By Andrea: http://nursingoncologyjob.com
Hologic, Inc. (HOLX), a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, announced that the Radiological Devices Panel (Panel) of the U.S. Food and Drug Administration (FDA) today unanimously voted that Hologic's Pre‐Market Approval (PMA) demonstrated both the effectiveness and safety of the Company's Selenia Dimensions three‐dimensional (3‐D) digital mammography tomosynthesis system, "Selenia Dimensions 3‐D." In addition, the Panel voted in favor that the benefits of this new technology outweigh the risks.
Following today's FDA Panel meeting, which was held in Gaithersburg, Maryland, Hologic will work with the FDA on next steps for approval of its 3‐D digital mammography system. While the Panel's favorable vote is advisory in nature, the FDA will consider it in its final review of Hologic's PMA application for the Selenia Dimensions tomosynthesis system.
"Our Selenia Dimensions 3‐D technology marks tremendous progress in the early diagnosis of breast cancer," said Jay A. Stein, Co‐Founder and Chief Technical Officer. "The system is designed to increase accuracy when screening women for the presence of cancerous tissue, and to enable a more precise characterization of suspicious lesions. I speak for all of Hologic in voicing great satisfaction that the FDA Panel has weighed in so positively in favor of this valuable new tool in the battle to limit breast cancer mortality."
Hologic's Selenia Dimensions 3‐D digital mammography tomosynthesis system is a new method for breast cancer screening and diagnosis. Unlike current mammography systems, which generate a two -dimensional (2‐D) image, breast tomosynthesis produces a three‐dimensional image. We believe our multicenter clinical study has demonstrated that compared to 2‐D digital mammography alone, 3‐D digital tomosynthesis used in combination with 2‐D digital mammography has the potential to reduce recall rates and improve cancer detection.
Hologic's Selenia Dimensions 3‐D digital mammography tomosynthesis system is presently commercially available outside the United States, including countries in Europe, Latin America and Asia. In North America, commercial systems are installed in Canada and Mexico. In the United States, Selenia Dimensions is currently available as a two dimensional only system that can be upgraded to do breast tomosynthesis (3‐D) imaging when and if the product is approved by the FDA.
"We are extremely pleased with the outcome of today's FDA Panel meeting," said Rob Cascella, President and Chief Executive Officer. "Hologic has worked diligently on the development of breast tomosynthesis to overcome the primary limitation of the existing 2‐D imaging technology, which is that the superimposition of normal breast anatomy may mask a breast cancer. Our Selenia Dimensions platform represents the next phase in breast cancer detection ‐ fast, high‐quality 2‐D and 3‐D digital tomosynthesis imaging of the breast. We look forward to working with the FDA to help complete the review process and bring this important new tool to radiologists to help save more women's lives."
Showing posts with label cancer discoveries. Show all posts
Showing posts with label cancer discoveries. Show all posts
Saturday, October 16, 2010
Molecular Insight Pharmaceuticals: Prostate Cancer Update
By Andrea: http://nursingoncologyjob.com
Molecular Insight Pharmaceuticals, Inc.(MIPI) this week presented positive data from Phase 1 clinical studies comparing Trofex(TM) (123I-MIP-1072), its lead molecular imaging candidate for the diagnosis and monitoring of metastatic prostate cancer, and ProstaScint(R) (111In-capromab pendetide), an imaging radiopharmaceutical for the visualization of metastatic prostate cancer. Data presented at the Annual Congress of the European Association of Nuclear Medicine in Vienna demonstrated that Trofex rapidly detected prostate cancer localized in the prostate bed, soft tissues and bone within four hours post injection. In contrast, ProstaScint required five days before imaging and was unable to detect metastatic disease in bone.
Trofex is a radiolabeled, small-molecule that binds prostate specific membrane antigen (PSMA), a protein highly expressed by prostate cancer cells, with high affinity and specificity. The high degree of uptake and retention of Trofex in prostate cancer cells allows for non-invasive molecular imaging of prostate cancer.
Data from two completed Phase 1 studies and preliminary data from one ongoing Phase 1 study were presented in an abstract titled: Detection of Metastatic Prostate Cancer (PCa) in Soft Tissue, Bone, and Prostate with 123I-MIP-1072: A Comparison with 111In-Capromab Pendetide. John W. Babich, Ph.D., Molecular Insight Executive Vice President, Chief Scientific Officer and President of Research and Development, senior author of the study, presented the data from these studies.
