Tanezumab

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kevin
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Tanezumab

Post by kevin »

Tanezumab (experimental drug not yet FDA approved) has been mentioned on this forum a few times. Most recently, there was a study (see bottom) that showed that it reduced IC symptoms.

I read this article today:

http://www.technologyreview.com/biomedi ... 406/page1/
A new class of pain relievers that targets musculoskeletal pain receptors, instead of more general pain pathways, could alleviate osteoarthritis pain better than any drug now on the market, but hurdles remain before it's approved by the U.S. Food and Drug Administration. Research on the new therapy was published yesterday in the New England Journal of Medicine.
I did a bit more research on tanezumab.

Pfizer is recruiting for a new clinical study for tanezumab in IC: http://clinicaltrials.gov/ct2/show/stud ... how_locs=Y
They just finished a clinical study for tanezumab in CPPS: http://clinicaltrials.gov/ct2/show/stud ... how_locs=Y

Very interesting; I'll be keeping my eye on this medication, and would consider enrolling in a trial.

Here's the abstract that Webslave posted back in May:
Tanezumab Reduces Pain And Urgency In Interstitial Cystitis: Results Of A Phase 2 Trial

Robert Evans*,a, Robert Moldwinb, Nandini Cossonsc, Amanda Darekarc, David Scholfieldc, Ian Millsc

INTRODUCTION AND OBJECTIVES

Tanezumab, a humanized antibody specific for nerve growth factor, reduces pain in conditions such as osteoarthritis of the knee and low back pain. A phase 2 trial was performed to evaluate the safety and efficacy of tanezumab 200 ug/kg for the treatment of interstitial cystitis (IC).

METHODS

This was a randomized, double-blind, placebo-controlled study in patients with moderate to severe IC (O'Leary-Sant Interstitial Cystitis Symptom Index [ICSI] score of >=7 and Pelvic Pain and Urgency/Frequency [PUF] symptom score of >=13). After recording daily pain scores over 7 days and completing a daily urinary symptom diary for 3 of those days, patients with a mean pain intensity score of >=4 on an 11-point (0-10) Numeric Rating Scale (NRS) and a mean micturition frequency of >=8 per 24 hours, were randomized to receive a single dose of either tanezumab 200 ug/kg or placebo IV. During the 16 weeks post-treatment, patients attended 5 study visits (weeks 2, 4, 6, 10, 16). Patients were asked to record daily pain scores (using the 11-point NRS) for the 7 days prior to attending each study visit, and also to complete a daily urinary symptom diary for 3 of those days. The primary endpoint was change from baseline in average daily pain score at Week 6 as measured by the 11-point NRS. Secondary endpoints included changes in urgency episode frequency per 24 hours, micturition frequency per 24 hours, and mean voided volume (MVV) per micturition derived from the 3-day urinary symptom diary. Adverse events (AE) were monitored throughout the study.

RESULTS

Of the 65 patients enrolled in the study, 34 (91% female; mean age of 43.5 years) received tanezumab 200 ug/kg, 30 (87% female; mean age of 45.2 years) received placebo, and 1 patient did not receive treatment. At Week 6, tanezumab produced clinically significant improvements in average daily pain score and urgency episode frequency per 24 hours versus placebo, but had no clinically significant effect on micturition frequency per 24 hours or MVV per micturition versus placebo (Table 1). Overall, 47% of tanezumab patients and 40% of placebo patients had a treatment-related AE, the most common of which were paraesthesia (tanezumab: 15%; placebo 3%) and headache (12%; 7%).
tanezumab.gif
CONCLUSIONS

Tanezumab 200 ug/kg can effectively reduce both pain and urgency episode frequency in patients with IC and appears safe and well tolerated.

Source of Funding: Pfizer, Inc.
Started: Spring 2003; high urinary frequency and pain associated with bladder filling; urinary hesitancy; pubic/prostate/perineal discomfort; Helped by: trigger point therapy, Afrin nasal spray, Cymbalta, hydrocodone (small doses), distraction. Makes worse: sex.

Not medical advice. Consult your doctor.
gmccormack
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Re: Tanezumab

Post by gmccormack »

I was in this study, while I dont think it helped me, I spoke to others in the trial and some did in fact have a moderate to significant decrease in pain, one woman who was clearly in pain from IC/CPPS when she first started claimed she was pain free. I have my doubts but I can't argue with it.

What's frustrating is that Pfizer won't release if the patient was on the drug or placebo even after the trial has ended. I had absolutely zero side effects so I'm holding out some hope that I was given the placebo or a low dose.

I suspect this to be FDA approved for osteoarthritis by late 2011, then CPPS could use it off label. You will probably need to find a pain mngt center because this drug is IV or subcutaneous and I doubt your PCP would be familiar enough with it when its first approved especially for CPPS.

I love the mechanism of action with this, its makes complete sense, I think it could really help some men.
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kevin
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Re: Tanezumab

Post by kevin »

Here's a new article suggesting NGF (nerve growth factor) is correlated with CPPS symptoms. Tanezumab acts against NGF.

http://pubmed.ncbi.nlm.nih.gov/20883485
Started: Spring 2003; high urinary frequency and pain associated with bladder filling; urinary hesitancy; pubic/prostate/perineal discomfort; Helped by: trigger point therapy, Afrin nasal spray, Cymbalta, hydrocodone (small doses), distraction. Makes worse: sex.

Not medical advice. Consult your doctor.
kevin
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Re: Tanezumab

Post by kevin »

Update: The Tanezumab trial I linked to above has been suspended (along with many others). That seems unfortunate.
Started: Spring 2003; high urinary frequency and pain associated with bladder filling; urinary hesitancy; pubic/prostate/perineal discomfort; Helped by: trigger point therapy, Afrin nasal spray, Cymbalta, hydrocodone (small doses), distraction. Makes worse: sex.

Not medical advice. Consult your doctor.
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Re: Tanezumab

Post by webslave »

The worldwide suspension -- effective immediately -- is based on a small number of reports of patients treated with tanezumab who experienced worsening of their osteoarthritis to the point of requiring joint replacement.
http://osteoarthritis.about.com/b/2010/ ... pended.htm
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gmccormack
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Re: Tanezumab

Post by gmccormack »

This shocking, not only from a CPPS point of view but from an osteoarthritis point of view, this drug has helped many people obtain the unthinkable and I have seen it help CPPS/IC patients.

Being a cynic I wonder if it has to do with the fact that there were rumors out that it was too expensive to produce and therefore too expensive for the open market, insurance companies refused to cover and made it not economically feasible to continue. There are a number of other anti proteomic drugs coming out on the market in the next few years, lets see if they suffer the same fate.
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