Electron Beam Radiation Therapy May Reduce Need For Invasive Surgeries, Post-Op Radiation Treatment
The Mobetron, the first fully portable, self-shielding intra-operative electron radiation therapy device, from IntraOp Medical Corporation (Sunnyvale, Calif.), can now be used to provide non-surgical radiation therapy to skin cancer patients in any operating room, including in the office setting, The only FDA-approved self-shielding device, the Mobetron is typically used to deliver intraoperative electron-beam radiation therapy (IOERT) to cancer patients at the time of surgery, in many cases eliminating the need for post-operative radiation treatment. According to company literature, radiation therapy treatment has cure rates comparable to surgery for all forms of basal and squamous cell skin cancers, making it an attractive alternative for many skin cancer patients. It can also be used for cosmetic treatments, such as the removal of keloid scars. Its benefits are said to include increased survival rates, better local tumor control, shorter treatment cycles, and fewer side effects, as well as an ability to provide desirable cosmetic outcomes for patients in an office setting to potentially reduce the need for invasive skin cancer surgeries. The Mobetron is currently in use at more than 26 hospitals around the world, including eight in the United States. _____________________________
Defense Department Seeks Funds for Skin Cancer Research
According to a press release from the Melanoma Research Foundation (MRF), the Department of Defense is seeking $4 million to be dedicated to research efforts on melanoma and other skin cancers, which pose a danger to many military personnel. “With more than 140,000 personnel currently stationed in Iraq, the intensity of sun exposure puts our men and women at long-term risk for melanoma, the most serious form of skin cancer and one of the fastest growing cancers in the U.S.,” said Randy Lomax, chairman of the MRF. “By specifically including melanoma in its peer-reviewed cancer research program — as it does with breast, prostate and ovarian cancers — the Department of Defense recognizes the scope of this very serious problem facing our troops.” “Increased funding, especially at the federal levels, for research is critical to finding a cure given the very real opportunities available for developing new and meaningful therapies, especially for those with advanced melanoma,” said Dr. David E. Fisher, Chief of Dermatology at Massachusetts General Hospital and a member of the MRF’s Scientific Advisory Committee. “Becoming part of the Defense Department’s Congressionally Directed Medical Research Programs is a major victory for the thousands of people living with melanoma and our veterans who may develop it.” The request, part of the Fiscal 2009 Department of Defense Appropriations Conference Report, is now under consideration by the United States House of Representatives. _____________________________
Study Finds Less Frequent Dosing Of Imiquimod 5% Effective For Actinic Keratoses
A placebo-controlled, double-blind, randomized pilot study of imiquimod 5% cream applied once per week for 24 weeks — instead of twice weekly for 16 weeks — found the less frequent dosing to be effective for actinic keratoses with minimal side effects. The study was undertaken by investigators at Mount Sinai Medical Center, New York, to determine if the once-daily treatment would be effective, given the limitations of twice-weekly dosing for 16 weeks due to local side effects. Study Design and Outcome Using a left versus right side of the head design, investigators enrolled 20 patients; 15 completed and five discontinued for reasons unrelated to adverse events. At the post-treatment visit (week 28), 7 (46.7%) of 15 patients had marked improvement or better on the imiquimod side versus one (6.7%) of 15 on the placebo side. The average investigator assessment scale score change was +2.20 for imiquimod compared with -0.27 for placebo (P = .0002, Wilcoxon signed rank test). Skin reactions were minimal or nonexistent in most patients. Investigators noted that study limitations included its small sample size and the lack of objective measure of local side effects. _____________________________
Family History of Melanoma Doubles Parkinson's Risk
