Navidea Biopharmaceuticals, Inc Joins Rheumco, LLC to Develop Radiopharmaceuticals for Detection and Treatment of Arthritic Diseases
Jul 16 14
Navidea Biopharmaceuticals Inc. announced that it has formed a joint enterprise with Rheumco, LLC, to develop and commercialize radiolabeled diagnostics and therapeutics for rheumatologic and arthritic diseases. The joint enterprise, called R-NAV, LLC, will combine Navidea's proprietary Manocept CD206 macrophage targeting platform and Rheumco's proprietary Tin-117m radioisotope technology to focus on leveraging the platforms across several indications with high unmet medical need: Detection of rheumatoid arthritis (RA) initially using Tc-99m tilmanocept, commercially known as Lymphoseek(R) (technetium Tc-99m tilmanocept) Injection, Combination of the Manocept platform with Tin-117m for detection and treatment of RA, Detection and treatment of human and veterinary osteoarthritis (OA) using the Tin-117m technology, and Treatment of pediatric hemophilic arthropathy (PHA); a rare rheumatologic condition. R-NAV will focus on deploying the two technology platforms as an ideal combination for the development of novel diagnostic and therapeutic agents for rheumatologic and arthritic conditions. For a number of years, Essex Woodlands and Rheumco have invested in the development of their patented, high-specific-activity Tin-117m technology to optimize its therapeutic potential and safety profile. Tin-117m possesses unique imaging and therapeutic properties not found in alternative medical isotopes, including its ability to locally target disease-causing cells without damaging adjacent healthy tissue. Navidea's Manocept technology is able to quickly seek out and attach to certain immune cells expressing CD206, called macrophages. Macrophages are an emerging participant in disease-associated inflammation, which has been found to play a role in conditions such as RA, cancer, and heart disease. R-NAV will be initially funded primarily through a $4 million investment from Infinity Capital III, of Houston-based McRay Money Management, and other third-party private investors working closely with Essex Woodlands, and underpinning the technology contributions from Rheumco and Navidea. Navidea has committed an additional $1 million to support R-NAV's development efforts to be paid in equal installments over three years. In exchange for its cash, in-kind and technology contributions, Navidea has received both common units and Preferred Series A units of R-NAV and will initially own approximately 30% of the combined entity. Joint oversight of R-NAV is shared between Navidea, Rheumco, Infinity Capital III of Houston-based McRay Money Management, and the other investors. Navidea also has an option to acquire, at its sole discretion prior to Phase 3 clinical study, imaging products derived from the Manocept platform, and therapeutic products combining Manocept agents from Navidea with the Tin-117m technology for commercialization. Detection of RA, a chronic, progressive, systemic autoimmune disorder, is the nearest-term opportunity being pursued by R-NAV. Clinicians are often faced with diagnostic confusion early in disease progression resulting in inaccurate diagnosis when existing therapies could be most effective. There is currently no approach to reliably detect, evaluate or therapeutically target the macrophage inflammatory component of RA, which is a key driver of RA pathogenesis. Misdiagnosis results in billions of dollars being spent each year unnecessarily on therapies, which may result in significant side effects. According to the Centers for Disease Control (CDC), the overall cost of arthritis and other rheumatic conditions in the U.S. was approximately $128 billion in 2003. Of this, $80.8 billion was due to direct costs and $47 billion was due to indirect costs (lost wages only). The CDC also notes that in 2004 arthritis resulted in 78 million physician visits and 5 million hospitalizations having a principal or secondary diagnosis of arthritis. Further, current intervention using methotrexate or biologics is costly, associated with side effects, and in many cases does not adequately treat the disease or the underlying inflammatory pathology. A targeted imaging agent such as Manocept could assist physicians and healthcare providers to better diagnose patients and allow for earlier and more effective intervention, and use of a Tin-117m therapeutic could improve and localize therapeutic intervention for the same patients.
Navidea Announces Positive Results from Phase III Solid Tumor Analyses
Jun 27 14
Navidea Biopharmaceuticals Inc. has announced positive results from combined analyses of Phase III clinical trials that evaluated Lymphoseek efficacy in lymphatic mapping for identifying pathology-positive lymph nodes across multiple solid tumor types including melanoma, breast cancer and head and neck squamous cell carcinoma. The results indicated that Lymphoseek sensitivity for sentinel lymph node mapping was consistent across the tumor type studies, regardless of whether surgery was conducted on the same day as, or on the day after injection of Lymphoseek. Additionally, for patients with head and neck cancer, Lymphoseek demonstrated a low false negative rate (FNR) of 2.6% (4.6% for same day injection before surgery and 0.0% FNR in patients injected the day prior to surgery). Results from this study are also included in a second sNDA for Lymphoseek label expansion currently in review with the FDA, which is designed to support more flexible utilization of Lymphoseek in lymphatic mapping and lymphoscintigraphy imaging. These applications reflect Navidea's commitment to expanding usage and indications for Lymphoseek and belief that the product can provide a flexible, reliable and cost-effective solution for lymphatic mapping across a wide range of tumor types." The study evaluated Lymphoseek sensitivity in 384 evaluable patients from three pivotal Phase III clinical studies: two Phase III studies in patients with breast cancer and melanoma (melanoma, n=153; breast cancer, n=148) and one Phase III study in patients with head and neck squamous cell carcinoma (n=83). Patients were injected before surgery, imaged, and then surgery was conducted up to 30 hours post-injection. Results based on sensitivity for day-of-injection or day-after-injection were compared. Meta-analysis results across tumor types (n=100 pathology-positive patients) indicated per patient sensitivity for Lymphoseek in identifying pathology-positive subjects. Sensitivity for Lymphoseek was 99% in same day injection procedures, and 99% in surgery procedures performed the day after injection. In addition, the FNR for patients with head and neck squamous cell carcinoma was 4.6% (95% CI: 0.1%-22.8%) for same day injection (n=40) and 0.000 (95% CI: 0%-20.6%) for patients who had surgery on the day after injection (n=42).
Navidea Biopharmaceuticals, Inc - Special Call
Jun 16 14
To discuss the role of sentinel lymph node biopsy in head and neck cancers