New study starting (now cancelled)

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dshoskes
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New study starting (now cancelled)

Post by dshoskes »

Update: study cancelled

Aquinox Pharmaceuticals Announces Initiation of ProShip Phase 2 Proof-of-Concept Clinical Trial Investigating Rosiptor in CP/CPPS

Trial Will Enroll Approximately 100 Male Subjects in the US and Canada -

VANCOUVER, British Columbia, June 11, 2018 (GLOBE NEWSWIRE) -- Aquinox Pharmaceuticals, Inc. ("Aquinox") (NASDAQ:AQXP), a clinical-stage pharmaceutical company discovering and developing novel drug candidates to treat inflammation, inflammatory pain, and blood cancers, today announced initiation of dosing in ProShip, a Phase 2 proof-of-concept clinical trial evaluating the efficacy and safety of once-daily rosiptor in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), a urological condition characterized by chronic pelvic pain and voiding symptoms without evidence of urinary tract infection. There are currently no FDA approved treatment options for CP/CPPS.

The 12-week, randomized, double-blind, placebo-controlled ProShip clinical trial will evaluate rosiptor 200 mg versus placebo (randomized in a 1:1 ratio) in approximately 100 male subjects with CP/CPPS. The primary endpoint is the change in maximum daily pelvic pain from baseline to Week 12 versus placebo using an 11-point numeric rating scale. Secondary endpoints include relevant Patient Reported Outcomes (PROs) measuring pain, urinary frequency, and sexual dysfunction.

“Inflammation is believed to play a key role in CP/CPPS, supporting the evaluation of rosiptor for the treatment of this condition,” said Barbara Troupin, MD, MBA, Chief Medical Officer and Vice President of Clinical Development & Regulatory Affairs of Aquinox. “The design of ProShip builds on the learnings from our ongoing clinical trial program with rosiptor in interstitial cystitis/bladder pain syndrome (IC/BPS), another urological condition with significant unmet need defined by chronic pain and urinary symptoms.”

About Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
CP/CPPS is a urological condition characterized by chronic pelvic pain and voiding symptoms without evidence of urinary tract infection. Symptoms may include pelvic pain, urinary symptoms, and sexual dysfunction. Estimates suggest up to 5M males in the United States have symptoms of CP/CPPS yet only about 1M of these patients are diagnosed and treated. There are currently no FDA approved and/or effective treatment options for CP/CPPS, and few treatments in development.

About Aquinox Pharmaceuticals, Inc.
Aquinox Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company developing novel therapeutics for chronic urological conditions marked by inflammation and pain. Aquinox's lead drug candidate, rosiptor (AQX-1125), is in Phase 3 development for the treatment of patients with interstitial cystitis/bladder pain syndrome (IC/BPS) and in a Phase 2 trial for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), debilitating conditions marked by chronic pain and urinary symptoms, for which there are currently few FDA approved and/or effective treatment options. Aquinox is focused on leveraging its library of novel compounds that activate SHIP1 to develop therapeutics for application in inflammation, inflammatory pain, and blood cancers. For more information, please visit www.aqxpharma.com.


Full disclosure: I'm the national PI for the study and have been paid by the company to assist them in its design and execution.
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Re: New study starting

Post by ChgoGuy »

Thanks for the info. I enrolled and will see if I am accepted into the study.
Age: 52 | Onset Age:49 (but I may have had warning signs 25 yrs earlier)| Symptoms: Pretty much all the usual suspects. Frequency, urgency, inability to always empty, burning and numbing uretheral, penile & perineum pain. Frequent urination at night.| Helped By: Internal PT. Myrbetriq helps but is by no means great. TENS to help sleep, and hand held massages of the lower back, hips and buttocks. Standing and physical labor help. Stretches and hot baths. Occasionally use gel iced pad on the perineum. Worsened By: Sitting (being sedentary), driving, sex, bowel movements, tight clothing and underwear. | Other comments: Currently trying L-Theanine
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Re: New study starting

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Re: New study starting

Post by ChgoGuy »

I spoke to somebody today, and although I would make a good candidate for the study, I'm too far from the research sites.