A group of researchers led by Dr. Xiang Gao, an instructor in medicine at Harvard University School of Public Health, study found that people with a family history of melanoma are twice as likely to develop Parkinson's disease, and further suggested a previously reported link between melanoma and Parkinsons disease may be genetic. While the reasons for this association are not clear, earlier studies had found that Parkinson’s patients taking levodopa, a common treatment for the condition, were more susceptible to melanoma, Dr. Gao said. “They thought that levodopa increased the risk of melanoma,” he explained. But later reports found that people with melanoma were at high risk of developing Parkinson’s disease, Dr. Gao said. “This suggests that it may not be the drugs, it could be something else, which is why I did this study,” he said. Study Design and Results Dr. Gao’s team collected data on almost 157,000 men and women who did not have Parkinson’s disease. These individuals participated in the Health Professional Follow-up Study and the Nurses Health Study. During 14 years of follow-up, 616 people developed Parkinson's disease. Among those people who also reported a family history of melanoma, the risk for developing Parkinson's disease was doubled, the researchers found. After adjusting for other factors such as colorectal, lung, prostate or breast cancer as well as age, smoking or caffeine consumption, only the association between melanoma and Parkinson’s disease was significant, the researchers reported. _____________________________
Melanoma Research Foundation Awards Grants to Five Melanoma Researchers
The Melanoma Research Foundation (MRF) announced the recipients of five research grants as part of its Career Development Grant Program and Established Investigator Grant Program. The MRF’s Research Grant Programs support medical research that furthers the development of effective treatments and a possible cure for malignant melanoma, while encouraging scientists and clinicians to join in its mission. The Career Development Grant provides funding of up to $50,000 per year for 2 years to investigators who are beginning a research career emphasizing melanoma-related projects. The MRF’s Established Investigator Grant provides funding of up to $100,000 per year for 2 years to established researchers in melanoma or those who wish to move into melanoma research. Grant recipients are selected through a scientific, peer-reviewed system composed of leading clinical and pre-clinical melanoma researchers. This year’s recipients include: Dr. Vitali Alexeev, Thomas Jefferson University, “MicroRNA in regulation and targeting of the cKit receptor in malignant melanoma.” Dr. Ed Harlow, Harvard Medical School, “Requirements for MITF-dependent melanomas: identification of novel drug targets.” Dr. SubbaRao Madhunapantula, Pennsylvania State University College of Medicine, “Targeting Kinases to Treat Melanoma.” Dr. Vladislava Melnikova, The University of Texas MD Anderson Cancer Center, “Regulation of Melanoma Metastasis by the Tumor Microenvironment: The Role of Platelet Activating Factor (PAF) and PAF Receptor.” Dr. Keiran Smalley, The Moffitt Cancer Center and Research Institute, “Targeted therapy for melanoma.” To learn more about donating to MRF and its research programs, please visit www.melanoma.org. _____________________________
Early Study Results Positive on Non-invasive Melanoma Detection Device
In the largest prospective clinical study ever conducted in melanoma detection, Electro-Optical Sciences, Inc. (Irvington, NY), reported positive top-line results on its trial of MelaFind, a non-invasive, point-of-care instrument to assist in the early detection of melanoma. The blinded study, conducted at seven centers across the United States, included 1,831 pigmented skin lesions from 1,383 patients, making this the largest prospective study ever conducted in melanoma detection. These early findings suggest that this non-invasive device could be a useful tool in detecting melanoma at its earliest, most curable stage. MelaFind Description According to the company, MelaFind uses 10 different wavelengths of light to see up to 2.5 millimeters below the skin’s surface It also uses advanced algorithms, trained and developed on a database of 9,000 pigmented skin lesions and more than 600 melanomas, including those from the pivotal study. The MelaFind system then analyzes the characteristics of the mole to help the clinician decide whether or not to biopsy. Protocol Agreement 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. MelaFind’s specificity was significantly superior (9.5%) to that of the study dermatologists (3.7%) (p-value < 0.02). The protocol agreement calls for MelaFind to be more specific than the study physicians at a p-value 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. 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. Parallel Pilot Readers’ Study 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 about 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. Outcomes 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. Next Steps EOS expects to soon file its Pre-Market Approval application with the FDA and has been notified that the MelaFind PMA will receive Expedited Review once the application is submitted. Findings from the pivotal study and the readers’ studies will be submitted to peer-reviewed journals for publication. _____________________________
