|Results of Lymphoseek Phase 3 Clinical Trials Published; Anacor Announces Positive Results From Phase 2 Study of AN2728|
|By Staff and Wire Reports|
|Thursday, 21 March 2013 18:50|
Navidea Biopharmaceuticals (NYSE: NAVB), a biopharmaceutical company focused on the development and commercialization of precision diagnostic radiopharmaceuticals, announced the peer-reviewed publication of results from two Phase 3 clinical trials of Lymphoseek® (technetium 99m tilmanocept) Injection in patients with breast cancer. The trials assessed the performance of Lymphoseek against the standard of care, vital blue dye (VBD), in lymphatic mapping. Results demonstrated that Lymphoseek met its primary efficacy endpoint of rate of agreement, or concordance, with VBD. The study, “Comparative Evaluation of [99mTc]Tilmanocept for Sentinel Lymph Node Mapping in Breast Cancer Patients: Results of Two Phase 3 Trials,” was published in the current online edition of the journal Annals of Surgical Oncology [DOI 10.1245/s10434-013-2887-8].
Lymphoseek is a receptor-targeted radiopharmaceutical recently approved by the U.S. Food and Drug Administration and indicated for use in lymphatic mapping for breast cancer and melanoma. In this procedure key lymph nodes adjacent to a primary tumor, that may contain tumor metastases, are identified and biopsied to determine if cancer has spread to these lymph nodes.
“Lymphoseek was specifically designed to provide clinicians who perform lymphatic mapping procedures with actionable information, and we believe that the data reported in this publication demonstrate its utility and safety in identifying tumor-draining lymph nodes,” said Frederick Cope, Ph.D., Senior Vice President, Pharmaceutical Research and Clinical Development of Navidea. “These data from breast cancer patients, in conjunction with previously published data from our Phase 3 clinical trials in melanoma, comprise part of our NDA registration package for Lymphoseek with the FDA. We are confident that Lymphoseek may hold significant improvement for patients who undergo lymphatic mapping procedures.”
“Tilmanocept was originally developed at UCSD as a targeted molecular approach to help stage breast cancer and melanoma patients, and we advanced the agent through Phase 1 clinical trials with funding provided by Susan G. Komen Breast Cancer Foundation and the American Cancer Society," said Anne Wallace, M.D., Chief, Division of Plastic Surgery; Professor of Surgery, UC San Diego School of Medicine; Director of the Breast Care Unit; UC San Diego Moores Cancer Center; and a Principal Investigator in the Lymphoseek Phase 3 clinical trials. “The results from these Phase 3 clinical trials in breast cancer demonstrate the potential that specifically-designed imaging agents may have an important role in reliably localizing tumor-draining lymph nodes and in optimizing patient management post-surgery. Appropriate lymphatic mapping and sentinel node biopsy can benefit certain patients by sparing them removal of unnecessary lymphoid tissue and preventing side effects such as lymphedema or swelling, pain and sensory changes, scarring or disfigurement, and extended recovery times.”
Completed Lymphoseek Phase 3 Clinical Trials in Breast Cancer -- Two Phase 3 non-randomized trials were conducted in patients with breast cancer undergoing lymphatic mapping. The primary endpoint was the rate of agreement (concordance) between [99mTc]tilmanocept and vital blue dye, which was defined as the proportion of lymph nodes identified by VBD that were also identified by Lymphoseek. A pre-specified minimum rate of agreement of 90% had been established in the trials' statistical plan. In the trials, a total of 148 patients with breast cancer from 13 centers received [99mTc]tilmanocept followed by vital blue dye and then underwent sentinel lymph node mapping. Lymph nodes that demonstrated [99mTc]tilmanocept uptake and/or the presence of blue dye were removed and examined for the presence of tumor. Of the 209 blue-dyed lymph nodes removed from the patients, 207 (99.04%) demonstrated [99mTc]tilmanocept uptake (p<0.0001).
In assessing reverse concordance (the proportion of blue-dyed nodes relative to all nodes with [99mTc]tilmanocept uptake) according to the protocol, Lymphoseek detected 320 lymph nodes. Of these nodes, VBD detected 207 (64.69%).
Anacor Pharmaceuticals (NASDAQ:ANAC) announced positive results from a Phase 2 dose-ranging trial (AN2728-AD-204) of its topical boron-based phosphodiesterase-4 (PDE-4) inhibitor, AN2728. The study included 86 adolescents (ages 12 17) with mild-to-moderate atopic dermatitis, a chronic rash which predominantly affects children and is characterized by inflammation and itching. In this study, lesions treated with AN2728 ointment, 2.0% twice daily for 28 days achieved a 71% improvement from baseline in their Atopic Dermatitis Severity Index (ADSI) score, with 66% of lesions in this treatment group achieving total or partial clearance. AN2728 was generally safe and well-tolerated. Most adverse events were mild and largely unrelated to study drug.
These results demonstrate a clear dose response across the four dosing regimens and identify the AN2728 ointment, 2.0% BID dosing regimen as optimal for a Phase 3 program, which we expect to initiate around the end of 2013, said David Perry, Chief Executive Officer of Anacor Pharmaceuticals. In all arms of the study, lesions treated with AN2728 ointment improved throughout the 28 day treatment period. The majority of the improvement occurred within the first week of treatment, which is important to both patients and physicians. AN2728 also continues to demonstrate an excellent safety profile - a key factor in treating this disease that primarily affects children.
There is a tremendous clinical need for safe and effective treatments for pediatric atopic dermatitis. It is very exciting to see these promising positive data for a novel molecule with excellent anti-inflammatory properties and that appears very safe to use, said Lawrence F. Eichenfield, M.D., Chief of Pediatric and Adolescent Dermatology and Professor of Pediatrics and Medicine (Dermatology) at Rady Children's Hospital, University of California, San Diego. AN2728 has the potential to be an outstanding addition to the treatment armamentarium for physicians and a great benefit to children with atopic dermatitis.
The Phase 2 randomized, double-blind, bilateral study enrolled adolescent patients with mild-to-moderate atopic dermatitis. Patients were randomized 1:1 to either once daily (QD) or twice daily (BID) application for 28 days. Patients were instructed to apply AN2728 ointment, 2.0% to one target lesion and AN2728 ointment, 0.5% to a comparable target lesion. The primary endpoint was the change from baseline ADSI score, which is the sum of the severity scores of five clinical features (erythema, pruritus, exudation, excoriation and lichenification) from 0 (none) to 3 (severe) for each feature, for a total score of 0 to 15. Additional endpoints included differences in ADSI component subscores and safety.
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Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on the development and commercialization of precision diagnostic radiopharmaceuticals, today announced the peer-reviewed publication of results from two Phase 3 clinical trials of Lymphoseek® (technetium 99m tilmanocept) Injection in patients with breast cancer.
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