Damn!
Age: 52 | Onset Age:49 (but I may have had warning signs 25 yrs earlier)| Symptoms: Pretty much all the usual suspects. Frequency, urgency, inability to always empty, burning and numbing uretheral, penile & perineum pain. Frequent urination at night.| Helped By: Internal PT. Myrbetriq helps but is by no means great. TENS to help sleep, and hand held massages of the lower back, hips and buttocks. Standing and physical labor help. Stretches and hot baths. Occasionally use gel iced pad on the perineum. Worsened By: Sitting (being sedentary), driving, sex, bowel movements, tight clothing and underwear. | Other comments: Currently trying L-Theanine
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Re: New study starting

Post by HateCPPS »

I somewhat believe that inflammation is the main reason of my problem, and that the muscular aspect is secondary, so this is exciting.

Curious of how taking this drug for 12 weeks would differ from taking steroids or heavy doses of NSAIDs? Do we believe this has a large upside over those therapies? This SHIP1 drug seems to be in a different class of sort of uncharted territory it seems.
Age: 25 | Onset Age: 21 | Symptoms: Pain in perineum area, bad ED, slower stream, loss of libido, | Helped By: Uroxatral, Heavy Doses of NSAIDs, Really Hot Baths/Sauna | Worsened By: Sex, Masturbation, Spicy Foods, biking, certain exercises, sudafed| Other comments: Mine started in a time after copious amounts of sex, I also held in ejaculation for a long long time after a sex break which may have contributed. Also went from protected to unprotected sex around this same time, but all tests show no bacteria. I do not have urgency issues.
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Re: New study starting

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Just an FYI: The person I spoke to today gave me some insight on this medication. She told me it was a new classification of a NSAID. Other than that, she didn't get too deep with the info.
Age: 52 | Onset Age:49 (but I may have had warning signs 25 yrs earlier)| Symptoms: Pretty much all the usual suspects. Frequency, urgency, inability to always empty, burning and numbing uretheral, penile & perineum pain. Frequent urination at night.| Helped By: Internal PT. Myrbetriq helps but is by no means great. TENS to help sleep, and hand held massages of the lower back, hips and buttocks. Standing and physical labor help. Stretches and hot baths. Occasionally use gel iced pad on the perineum. Worsened By: Sitting (being sedentary), driving, sex, bowel movements, tight clothing and underwear. | Other comments: Currently trying L-Theanine
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Re: New study starting

Post by HateCPPS »

I talked to a representative yesterday and it sounds like you need to make like 5/6 visits at these specific test sites to see an ophthalmologist. I read on a different forum that they discovered during animal testing that some animals developed cataracts. Little sketched out on this. That would be all I need is to go blind trying to fix my prostate problem. Not sure if they are finding it's only an animal thing and not replicating in humans or not. But definitely suggest doing your research.

Curious to what some of the real science buffs have to say about the thought behind the mechanics of this one.
Age: 25 | Onset Age: 21 | Symptoms: Pain in perineum area, bad ED, slower stream, loss of libido, | Helped By: Uroxatral, Heavy Doses of NSAIDs, Really Hot Baths/Sauna | Worsened By: Sex, Masturbation, Spicy Foods, biking, certain exercises, sudafed| Other comments: Mine started in a time after copious amounts of sex, I also held in ejaculation for a long long time after a sex break which may have contributed. Also went from protected to unprotected sex around this same time, but all tests show no bacteria. I do not have urgency issues.
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Re: New study starting

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Cataracts blindness. 40%+ of people aged 75 have cataracts.

Do you have anything reliable besides internet gossip to back up the cataract story?
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Re: New study starting

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Cataracts were seen in one animal species tested (but not others). Drug has been given to several hundred humans in different clinical trials and so far the incidence in cataract development or progression has been the same in those getting drug and those getting placebo. The FDA has mandated careful monitoring by an opthalmologist for the phase II and III trials with the drug. There is an upcoming study in IC whose sole purpose is following eye exams out to 18 months.
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Re: New study starting

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Please note, this study has been cancelled. The most recent study on IC failed to reach its primary endpoint and the company is pulling the plug on further developement. A pity.
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Re: New study starting (now cancelled)

Post by HateCPPS »

Bummer, looks like their stock is doing pretty well now.
Age: 25 | Onset Age: 21 | Symptoms: Pain in perineum area, bad ED, slower stream, loss of libido, | Helped By: Uroxatral, Heavy Doses of NSAIDs, Really Hot Baths/Sauna | Worsened By: Sex, Masturbation, Spicy Foods, biking, certain exercises, sudafed| Other comments: Mine started in a time after copious amounts of sex, I also held in ejaculation for a long long time after a sex break which may have contributed. Also went from protected to unprotected sex around this same time, but all tests show no bacteria. I do not have urgency issues.
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