NEW SUNSCREEN WIPES OFFER MORE CONVENIENT UV PROTECTION
The recent introduction of La Fresh Sunscreen Wipes, by La Fresh Group (Ontario, Calif.) may make it easier for many patients to take their dermatologists’ sun protection advice. In fact, some dermatologists could do well to follow the example of their colleague Dr. Kathryn Zeoli, of Pembroke Pines, FL, who says, in her 23 years in practice, has tried nearly everything to encourage sunscreen use among her patients. She recently achieved some success in this goal after placing a basket of the single-use SFP 30 wipes in the waiting room of her office. She finds her patients have been taking them on their way out and report that they are using them, largely because they’re convenient. “It’s not convenient to carry around a bottle of sunscreen, but sunscreen wipes can fit into your wallet or pocket. As long as they use sunscreen, I’m happy,” she says. The single-use SPF 30 sunscreen towelettes are effective in blocking UVB and UVA rays. According to company literature, the towelettes are made from biodegradable material and are approved by the Transportation Security Administration. For more information on La Fresh Group, visit www.LaFreshGroup.com.
Electron Beam Radiation Therapy May Reduce Need For Invasive Surgeries, Post-Op Radiation Treatment
The Mobetron, the first fully portable, self-shielding intra-operative electron radiation therapy device, from IntraOp Medical Corporation (Sunnyvale, Calif.), can now be used to provide non-surgical radiation therapy to skin cancer patients in any operating room, including in the office setting, The only FDA-approved self-shielding device, the Mobetron is typically used to deliver intraoperative electron-beam radiation therapy (IOERT) to cancer patients at the time of surgery, in many cases eliminating the need for post-operative radiation treatment. According to company literature, radiation therapy treatment has cure rates comparable to surgery for all forms of basal and squamous cell skin cancers, making it an attractive alternative for many skin cancer patients. It can also be used for cosmetic treatments, such as the removal of keloid scars. Its benefits are said to include increased survival rates, better local tumor control, shorter treatment cycles, and fewer side effects, as well as an ability to provide desirable cosmetic outcomes for patients in an office setting to potentially reduce the need for invasive skin cancer surgeries. The Mobetron is currently in use at more than 26 hospitals around the world, including eight in the United States. _____________________________
Defense Department Seeks Funds for Skin Cancer Research
According to a press release from the Melanoma Research Foundation (MRF), the Department of Defense is seeking $4 million to be dedicated to research efforts on melanoma and other skin cancers, which pose a danger to many military personnel. “With more than 140,000 personnel currently stationed in Iraq, the intensity of sun exposure puts our men and women at long-term risk for melanoma, the most serious form of skin cancer and one of the fastest growing cancers in the U.S.,” said Randy Lomax, chairman of the MRF. “By specifically including melanoma in its peer-reviewed cancer research program — as it does with breast, prostate and ovarian cancers — the Department of Defense recognizes the scope of this very serious problem facing our troops.” “Increased funding, especially at the federal levels, for research is critical to finding a cure given the very real opportunities available for developing new and meaningful therapies, especially for those with advanced melanoma,” said Dr. David E. Fisher, Chief of Dermatology at Massachusetts General Hospital and a member of the MRF’s Scientific Advisory Committee. “Becoming part of the Defense Department’s Congressionally Directed Medical Research Programs is a major victory for the thousands of people living with melanoma and our veterans who may develop it.” The request, part of the Fiscal 2009 Department of Defense Appropriations Conference Report, is now under consideration by the United States House of Representatives. _____________________________
Study Finds Less Frequent Dosing Of Imiquimod 5% Effective For Actinic Keratoses
