IRVINGTON, NY--(Marketwire - June 14, 2011) - MELA Sciences (NASDAQ: MELA) today announced that it applauds the U.S. Food and Drug Administration's (FDA) renewed focus on preventing and treating melanoma, the deadliest form of skin cancer. The company urges the agency to show similar support of tools to aid dermatologists in detecting melanoma at its earliest, most curable stages.
"Today's FDA action to more effectively regulate sunscreen product labeling and the March approval of the first late-stage melanoma treatment are both tremendous steps forward for this deadly disease and we applaud the agency for these actions," said Joseph V. Gulfo, MD, President and CEO of MELA Sciences. "However, it's an established fact that early melanoma detection is the best, most effective way to save lives from this form of skin cancer that currently kills one American every hour. We urge the agency to place equal emphasis and urgency on the need for better early melanoma detection tools."
Gulfo noted that the FDA has been reviewing sunscreen regulation since 1978. "The American people cannot afford to wait 30 years for similar initiatives to help dermatologists detect skin cancer when it is curable," he said.
Earlier today, the FDA announced that sunscreen products meeting modern standards for effectiveness must be labeled with new information to help consumers find products that, when used with other sun protection measures, help prevent sunburn and reduce the risk of skin cancer and early skin aging. In March, the agency approved the intravenous drug, ipilimumab, for use in late-stage melanoma patients who failed other courses of treatment. The ipilimumab approval was based on a clinical study that showed a four-month improvement in survival overall.
MELA Sciences developed MelaFind® to serve as a tool to help dermatologists detect melanoma at its earliest, most curable stages. Clinical literature shows that approximately 25% or more of these early lesions are being missed with current detection techniques. In the largest clinical trial ever conducted in melanoma detection, MelaFind detected 98.3% of the melanomas, missing fewer than 2% of the early melanomas.
Based on this positive data, the company submitted a Premarket Approval application (PMA) for MelaFind to the FDA over two years ago, yet no final decision has been made.
In its earliest stage, melanoma is limited to the epidermis, the outer layer of skin and the cure rate with surgical removal is virtually 100%.(i) With early detection, surgical removal alone is usually the only required treatment. However, the five year survival rate for patients with stage IV melanoma is less than 15%, with most patients dying within six to ten months.(ii)
Detecting early melanoma not only translates to better results for patients, it also reduces overall healthcare costs. If diagnosed early, dermatologists excise melanoma at a cost of approximately $1,800 per patient. Treatment costs increase dramatically as the melanoma progresses, costing close to $170,000 per patient for late stage melanoma.(iii)
Last month, MELA Sciences filed a Citizen Petition requesting involvement of FDA Commissioner, Margaret Hamburg, in the review of MelaFind urging her to ensure that the PMA review is conducted with fidelity to FDA laws, regulations and guidelines.
"Because we understand the significant need for better early melanoma detection tools, we took extraordinary steps to ensure that the MelaFind PMA would be reviewed in a transparent and efficient manner," Dr. Gulfo said. "We entered into a binding protocol agreement with the FDA prior to designing our clinical trial. We enrolled more patients into our pivotal study than any prospective trial ever conducted in melanoma detection. We believe we satisfied all of the clinical requirements laid out in the protocol agreement."
If MelaFind is approved, MELA Sciences will dedicate itself to educational initiatives aimed at increasing awareness of melanoma prevention and early detection. The company will also create jobs at its Irvington headquarters and throughout the US, as it builds its marketing team and direct sales force to sell the system directly to dermatologists after a potential approval.
About MELA Sciences, Inc:
MELA Sciences is a medical technology company focused on developing MelaFind®, a non-invasive and objective multi-spectral computer vision system intended to aid in the detection of early melanoma. MELA Sciences designed MelaFind® to assist in the evaluation of clinically atypical pigmented skin lesions, when a dermatologist chooses to obtain additional information before making a final decision to biopsy to rule out melanoma. MelaFind® acquires and displays multi-spectral (from blue to near infrared) and reconstructed RGB digital images of pigmented skin lesions and uses automatic image analysis and statistical pattern recognition to help identify lesions to be considered for biopsy to rule out melanoma, the deadliest form of skin cancer. Although no cure is currently available for advanced-stage melanoma, melanoma is virtually 100% curable if caught early.
MelaFind® Proposed Indications for Use
MelaFind® is indicated for the evaluation of clinically atypical cutaneous pigmented lesions (those having one or more clinical or historical characteristics of melanoma, such as asymmetry, border irregularity, color variegation, diameter greater than 6 mm, evolving, patient concern, regression, and "ugly duckling"), when a dermatologist chooses to obtain additional information before making a final decision to biopsy to rule out melanoma. MelaFind® is a non-invasive and objective multi-spectral computer vision system designed as a tool to aid dermatologists in the detection of early (e.g., non-ulcerated, not bleeding, or less than 2.2 cm in diameter) melanoma.
MelaFind® is not a screening device and is not indicated for non-pigmented lesions, banal pigmented lesions, lesions that are clinically identified as definite melanomas, or lesions on special anatomical sites (i.e., acral, mucosal, subungual).
Regulatory Status
The MelaFind® Pre-Market Approval (PMA) application was filed with the FDA in June 2009, received positive FDA Advisory Panel recommendations in November 2010 and is currently under review at the FDA. In February 2011, the Company filed an amendment to the MelaFind® PMA application with the FDA, limiting the indication for use to dermatologists. MELA Sciences cannot predict either the timing of the FDA's decision on the PMA application or the outcome. FDA approval is required prior to marketing MelaFind® in the United States.
For more information on MELA Sciences, visit www.melasciences.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," "assumes," "predicts" 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 known and unknown 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 financial, economic, business, competitive, market, regulatory and political factors or conditions affecting the company and the medical device industry in general, as well as more specific risks and uncertainties facing the company such as those set forth in its reports on Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission (the "SEC"). Factors that might cause such a difference include whether the data from our pre-clinical studies and clinical trials is sufficient to support regulatory approval of MelaFind®, whether we are required to provide the FDA with additional data or perform additional testing on MelaFind® or, even if we do receive regulatory approval, whether any such approval is for the indications we seek. Given the uncertainties affecting companies in the medical device industry such as the company, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. The company urges you to carefully review and consider the disclosures found in its filings with the SEC which are available at www.sec.gov and www.melasciences.com.
(i) American Academy of Dermatology (http://www.aad.org/public/publications/pamphlets/sun_malignant.html)
(ii) Tsao H, Atkins MB, Sober AJ. Management of Cutaneous Melanoma. N Engl J Medicine. 2004;251(10):998-1012
(iii) Alexandrescu D, Dermatology On-Line Journal. Melanoma Costs: A dynamic model for comparing estimated overall costs of various clinical stages. 15(11): 1, 2009
For more information contact
MELA Sciences
646-871-8485
Digg this
Bookmark with del.icio.us
Add to Newsvine