Study Methodology The two completed Phase 1 studies enrolled a total of 13 subjects (7 prostate cancer patients and 6 healthy volunteers) while in the ongoing study 12 patients have been enrolled. In the first two studies, patients with confirmed metastatic prostate cancer and normal subjects received Trofex (370 MBq), followed by serial whole-body planar imaging, SPECT/CT scanning, and blood and urine analysis. Image analysis from the Trofex scans was used to estimate organ pharmacokinetics and to calculate radiation dosimetry. In the ongoing study, Trofex and ProstaScint images as well as bone scans were compared in the same patient. All images were compared visually and by quantitative image analysis for assessing relative tumor detectability.
Conclusions Molecular Insight reported that in this limited group of patients Trofex visualized lesions in the prostate, lymph nodes and bone at four hours after injection, confirming that targeting the extracellular domain of PSMA with small molecules is a viable approach for imaging metastatic prostate cancer. In comparison to Trofex, which is rapidly cleared from the blood and can detect tumors within a few hours, ProstaScint requires five days for optimal imaging. In this study, ProstaScint was unable to detect bone metastases and required supplementary blood pool imaging for confirmation of lymph node metastases along the normal vasculature.
In the second presentation at the EANM Annual Congress, Molecular Insight reported new preclinical data from its prostate cancer therapy program. Molecular Insight scientists have developed an analog of Trofex that carries the therapeutic iodine radionuclide, I-131, creating a molecularly targeted radiotherapeutic that specifically binds PSMA on prostate cancer cells and offers the potential for treatment of metastatic prostate cancer. In an abstract titled Inhibition of Human Prostate Cancer Growth by Targeting Prostate Specific Membrane Antigen (PSMA) using an I-131 labeled small molecule inhibitor, researchers reported that a Molecular Insight compound, 131I-MIP-1375, was effective at inhibiting, in a dose-related manner, the growth of human PSMA-expressing prostate tumors in a mouse model. The Company said that these preclinical data provide a basis for advancing the development of 131I-MIP-1375 as a targeted radiotherapeutic option in the treatment of prostate cancer.
About Prostate Cancer According to the American Cancer Society, more than 2.5 million men are currently affected by prostate cancer and approximately 200,000 new cases are diagnosed annually. While early diagnosis has improved overall survival rates, prostate cancer is the second leading cause of cancer death among men in the United States. Most prostate cancer mortalities occur when the disease has spread and therefore staging and monitoring the disease accurately is critically important in improving patient outcomes.
Molecular Insight Pharmaceuticals, Inc.(MIPI) this week presented positive data from Phase 1 clinical studies comparing Trofex(TM) (123I-MIP-1072), its lead molecular imaging candidate for the diagnosis and monitoring of metastatic prostate cancer, and ProstaScint(R) (111In-capromab pendetide), an imaging radiopharmaceutical for the visualization of metastatic prostate cancer. Data presented at the Annual Congress of the European Association of Nuclear Medicine in Vienna demonstrated that Trofex rapidly detected prostate cancer localized in the prostate bed, soft tissues and bone within four hours post injection. In contrast, ProstaScint required five days before imaging and was unable to detect metastatic disease in bone.
Trofex is a radiolabeled, small-molecule that binds prostate specific membrane antigen (PSMA), a protein highly expressed by prostate cancer cells, with high affinity and specificity. The high degree of uptake and retention of Trofex in prostate cancer cells allows for non-invasive molecular imaging of prostate cancer.
Data from two completed Phase 1 studies and preliminary data from one ongoing Phase 1 study were presented in an abstract titled: Detection of Metastatic Prostate Cancer (PCa) in Soft Tissue, Bone, and Prostate with 123I-MIP-1072: A Comparison with 111In-Capromab Pendetide. John W. Babich, Ph.D., Molecular Insight Executive Vice President, Chief Scientific Officer and President of Research and Development, senior author of the study, presented the data from these studies.
Study Methodology The two completed Phase 1 studies enrolled a total of 13 subjects (7 prostate cancer patients and 6 healthy volunteers) while in the ongoing study 12 patients have been enrolled. In the first two studies, patients with confirmed metastatic prostate cancer and normal subjects received Trofex (370 MBq), followed by serial whole-body planar imaging, SPECT/CT scanning, and blood and urine analysis. Image analysis from the Trofex scans was used to estimate organ pharmacokinetics and to calculate radiation dosimetry. In the ongoing study, Trofex and ProstaScint images as well as bone scans were compared in the same patient. All images were compared visually and by quantitative image analysis for assessing relative tumor detectability.