A placebo-controlled, double-blind, randomized pilot study of imiquimod 5% cream applied once per week for 24 weeks — instead of twice weekly for 16 weeks — found the less frequent dosing to be effective for actinic keratoses with minimal side effects. The study was undertaken by investigators at Mount Sinai Medical Center, New York, to determine if the once-daily treatment would be effective, given the limitations of twice-weekly dosing for 16 weeks due to local side effects. Study Design and Outcome Using a left versus right side of the head design, investigators enrolled 20 patients; 15 completed and five discontinued for reasons unrelated to adverse events. At the post-treatment visit (week 28), 7 (46.7%) of 15 patients had marked improvement or better on the imiquimod side versus one (6.7%) of 15 on the placebo side. The average investigator assessment scale score change was +2.20 for imiquimod compared with -0.27 for placebo (P = .0002, Wilcoxon signed rank test). Skin reactions were minimal or nonexistent in most patients. Investigators noted that study limitations included its small sample size and the lack of objective measure of local side effects. _____________________________
Family History of Melanoma Doubles Parkinson's Risk
A group of researchers led by Dr. Xiang Gao, an instructor in medicine at Harvard University School of Public Health, study found that people with a family history of melanoma are twice as likely to develop Parkinson's disease, and further suggested a previously reported link between melanoma and Parkinsons disease may be genetic. While the reasons for this association are not clear, earlier studies had found that Parkinson’s patients taking levodopa, a common treatment for the condition, were more susceptible to melanoma, Dr. Gao said. “They thought that levodopa increased the risk of melanoma,” he explained. But later reports found that people with melanoma were at high risk of developing Parkinson’s disease, Dr. Gao said. “This suggests that it may not be the drugs, it could be something else, which is why I did this study,” he said. Study Design and Results Dr. Gao’s team collected data on almost 157,000 men and women who did not have Parkinson’s disease. These individuals participated in the Health Professional Follow-up Study and the Nurses Health Study. During 14 years of follow-up, 616 people developed Parkinson's disease. Among those people who also reported a family history of melanoma, the risk for developing Parkinson's disease was doubled, the researchers found. After adjusting for other factors such as colorectal, lung, prostate or breast cancer as well as age, smoking or caffeine consumption, only the association between melanoma and Parkinson’s disease was significant, the researchers reported. _____________________________
Melanoma Research Foundation Awards Grants to Five Melanoma Researchers
The Melanoma Research Foundation (MRF) announced the recipients of five research grants as part of its Career Development Grant Program and Established Investigator Grant Program. The MRF’s Research Grant Programs support medical research that furthers the development of effective treatments and a possible cure for malignant melanoma, while encouraging scientists and clinicians to join in its mission. The Career Development Grant provides funding of up to $50,000 per year for 2 years to investigators who are beginning a research career emphasizing melanoma-related projects. The MRF’s Established Investigator Grant provides funding of up to $100,000 per year for 2 years to established researchers in melanoma or those who wish to move into melanoma research. Grant recipients are selected through a scientific, peer-reviewed system composed of leading clinical and pre-clinical melanoma researchers. This year’s recipients include: Dr. Vitali Alexeev, Thomas Jefferson University, “MicroRNA in regulation and targeting of the cKit receptor in malignant melanoma.” Dr. Ed Harlow, Harvard Medical School, “Requirements for MITF-dependent melanomas: identification of novel drug targets.” Dr. SubbaRao Madhunapantula, Pennsylvania State University College of Medicine, “Targeting Kinases to Treat Melanoma.” Dr. Vladislava Melnikova, The University of Texas MD Anderson Cancer Center, “Regulation of Melanoma Metastasis by the Tumor Microenvironment: The Role of Platelet Activating Factor (PAF) and PAF Receptor.” Dr. Keiran Smalley, The Moffitt Cancer Center and Research Institute, “Targeted therapy for melanoma.” To learn more about donating to MRF and its research programs, please visit www.melanoma.org. _____________________________
Early Study Results Positive on Non-invasive Melanoma Detection Device
