|Exact Sciences Publish Results of DeeP-C Study in NEJM; Navidea Offers Update on EMA Application For Lymphoseek|
|By Staff and Wire Reports|
|Wednesday, 19 March 2014 18:54|
Exact Sciences Corp. (Nasdaq: EXAS) announced results from its DeeP-C pivotal clinical study have been published online in the New England Journal of Medicine. The peer-reviewed study, “Multi-target Stool DNA Testing for Colorectal-Cancer Screening” will also appear in the journal's April 3, 2014 print issue.
The 10,000-patient DeeP-C study was designed to determine the performance characteristics of Exact Sciences' multi-target stool DNA-based screening test, Cologuard ®, for colorectal cancer and to compare that performance to the fecal immunochemical test (FIT), a commonly used non-invasive colorectal cancer screening test. The DeeP-C study took place at 90 centers throughout the U.S. and Canada.
The DeeP-C data published in the NEJM elaborate on top-line data Exact Sciences announced in April of 2013. Data published today include:
* Sensitivity of Cologuard in detecting patients with colorectal cancer was 92% versus 74% for FIT; * Sensitivity in detecting patients with colorectal cancers in Stages I-III —those determined by the American Joint Committee on Cancer to be associated with an increased rate of being cured—was 93% for Cologuard versus 73 % for FIT; * Sensitivity for patients with advanced pre-cancerous lesions was 42% for Cologuard versus 24% for FIT; * Cologuard detected 69% of patients with polyps with high-grade dysplasia versus 46% for FIT; * Cologuard achieved a specificity of 87% versus FIT specificity of 95%.
Colorectal cancer is often considered the most preventable, yet least prevented cancer. One out of 3 adults age 50 and older has not been screened as recommended and, as a result, colorectal cancer remains the second-leading cancer killer in the United States. Colorectal cancer is highly treatable if found early, making the detection of pre-cancerous polyps paramount.
“We know that colorectal cancer can be prevented and can be highly treatable if found early through screening,” said lead author Thomas F. Imperiale M.D., of the Indiana University School of Medicine, Regenstrief Institute Inc., the IU Simon Cancer Center, and the Roudebush VA Medical Center in Indianapolis. “Sensitivity is the most important characteristic for screening tests because the primary role of such testing is to rule out diseases such as cancer. In our clinical study, the data show that Cologuard, the multi-target stool-based DNA test, is highly sensitive in detecting colorectal cancer and higher risk pre-cancerous polyps in a large, diverse average-risk patient population and has the potential to be an important screening tool.”
“We are very pleased with the data published today in the New England Journal of Medicine,” said Kevin T. Conroy, president and chief executive of Exact Sciences. “We believe Cologuard could be an important tool in the early detection of colorectal cancer. This is an important milestone for Exact Sciences and Cologuard.”
The Exact Sciences Cologuard screening test is an investigational device currently under review by the U.S. Food and Drug Administration (FDA) and is not available for sale in the United States. The FDA's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is scheduled to review Exact Science's PMA application for Cologuard on March 27, 2014.
Navidea Biopharmaceuticals, Inc. (NYSE: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced it held an update meeting with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the pending Marketing Authorization Application (MAA) of Lymphoseek^® (technetium Tc 99m tilmanocept) Injection. Lymphoseek is a lymphatic mapping agent designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. As part of the MAA review process, Navidea presented Oral Explanations to the CHMP relating to open questions in the Lymphoseek MAA. At the conclusion of the meeting, the CHMP informed Navidea that the Committee will continue with its review of the MAA. Navidea believes the course of the review continues to be supportive of its market development plans and outlook for material revenue generation in Europe beginning in 2015, as previously disclosed.
Based on feedback received at the meeting, Navidea believes that the CHMP has found the safety and efficacy data submitted in the MAA for breast cancer and melanoma to be acceptable. The CHMP will now focus its review on the remaining areas of product specifications unique to the European application and on data from the Phase 3 study in head and neck cancer. During this process, the MAA remains active but the review clock will continue to be stopped while Navidea works with the CHMP to address these remaining areas.
"The European review of Lymphoseek continues to progress. The Oral Explanation meeting was productive and provided an opportunity for both Navidea and our technical experts to discuss the Lymphoseek application with the CHMP. We achieved our goals in this meeting of getting positive feedback on the breast cancer and melanoma aspects of the filing and clarifying the remaining areas of focus so the review can proceed in a timely manner. We appreciate the CHMP's constructive input and guidance,” stated Mark Pykett, VMD, PhD, Navidea CEO. “We will continue our ongoing dialogue with the EMA to address remaining areas and plan to provide further updates on this process in the coming weeks.”
The Lymphoseek MAA is supported by a comprehensive, multi-trial clinical program including two Phase 3 studies of Lymphoseek (NEO3-05 and NEO3-09) performed in patients with either breast cancer or melanoma and a third Phase 3 study (NEO3-06), in patients with head and neck cancer, contributing to a safety database of more than 550 patients. The MAA is based on the same pivotal efficacy and safety data package provided in the U.S. New Drug Application (NDA) and two supplemental NDA (sNDA) submissions. The U.S. Food and Drug Administration (FDA) approved Lymphoseek in the United States in 2013 for use in lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma. Lymphoseek was also granted Fast Track designation and Priority Review for one of its sNDAs focused on sentinel lymph node detection in patients with head and neck cancer, with an upcoming Prescription Drug User Fee Act (PDUFA) target date of June 16, 2014. The second sNDA has a PDUFA target date of October 16, 2014.
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Cutting edge and industry leading YouTube based talk show "Getting Doug with High" will feature the products and services of title sponsors SK3 Group (OTC Pink: SKTO) (PINKSHEETS: SKTO) and Pharmajanes.com (OTCQB: AEGY) (PINKSHEETS: AEGY) ( later today at 6:15pm Pacific Time.
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