Conclusions Molecular Insight reported that in this limited group of patients Trofex visualized lesions in the prostate, lymph nodes and bone at four hours after injection, confirming that targeting the extracellular domain of PSMA with small molecules is a viable approach for imaging metastatic prostate cancer. In comparison to Trofex, which is rapidly cleared from the blood and can detect tumors within a few hours, ProstaScint requires five days for optimal imaging. In this study, ProstaScint was unable to detect bone metastases and required supplementary blood pool imaging for confirmation of lymph node metastases along the normal vasculature.
In the second presentation at the EANM Annual Congress, Molecular Insight reported new preclinical data from its prostate cancer therapy program. Molecular Insight scientists have developed an analog of Trofex that carries the therapeutic iodine radionuclide, I-131, creating a molecularly targeted radiotherapeutic that specifically binds PSMA on prostate cancer cells and offers the potential for treatment of metastatic prostate cancer. In an abstract titled Inhibition of Human Prostate Cancer Growth by Targeting Prostate Specific Membrane Antigen (PSMA) using an I-131 labeled small molecule inhibitor, researchers reported that a Molecular Insight compound, 131I-MIP-1375, was effective at inhibiting, in a dose-related manner, the growth of human PSMA-expressing prostate tumors in a mouse model. The Company said that these preclinical data provide a basis for advancing the development of 131I-MIP-1375 as a targeted radiotherapeutic option in the treatment of prostate cancer.
About Prostate Cancer According to the American Cancer Society, more than 2.5 million men are currently affected by prostate cancer and approximately 200,000 new cases are diagnosed annually. While early diagnosis has improved overall survival rates, prostate cancer is the second leading cause of cancer death among men in the United States. Most prostate cancer mortalities occur when the disease has spread and therefore staging and monitoring the disease accurately is critically important in improving patient outcomes.
Neogenix Oncology: Pancreatic and Colocrectal Cancer Update
By Andrea: http://nursingoncologyjob.com
Neogenix Oncology, Inc. recently announced that it will present data from its new serum biomarker ELISA utilizing its NPC-1C antibody for patients with colorectal and pancreatic cancers. Results from the study will be presented at the American Society of Clinical Oncology (ASCO)-NCI-EORTC Annual Meeting on Molecular Makers in Cancer, to be held in Hollywood, Florida from October 18-20, 2010.
Neogenix has developed an ELISA serum biomarker using, NPC-1C, its novel, proprietary chimeric antibody that selectively targets pancreatic and colorectal cancer. The prospective study, being conducted at Conemaugh Cancer Center, in Johnstown, PA, provides for the evaluation of blood serum samples from patients confirmed with pancreatic or colon cancer. Preliminary results demonstrate the Neogenix biomarker assay’s ability to differentiate between blood serum of healthy donors and that of patients with colorectal or pancreatic cancer. In addition, the results of the NPC-1C biomarker test indicate superior sensitivity as compared to commercially available CEA and CA19-9 assays. A complete data set will be presented at the ASCO Meeting.
"We are very excited about the study results which hold promise for the early detection of these devastating diseases. These tests could provide a real hope for patients by enabling early intervention and substantially improved clinical outcome,” says Philip M. Arlen, M.D, President and CEO of Neogenix Oncology.
Neogenix Oncology, Inc. recently announced that it will present data from its new serum biomarker ELISA utilizing its NPC-1C antibody for patients with colorectal and pancreatic cancers. Results from the study will be presented at the American Society of Clinical Oncology (ASCO)-NCI-EORTC Annual Meeting on Molecular Makers in Cancer, to be held in Hollywood, Florida from October 18-20, 2010.
Neogenix has developed an ELISA serum biomarker using, NPC-1C, its novel, proprietary chimeric antibody that selectively targets pancreatic and colorectal cancer. The prospective study, being conducted at Conemaugh Cancer Center, in Johnstown, PA, provides for the evaluation of blood serum samples from patients confirmed with pancreatic or colon cancer. Preliminary results demonstrate the Neogenix biomarker assay’s ability to differentiate between blood serum of healthy donors and that of patients with colorectal or pancreatic cancer. In addition, the results of the NPC-1C biomarker test indicate superior sensitivity as compared to commercially available CEA and CA19-9 assays. A complete data set will be presented at the ASCO Meeting.
"We are very excited about the study results which hold promise for the early detection of these devastating diseases. These tests could provide a real hope for patients by enabling early intervention and substantially improved clinical outcome,” says Philip M. Arlen, M.D, President and CEO of Neogenix Oncology.
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