In the largest prospective clinical study ever conducted in melanoma detection, Electro-Optical Sciences, Inc. (Irvington, NY), reported positive top-line results on its trial of MelaFind, a non-invasive, point-of-care instrument to assist in the early detection of melanoma. The blinded study, conducted at seven centers across the United States, included 1,831 pigmented skin lesions from 1,383 patients, making this the largest prospective study ever conducted in melanoma detection. These early findings suggest that this non-invasive device could be a useful tool in detecting melanoma at its earliest, most curable stage. MelaFind Description According to the company, MelaFind uses 10 different wavelengths of light to see up to 2.5 millimeters below the skin’s surface It also uses advanced algorithms, trained and developed on a database of 9,000 pigmented skin lesions and more than 600 melanomas, including those from the pivotal study. The MelaFind system then analyzes the characteristics of the mole to help the clinician decide whether or not to biopsy. Protocol Agreement 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. MelaFind’s specificity was significantly superior (9.5%) to that of the study dermatologists (3.7%) (p-value < 0.02). The protocol agreement calls for MelaFind to be more specific than the study physicians at a p-value 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. 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. Parallel Pilot Readers’ Study 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 about 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. Outcomes 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. Next Steps EOS expects to soon file its Pre-Market Approval application with the FDA and has been notified that the MelaFind PMA will receive Expedited Review once the application is submitted. Findings from the pivotal study and the readers’ studies will be submitted to peer-reviewed journals for publication. _____________________________
NEW SUNSCREEN WIPES OFFER MORE CONVENIENT UV PROTECTION
The recent introduction of La Fresh Sunscreen Wipes, by La Fresh Group (Ontario, Calif.) may make it easier for many patients to take their dermatologists’ sun protection advice. In fact, some dermatologists could do well to follow the example of their colleague Dr. Kathryn Zeoli, of Pembroke Pines, FL, who says, in her 23 years in practice, has tried nearly everything to encourage sunscreen use among her patients. She recently achieved some success in this goal after placing a basket of the single-use SFP 30 wipes in the waiting room of her office. She finds her patients have been taking them on their way out and report that they are using them, largely because they’re convenient. “It’s not convenient to carry around a bottle of sunscreen, but sunscreen wipes can fit into your wallet or pocket. As long as they use sunscreen, I’m happy,” she says. The single-use SPF 30 sunscreen towelettes are effective in blocking UVB and UVA rays. According to company literature, the towelettes are made from biodegradable material and are approved by the Transportation Security Administration. For more information on La Fresh Group, visit www.LaFreshGroup.com.
Electron Beam Radiation Therapy May Reduce Need For Invasive Surgeries, Post-Op Radiation Treatment
The Mobetron, the first fully portable, self-shielding intra-operative electron radiation therapy device, from IntraOp Medical Corporation (Sunnyvale, Calif.), can now be used to provide non-surgical radiation therapy to skin cancer patients in any operating room, including in the office setting, The only FDA-approved self-shielding device, the Mobetron is typically used to deliver intraoperative electron-beam radiation therapy (IOERT) to cancer patients at the time of surgery, in many cases eliminating the need for post-operative radiation treatment. According to company literature, radiation therapy treatment has cure rates comparable to surgery for all forms of basal and squamous cell skin cancers, making it an attractive alternative for many skin cancer patients. It can also be used for cosmetic treatments, such as the removal of keloid scars. Its benefits are said to include increased survival rates, better local tumor control, shorter treatment cycles, and fewer side effects, as well as an ability to provide desirable cosmetic outcomes for patients in an office setting to potentially reduce the need for invasive skin cancer surgeries. The Mobetron is currently in use at more than 26 hospitals around the world, including eight in the United States. _____________________________
Defense Department Seeks Funds for Skin Cancer Research
