Boonton, NJ (RPRN) 7/22/2009– The news is optimistic for breast cancer patients in cases where the ailment has spread to the bones. A clinical test shows that Denosumab is better than an existing drug on the market in treating the bone ailment affecting these patients.
Denosumab is a fully human monoclonal antibody that specifically targets the receptor activator of nuclear factor kappa B ligand (RANKL), a key mediator of the resorptive phase of bone remodeling. Denosumab is being studied across a range of conditions, including osteoporosis, treatment-induced bone loss, rheumatoid arthritis, bone metastases, and multiple myeloma.
A biologics license application (BLA) has recently been submitted to the U.S. Food and Drug Administration for Denosumab to be used in the treatment and prevention of postmenopausal osteoporosis in women and treatment and prevention of bone loss among patients undergoing hormone ablation for breast or prostate cancer.
Previous studies have suggested that Denosumab may be better than bisphosphonates in preventing bone loss and skeletal complications in women with breast cancer. To directly compare Denosumab to another injectable bisphosphonate product among breast cancer patients with bone metastases, researchers conducted a Phase III clinical trial. The study enrolled more than two thousand patients. Study participants were assigned to receive either of the two drugs. Although the results show that Denosumab may be better at preventing the spread of cancer to the bones, the frequency of a well-known bone side effect was similar.
â€œFor the millions of osteoporosis patients who are cancer-free and looking for convenient, safe alternatives to existing therapies, this product requires twice-yearly doctorsâ€™ visits for injection as compared to self-administered daily, weekly, or monthly pills or nasal sprays. Moreover, patients may suffer from the same type of side effect issues seen with some of the leading osteoporosis drugs,â€ warns bone expert Warren Levy, PhD, CEO of Unigene Laboratories.
Reports have associated certain bisphosphonates with osteonecrosis (i.e., â€œbone deathâ€) of the jaw, severe bone/joint pain, sudden fractures that do not heal, irregular heart rhythms, esophageal cancer, renal failure and potentially severe gastrointestinal side effects.
Alternative categories of drugs have been shown to reduce fracture risk including calcitonin, parathyroid hormone, estrogen, selective estrogen receptor modulators and testosterone.
â€œOther products have been shown to help certain osteoporosis patients maintain proper bone density without these potential risks,â€ says Dr. Levy. â€œDenosumab shows tremendous potential to help breast cancer patients, but for many osteoporosis patients, this new discovery may have both pros as cons.â€ For more information, log on to www.unigene.com
The Investor Relations Group