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Electro-Optical Sciences Announces Positive Top-Line Results From Landmark MelaFind(R) Pivotal Trial
Company to File PMA Application With FDA; Largest Prospective Clinical Study Ever Conducted in Melanoma Detection; Company to Host Conference Call at 8:30 a.m. EST Friday
| Source: Electro-Optical Sciences, Inc.
IRVINGTON, NY--(Marketwire - February 13, 2009) - Electro-Optical Sciences, Inc. ("EOS")
(NASDAQ : MELA ) today announced positive top-line results of its pivotal
trial of MelaFind, a non-invasive, point-of-care instrument to assist in
the early detection of melanoma, the deadliest form of skin cancer. The
blinded study, conducted at seven centers across the US, included 1,831
pigmented skin lesions from 1,383 patients, making this the largest
prospective study ever conducted in melanoma detection. EOS is working to
complete its Pre-Market Approval (PMA) application and expects to file it
with the US Food and Drug Administration (FDA) shortly.
"MelaFind appears to be an excellent tool to help detect melanoma at the
earliest, most treatable stage," said Gary D. Monheit, MD, Associate
Clinical Professor of Dermatology at the University of Alabama in
Birmingham and the lead investigator for the MelaFind pivotal trial. "With
no cure for late stage melanoma, early detection is our best defense
against this cancer, which has reached epidemic proportions."
Prior to the start of the study, EOS and the FDA entered into a binding
protocol agreement to stipulate the sensitivity and specificity endpoints
that should be used to determine the safety and effectiveness of MelaFind.
MelaFind detected 112 of 114 (98% sensitivity; lower confidence bound of
95%) melanomas that were eligible and evaluable for primary sensitivity
endpoint analysis, and 125 of 127 (98% sensitivity; lower confidence bound
greater than 95%) melanomas overall. The protocol agreement calls for
sensitivity endpoints of greater than 95% lower confidence bound(footnote
1).
MelaFind's specificity, the ability to accurately rule out disease, was
significantly superior (9.5%) to that of the study dermatologists (3.7%),
who are skin cancer experts (p-value less than 0.02). The protocol
agreement calls for MelaFind to be more specific than the study physicians
at a p-value(footnote 2) of less than 0.05.
Almost half of the melanomas in the study were melanoma in situ, the most
curable yet most difficult form of melanoma to detect.
"These clinically compelling data suggest that MelaFind may help detect
melanoma earlier, and more accurately differentiate many of the
non-malignant lesions that mimic melanoma," said Darrell Rigel, MD,
Clinical Professor of Dermatology at New York University Medical School.
"This should lead to improved biopsy efficiency and help reduce the number
of unnecessary biopsies, which can be painful and scarring."
The skin cancer experts who participated in this study had previously made
the decision to biopsy all 1,831 pigmented skin lesions prior to enrolling
the patients in the MelaFind clinical trial.
In order to generate a comparison with dermatologists' ability to
accurately detect melanoma, EOS conducted a parallel pilot readers' study
with a different group of 39 dermatologists. Using images and clinical
histories of 23 randomly-selected melanomas from the pivotal study, this
group of dermatologists, on average, would have decided to biopsy only
approximately 18 (80%) of the melanomas, whereas the MelaFind result would
have led to a biopsy of 22 of the melanomas (biopsy sensitivity of 96%). A
larger readers' study to provide additional data regarding the sensitivity
of MelaFind relative to physicians will commence shortly. Data from these
studies will be submitted to the FDA.
"We are extremely pleased with the outcome of the pivotal study and are now
focused on completing our PMA to submit to the FDA as quickly as possible,"
said Joseph V. Gulfo, MD, President and CEO of EOS. "Our mission with
MelaFind has always been to provide a useful tool to aid in detecting
melanoma at its earliest, most curable stage. We look forward to discussing
these data with the agency."
The company chose the final classification algorithm based on its success
at identifying melanomas in a series of large, blinded and sequential
internal classifier selection studies conducted immediately prior to the
analysis of the pivotal trial data. Including the pivotal trial, the
MelaFind classifier successfully detected 430 of the 432 melanomas against
which it was tested.
There were no adverse events associated with the use of MelaFind.
The FDA has notified EOS that the MelaFind PMA will receive Expedited
Review once the application is submitted. EOS plans to submit the findings
from the pivotal study and the readers' studies to peer-reviewed journals
for publication.
MelaFind uses 10 different wavelengths of light to see where a clinician
cannot -- up to 2.5 millimeters below the skin's surface. Using advanced
algorithms, trained and developed on a database of 9,000 pigmented skin
lesions and over 600 melanomas, including those from the pivotal study, the
system provides an immediate result that informs the decision to biopsy.
Conference Call Information
EOS will host a conference call on Friday, February 13 at 8:30 am EST. To
participate, please dial 800-299-7089 fifteen minutes before the conference
is scheduled to begin. Callers outside of the U.S. should dial
+617-801-9714. The conference call passcode is "Electro Optical Sciences."
A live webcast of this call will be available in the investor relations
section of www.eosciences.com. A webcast replay of the call will be
available for one month on the company's website, or until February 27,
2009 by dialing
888-286-8010. Callers outside of the US should dial +617-801-6888. The
replay participant code is 52141913.
About Melanoma
Melanoma is the deadliest form of skin cancer, responsible for
approximately 80% of skin cancer fatalities. The melanoma rate has
continued to increase with an estimated 120,000 new cases projected in
2009. A recent National Cancer Institute report published in the July 10
online edition of the Journal of Investigative Dermatology indicates that
annual incidence of melanoma among young adult Caucasian women rose 50%
between 1980 and 2004. Melanoma is the most common cancer in women age 25
to 29 and the number one cancer killer of women age 30 to 35. Although no
cure is currently available for advanced-stage melanoma, if caught early,
melanoma is virtually 100% curable.
About Electro-Optical Sciences
EOS is a medical device company focused on designing and developing a
non-invasive, point-of-care instrument to assist in the early detection of
melanoma. MelaFind features a hand-held imaging device that emits light of
multiple wavelengths to capture images of suspicious pigmented skin lesions
and extract data. Using sophisticated algorithms, the data are then
analyzed against a proprietary database of melanomas and benign lesions in
order to provide information to assist in the determination of whether the
lesion should be biopsied.
For more information on EOS, visit www.eosciences.com.
Safe Harbor
This press release includes "forward-looking statements" within the meaning
of the Securities Litigation Reform Act of 1995. These statements include
but are not limited to our plans, objectives, expectations and intentions
and other statements that contain words such as "expects," "contemplates,"
"anticipates," "plans," "intends," "believes" and variations of such words
or similar expressions that predict or indicate future events or trends, or
that do not relate to historical matters. These statements are based on our
current beliefs or expectations and are inherently subject to significant
uncertainties and changes in circumstances, many of which are beyond our
control. There can be no assurance that our beliefs or expectations will be
achieved. Actual results may differ materially from our beliefs or
expectations due to economic, business, competitive, market and regulatory
factors.
(footnote 1) A lower confidence bound of greater than 95% indicates that if
the study were repeated, there would be less than a 5% chance that the
sensitivity would be below 95%.
(footnote 2) A p-value of less than 0.05 indicates a less than 5%
probability that the observed difference was due to chance.