According to a press release from the Melanoma Research Foundation (MRF), the Department of Defense is seeking $4 million to be dedicated to research efforts on melanoma and other skin cancers, which pose a danger to many military personnel. “With more than 140,000 personnel currently stationed in Iraq, the intensity of sun exposure puts our men and women at long-term risk for melanoma, the most serious form of skin cancer and one of the fastest growing cancers in the U.S.,” said Randy Lomax, chairman of the MRF. “By specifically including melanoma in its peer-reviewed cancer research program — as it does with breast, prostate and ovarian cancers — the Department of Defense recognizes the scope of this very serious problem facing our troops.” “Increased funding, especially at the federal levels, for research is critical to finding a cure given the very real opportunities available for developing new and meaningful therapies, especially for those with advanced melanoma,” said Dr. David E. Fisher, Chief of Dermatology at Massachusetts General Hospital and a member of the MRF’s Scientific Advisory Committee. “Becoming part of the Defense Department’s Congressionally Directed Medical Research Programs is a major victory for the thousands of people living with melanoma and our veterans who may develop it.” The request, part of the Fiscal 2009 Department of Defense Appropriations Conference Report, is now under consideration by the United States House of Representatives. _____________________________
Study Finds Less Frequent Dosing Of Imiquimod 5% Effective For Actinic Keratoses
A placebo-controlled, double-blind, randomized pilot study of imiquimod 5% cream applied once per week for 24 weeks — instead of twice weekly for 16 weeks — found the less frequent dosing to be effective for actinic keratoses with minimal side effects. The study was undertaken by investigators at Mount Sinai Medical Center, New York, to determine if the once-daily treatment would be effective, given the limitations of twice-weekly dosing for 16 weeks due to local side effects. Study Design and Outcome Using a left versus right side of the head design, investigators enrolled 20 patients; 15 completed and five discontinued for reasons unrelated to adverse events. At the post-treatment visit (week 28), 7 (46.7%) of 15 patients had marked improvement or better on the imiquimod side versus one (6.7%) of 15 on the placebo side. The average investigator assessment scale score change was +2.20 for imiquimod compared with -0.27 for placebo (P = .0002, Wilcoxon signed rank test). Skin reactions were minimal or nonexistent in most patients. Investigators noted that study limitations included its small sample size and the lack of objective measure of local side effects. _____________________________
Family History of Melanoma Doubles Parkinson's Risk
A group of researchers led by Dr. Xiang Gao, an instructor in medicine at Harvard University School of Public Health, study found that people with a family history of melanoma are twice as likely to develop Parkinson's disease, and further suggested a previously reported link between melanoma and Parkinsons disease may be genetic. While the reasons for this association are not clear, earlier studies had found that Parkinson’s patients taking levodopa, a common treatment for the condition, were more susceptible to melanoma, Dr. Gao said. “They thought that levodopa increased the risk of melanoma,” he explained. But later reports found that people with melanoma were at high risk of developing Parkinson’s disease, Dr. Gao said. “This suggests that it may not be the drugs, it could be something else, which is why I did this study,” he said. Study Design and Results Dr. Gao’s team collected data on almost 157,000 men and women who did not have Parkinson’s disease. These individuals participated in the Health Professional Follow-up Study and the Nurses Health Study. During 14 years of follow-up, 616 people developed Parkinson's disease. Among those people who also reported a family history of melanoma, the risk for developing Parkinson's disease was doubled, the researchers found. After adjusting for other factors such as colorectal, lung, prostate or breast cancer as well as age, smoking or caffeine consumption, only the association between melanoma and Parkinson’s disease was significant, the researchers reported. _____________________________
Melanoma Research Foundation Awards Grants to Five Melanoma Researchers
