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AFC Enterprises, Inc. Message Board

beepeeess 31 posts  |  Last Activity: Jul 9, 2014 11:02 AM Member since: Oct 10, 2012
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  • All this senseless selling going on with no merit. So now CTP-499 can also be used for lung, heart, and other problems and that's bad news? Come on people. Do I look like a fool?

  • The stock hasn't even had a chance to go up yet.

  • Reply to

    very interested in

    by inhxgoldy May 8, 2014 10:04 AM
    beepeeess beepeeess May 8, 2014 12:10 PM Flag

    how do you know it was an institutional investor?

  • Reply to

    Bought Back in, Oversold short squeeze next!

    by thetrdr May 2, 2014 3:22 PM
    beepeeess beepeeess May 2, 2014 5:10 PM Flag

    what announcement?

  • Reply to

    I'm out of this board

    by fedrally001 May 1, 2014 8:29 PM
    beepeeess beepeeess May 2, 2014 12:28 PM Flag

    How high do you think the stock will go now?

  • Reply to

    Can the naysayers tell me ..

    by fedrally001 Apr 29, 2014 10:29 PM
    beepeeess beepeeess Apr 30, 2014 12:23 AM Flag

    Unfortunately, Celgene didn't buy any CNCE stock. They just have a collaboration with them. The only bio-tech that owns shares of CNCE is GSK and they are no longer collaborating with CNCE. I'm not sure why they bought shares even though their collaboration was over. The reason their collaboration didn't work out is because GSK wanted to use a different strategy to improve their own drugs. What strategy they chose remains a mystery. What would make their drugs better than using deuterium? That makes you think there's something better out there, but what? And yet they still chose to invest in CNCE. Remains a mystery.

  • – CTP-499 observed to protect against large increases in serum creatinine –

    – CTP-499 reduced biomarkers of fibrosis –

    – Data presented at late-breaking session at the National Kidney Foundation Spring Clinical Meeting –

    LAS VEGAS--(BUSINESS WIRE)--Concert Pharmaceuticals, Inc. (NASDAQ:CNCE) today announced 48-week results of its Phase 2 clinical trial of CTP-499 in patients with diabetic kidney disease. CTP-499, when used in addition to the standard of care, is being developed to delay the progression of these patients to end-stage renal failure, which requires dialysis or kidney transplantation. The results suggest that CTP-499 has protective effects on kidney function in patients with type 2 diabetic kidney disease, a condition in which kidney function is progressively lost. In addition, an observed, statistically significant reduction of certain fibrotic biomarkers suggests that CTP-499 may act as an anti-fibrotic agent. The results were presented today during a Late-Breaking session at the National Kidney Foundation 2014 Spring Clinical Meeting by Dr. Bhupinder Singh, a clinical investigator and Medical Director of Apex Research of Riverside.

    “The results of this Phase 2 trial after 48 weeks were highly encouraging and, I believe, support the progression of CTP-499 into larger clinical trials. Overall, these data suggest that CTP-499 may protect patients from suffering loss of kidney function by reducing the progression of fibrosis,” said Dr. Singh. “Fibrosis is believed to be a final common pathway for kidney failure due to diabetic kidney disease, a gradual process that occurs over the course of years. Importantly, the biomarker data suggesting predominately anti-fibrotic activity may explain why CTP-499 treatment required a 48 week treatment period to demonstrate a clinical effect.”

    Dr. Singh added, “There is an enormous need for new mechanisms, such as inhibition of fibrosis, to treat chronic kidney disease. A new treatment that is well-tolerated and slows the progression of disease could potentially have a major impact on patients’ lives.”

    The Phase 2 trial was a placebo-controlled, multi-center trial involving three parts:

    Part 1—a double-blind, randomized, parallel, two-arm, placebo-controlled study evaluating the safety and efficacy, as measured by urinary albumin to creatinine ratio (UACR), of 600 mg CTP-499 twice daily for 24 weeks. 151 of 182 patients enrolled completed Part 1.
    Part 2—an optional blinded extension study in which all patients who completed Part 1 were eligible to continue receiving 600 mg of CTP-499 or placebo twice daily for an additional 24 weeks. 123 of 143 patients enrolled completed Part 2.
    Part 3—all patients who completed Part 2 were eligible to continue with up to 48 weeks of open-label treatment and receive 600 mg of CTP-499 twice daily. This open-label study is ongoing.

