Tanezumab
Tanezumab (INN, codenamed RN624) is a monoclonal antibody against nerve growth factor as a treatment for pain. Tanezumab was discovered and developed by Rinat Neuroscience[1] and was acquired by Pfizer in 2006.
Monoclonal antibody | |
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Type | Whole antibody |
Source | Humanized (from mouse) |
Target | NGF |
Clinical data | |
Other names | RN624 |
ATC code |
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Identifiers | |
CAS Number | |
ChemSpider |
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UNII | |
Chemical and physical data | |
Formula | C6464H9942N1706O2026S46 |
Molar mass | 145445.32 g·mol−1 |
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In 2009 there was a Phase III trial for knee pain due to osteoarthritis (OA).[2] Another Phase III trial for hip pain in OA[3] was halted in June 2010 when some patients needed hip replacement.[4]
Tanezumab is undergoing Phase II clinical trials for the treatment of various pain entities, including chronic low back pain, bone cancer pain, and interstitial cystitis.[5]
In March 2012, the Anti-NGF Testing - FDA Committee voted in favor of a continuation of the development of nerve-blocking medications, as long as certain safety precautions were observed.[6][7]
A Phase III trial published in 2013 found tanezumab was superior to placebo for painful hip osteoarthritis.[8]
At February 19, 2019 the co-development partners - Eli Lilly and Pfizer - announced that treatment with tanezumab 10 mg met the primary endpoint, demonstrating a statistically significant improvement in chronic low back pain at 16 weeks compared to placebo (however, 5 mg arm demonstrated a numerical improvement in pain, but did not reach statistical significance compared to placebo at the week 16 analysis).[9]
See also
References
- Shelton DL, Zeller J, Ho WH, Pons J, Rosenthal A (July 2005). "Nerve growth factor mediates hyperalgesia and cachexia in auto-immune arthritis". Pain. 116 (1–2): 8–16. doi:10.1016/j.pain.2005.03.039. PMID 15927377. S2CID 36145654.
- Clinical trial number NCT00733902 for "Tanezumab in Osteoarthritis of the Knee" at ClinicalTrials.gov
- Clinical trial number NCT00744471 for "Tanezumab in Osteoarthritis Of The Hip" at ClinicalTrials.gov
- "Trials Halted as Pfizer's Tanezumab Shown to Worsen Osteoarthritis". Genetic Engineering & Biotechnology News. 24 June 2010. Archived from the original on 23 January 2013.
- "Phase II trials involving Tanezumab". ClinicalTrials.gov. U.S. National Library of Medicine.
- "Tanezumab Arthritis Advisory Committee Briefing Document" (PDF). US Food and Drug Administration. 8 February 2012. Archived from the original (PDF) on 19 January 2017.
- Verburg K. "Monoclonal Antibodies Targeted Against Nerve Growth Factor For the Treatment of Chronic Pain" (PDF). Medicines Development Group, Pfizer Inc. Archived from the original (PDF) on 9 May 2017.
- Brown MT, Murphy FT, Radin DM, Davignon I, Smith MD, West CR (July 2013). "Tanezumab reduces osteoarthritic hip pain: results of a randomized, double-blind, placebo-controlled phase III trial". Arthritis and Rheumatism. 65 (7): 1795–803. doi:10.1002/art.37950. PMID 23553790.
- "Pfizer and Lilly Announce Top-line Results From Phase 3 Study of Tanezumab in Chronic Low Back Pain". Seeking Alpha. PR Newswire. February 19, 2019.