The Melanoma Research Foundation (MRF) announced the recipients of five research grants as part of its Career Development Grant Program and Established Investigator Grant Program. The MRF’s Research Grant Programs support medical research that furthers the development of effective treatments and a possible cure for malignant melanoma, while encouraging scientists and clinicians to join in its mission. The Career Development Grant provides funding of up to $50,000 per year for 2 years to investigators who are beginning a research career emphasizing melanoma-related projects. The MRF’s Established Investigator Grant provides funding of up to $100,000 per year for 2 years to established researchers in melanoma or those who wish to move into melanoma research. Grant recipients are selected through a scientific, peer-reviewed system composed of leading clinical and pre-clinical melanoma researchers. This year’s recipients include: Dr. Vitali Alexeev, Thomas Jefferson University, “MicroRNA in regulation and targeting of the cKit receptor in malignant melanoma.” Dr. Ed Harlow, Harvard Medical School, “Requirements for MITF-dependent melanomas: identification of novel drug targets.” Dr. SubbaRao Madhunapantula, Pennsylvania State University College of Medicine, “Targeting Kinases to Treat Melanoma.” Dr. Vladislava Melnikova, The University of Texas MD Anderson Cancer Center, “Regulation of Melanoma Metastasis by the Tumor Microenvironment: The Role of Platelet Activating Factor (PAF) and PAF Receptor.” Dr. Keiran Smalley, The Moffitt Cancer Center and Research Institute, “Targeted therapy for melanoma.” To learn more about donating to MRF and its research programs, please visit www.melanoma.org. _____________________________
Early Study Results Positive on Non-invasive Melanoma Detection Device
In the largest prospective clinical study ever conducted in melanoma detection, Electro-Optical Sciences, Inc. (Irvington, NY), reported positive top-line results on its trial of MelaFind, a non-invasive, point-of-care instrument to assist in the early detection of melanoma. The blinded study, conducted at seven centers across the United States, included 1,831 pigmented skin lesions from 1,383 patients, making this the largest prospective study ever conducted in melanoma detection. These early findings suggest that this non-invasive device could be a useful tool in detecting melanoma at its earliest, most curable stage. MelaFind Description According to the company, MelaFind uses 10 different wavelengths of light to see up to 2.5 millimeters below the skin’s surface It also uses advanced algorithms, trained and developed on a database of 9,000 pigmented skin lesions and more than 600 melanomas, including those from the pivotal study. The MelaFind system then analyzes the characteristics of the mole to help the clinician decide whether or not to biopsy. Protocol Agreement 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. MelaFind’s specificity was significantly superior (9.5%) to that of the study dermatologists (3.7%) (p-value < 0.02). The protocol agreement calls for MelaFind to be more specific than the study physicians at a p-value 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. 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. Parallel Pilot Readers’ Study 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 about 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. Outcomes 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. Next Steps EOS expects to soon file its Pre-Market Approval application with the FDA and has been notified that the MelaFind PMA will receive Expedited Review once the application is submitted. Findings from the pivotal study and the readers’ studies will be submitted to peer-reviewed journals for publication. _____________________________
NEW SUNSCREEN WIPES OFFER MORE CONVENIENT UV PROTECTION
The recent introduction of La Fresh Sunscreen Wipes, by La Fresh Group (Ontario, Calif.) may make it easier for many patients to take their dermatologists’ sun protection advice. In fact, some dermatologists could do well to follow the example of their colleague Dr. Kathryn Zeoli, of Pembroke Pines, FL, who says, in her 23 years in practice, has tried nearly everything to encourage sunscreen use among her patients. She recently achieved some success in this goal after placing a basket of the single-use SFP 30 wipes in the waiting room of her office. She finds her patients have been taking them on their way out and report that they are using them, largely because they’re convenient. “It’s not convenient to carry around a bottle of sunscreen, but sunscreen wipes can fit into your wallet or pocket. As long as they use sunscreen, I’m happy,” she says. The single-use SPF 30 sunscreen towelettes are effective in blocking UVB and UVA rays. According to company literature, the towelettes are made from biodegradable material and are approved by the Transportation Security Administration. For more information on La Fresh Group, visit www.LaFreshGroup.com.
