments in oncology, while
expanding our microRNA technologies into much larger indications
such as heart failure and Alzheimer's disease. We will invest
and advance programs on our own in certain indications and expect
to collaborate, partner or license our technologies and products in
others," concluded Mr. Berlin.
About Rosetta Cancer Testing Services Rosetta Cancer Tests are a
series of microRNA-based diagnostic testing services offered by
Rosetta Genomics. The Rosetta Cancer Origin Test™ can accurately
identify the primary tumor type in primary and metastatic cancer
including cancer of unknown or uncertain primary (CUP). Rosetta
Mesothelioma Test™ diagnoses mesothelioma, a cancer connected to
asbestos exposure. The Rosetta Lung Cancer Test™ accurately
identifies the four main subtypes of lung cancer using small
amounts of tumor cells. The Rosetta Kidney Cancer Test™ accurately
classifies the four most common kidney tumors: clear cell renal
cell carcinoma (RCC), papillary RCC, chromophobe RCC and
oncocytoma. Rosetta's assays are designed to provide objective
diagnostic data; it is the treating physician's responsibility to
diagnose and administer the appropriate treatment. In the U.S.
alone, Rosetta Genomics estimates that 200,000 patients a year may
benefit from the Rosetta Cancer Origin Test™, 60,000 from the
Rosetta Mesothelioma Test™, 65,000 from the Rosetta Kidney Cancer
Test™ and 226,000 patients from the Rosetta Lung Cancer Test™. The
Company's assays are offered directly by Rosetta Genomics in the
U.S., and through distributors around the world. For more
information, please visit www.rosettagenomics.com. Parties
interested in ordering the test can contact Rosetta Genomics at
(215) 382-9000 ext. 309.
About Rosetta Genomics Rosetta develops and commercializes a
full range of microRNA-based molecular diagnostics. Founded in
2000, Rosetta's integrative research platform combining
bioinformatics and state-of-the-art laboratory processes has led to
the discovery of hundreds of biologically validated novel human
microRNAs. Building on its strong patent position and proprietary
platform technologies, Rosetta is working on the application of
these technologies in the development and commercialization of a
full range of microRNA-based diagnostic tools and therapeutics.
Rosetta's cancer testing services are commercially available
through its Philadelphia-based CAP-accredited, CLIA-certified
lab. Frost & Sullivan recognized Rosetta Genomics with the
2012 North American Next Generation Diagnostics Entrepreneurial
Company of the Year Award.
Forward-Looking Statement Disclaimer Various statements in this
release concerning Rosetta's future expectations, plans and
prospects, including without limitation, Rosetta's aim to
commercialize one new assay per year commencing in 2015, as well as
the timeline for launching new assays (including launch of a
thyroid neoplasia assay by the end of 2015, launch of an oncology
assay by the end of 2016, launch of an assay for chronic kidney
rejection in 2017, and launch of an HF assay in 2017), the timing
of development of an assay for early diagnosis of AD, the expected
growth of the CMV drug market, anticipation of selecting a lead CMV
drug candidate in the third quarter of 2014, and Rosetta's
development of novel technologies for the effective delivery of
microRNA mimetics for therapeutics, constitute forward-looking
statements for the purposes of the safe harbor provisions under The
Private Securities Litigation Reform Act of 1995. Actual results
may differ materially from those indicated by these forward-looking
statements as a result of various important factors, including
those risks more fully discussed in the "Risk Factors" section of
Rosetta's Annual Report on Form 20-F for the year ended December
31, 2012 as filed with the SEC. In addition, any forward-looking
statements represent Rosetta's views only as of the date of this
release and should not be relied upon as representing its views as
of any subsequent date. Rosetta does not assume any obligation to
update any forward-looking statements unless required by law.
Company Contact: Rosetta Genomics Ken Berlin President & CEO
(609) 419-9003 investors@rosettagenomics.com Investor Contacts: LHA
Anne Marie Fields (212) 838-3777 afields@lhai.com or Bruce Voss
(310) 691-7100 bvoss@lhai.com
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