    At 48 weeks, a measurable impact on serum creatinine, a key secondary endpoint, was observed. Increased serum creatinine is a marker of impaired kidney function. These data may indicate a slower decline of kidney function in patients treated with CTP-499 compared to those who received placebo.

    The mean serum creatinine level in the 65 patients receiving CTP-499 increased by 0.13 mg/dL compared to an increase of 0.21 mg/dL in the 58 patients receiving placebo through the 48 weeks of treatment (p = 0.057), reflecting a 38% improvement.
    Six out of the 58 patients receiving placebo, or 10.3%, experienced a 50% or greater increase in serum creatinine levels after 48 weeks compared with one out of the 65 patients receiving CTP-499, or 1.5% (p = 0.026).

    The primary endpoint of the trial was the change after 24 weeks in UACR, a marker of kidney tissue damage. While the trial did not meet this endpoint, at 48 weeks the longer-term treatment duration suggests a favorable trend in UACR for patients receiving CTP-499 as compared to placebo. At 48 weeks, UACR in patients receiving CTP-499 increased 24 mg/g from baseline compared to 223 mg/g increase in patients receiving placebo (p = 0.097). These data may indicate a stabilization of UACR in patients treated with CTP-499 compared to those who received placebo.

    The treatment effects observed at 48 weeks were accompanied by statistically significant changes in urinary fibronectin and plasma collagen IV, two fibrotic biomarkers evaluated in the Phase 2 trial. Treatment with CTP-499 resulted in 52% less urinary fibronectin (p = 0.0081) and 18% less plasma collagen IV (p = 0.022) after 48 weeks compared to placebo. As with other endpoints in the Phase 2 trial, no significant changes in fibronectin and collagen IV were observed after 24 weeks of treatment, whereas significant effects in these biomarkers were seen after 48 weeks of treatment.

    Treatment with CTP-499 was generally well tolerated. Gastrointestinal events were reported more frequently in the CTP-499 arm, with mild to moderate nausea being the most commonly reported event. There were a total of 33 patients with at least one serious adverse event reported in the trial; none of these serious adverse events were judged by the investigators to be possibly related to study drug. These events occurred in 20% of patients receiving CTP-499 and 17% of patients receiving placebo. Fewer patients dropped out of the CTP-499 arm than the placebo arm throughout the course of the trial.

    “We are encouraged by our 48-week CTP-499 data and have submitted an end of Phase 2 meeting request to the FDA to discuss our development pathway and potential Phase 3 endpoints,” said Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. “Diabetic kidney disease is now the nation’s leading cause of dialysis, kidney transplant and death from kidney failure. We believe that CTP-499 has a novel mechanism of action for diabetic kidney disease and has the potential to provide a new treatment option for patients with this debilitating and life-threatening condition.”

  • The results, at first blush, don’t look good. The study didn’t hit its pre-specified main goal, which was to show that patients who took CTP-499 for 24 weeks had better numbers on a measure of kidney damage, the urinary albumin to creatinine ratio (UACR), than patients who were dosed with a placebo. Yet to hear Concert executives talk today, CTP-499 still has a bright future and a reasonable chance of succeeding in a big Phase 3 study. Concert is pointing to the fact that patients taking CTP-499 for 48 weeks had better measures of serum creatinine—a waste product that builds up when damaged kidneys fail to filter it from the blood—compared to the placebo group. And data on two other biomarkers indicate the drug might protect the kidneys from scarring, according to Concert.

    Concert CEO Roger Tung (pictured above) argues those secondary data are actually more important. A big effect on serum creatinine would be a statistic that the FDA would value more highly than UACR, Tung says.

    “UACR measures tissue damage, but it doesn’t really measure the ability of the kidneys to filter blood, and that is functionally what you want your kidneys to do,” Tung says. “What we saw were unpromising results on a biomarker that’s probably not ultimately relevant, and longer term positive results on a measure of kidney function that we think really tells the story about the drug.”

  • It sounded pretty decent to me. :0(

  • beepeeess by beepeeess Apr 25, 2014 11:56 AM Flag

    Is this stock really still going down? On what cause?

  • Is there any upward momentum to this stock at all? It just keeps going down, even with a presentation on tap. How can investors bail out when they haven't even bought in? Insiders would have to sell to make the price go down this much. How are the market makers pulling this #$%$ off?

AFCE
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