sIGF-I levels were reduced by a mean of 38% (28 – 48%) in the 3 patients who had lower body weights (58 – 83 kg at screening) and thereby received a relatively higher dose per kg bodyweight. The one patient showing the lowest sIGF-1 reduction at week 14 had the highest body weight (132 kg at screening). At the 200 mg per week dose, no consistent reduction in mean sIGF-I levels was observed at week 14, although some sIGF-I reduction was noted in individual patients. The time course data (see Figure 1) at the 400 mg per week dose generally shows a progressive rate of reduction in sIGF-I over the dosing period. This is further support for the therapeutic action of ATL1103 observed in this trial and suggests that continued dosing of ATL1103 at the 400 mg per week dose for longer than 3 months could result in additional reductions in sIGF-I. While sIGF-I levels were substantially suppressed in 3 patients receiving the 400 mg per week dose of ATL1103, their sIGF-I levels did not reduce all the way to normal levels, however this is not surprising considering the study design was not optimised for this endpoint, the small number of patients analysed thus far and that their starting sIGF-I levels (2.4 to 5 times above normal) appear higher when compared to average starting levels of acromegaly patients in larger published clinical studies (e.g. 1.8 times above normal).
Can-Fite reports positive results from CF101 Phase IIb study for rheumatoid arthritis
So, if we ever got a Lateral Flow Device where the control line didn’t light up blue, then the device hasn’t worked and we would repeat the test. But in all honesty, in the thousands we’ve tested, that’s never happened because it’s designed not to happen. If you end up with a ‘T’ line that is blue as well as a control line that is blue, you know that pepsin is present in the sample. We’ve also developed what we call a Lateral Flow Device reader so that we can read off the intensity of the blue lines in nanograms per ml of pepsin. This means a report can be generated, whether it be for doctors or patients, that will provide some idea of the level of pepsin present in the sample Some doctors only want to know whether pepsin is present or not, but others, especially the ones in research, want to know how much because they may want to put the patient onto a treatment regime, and maybe retest them at a later date to see if levels have reduced. Also, if they are going to perform anti -reflux surgery, it means they will be able to compare a pre- and post-surgical reading to see if the pepsin levels have reduced or disappeared.
But In All Honesty, In The Thousands We’ve Tested, That’s Never Happened Because It’s Designed Not To Happen.
Reflux disease diagnosis: an interview with Professor Peter Dettmar, Managing Director of RD Biomed Limited
Can-Fite reports positive results from CF101 Phase IIb study for rheumatoid arthritisCan-Fite reports positive results from CF101 Phase IIb study for rheumatoid arthritisPublished on December 23, 2013 at 8:31 AM · No CommentsCan-Fite BioPharma Ltd. (TASE: CFBI), (NYSE MKT: CANF), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced results from a 12-week, placebo-controlled Phase IIb study involving 79 patients with active rheumatoid arthritis (“RA”) for its proprietary drug CF101, an A3 adenosine receptor (“A3AR”) agonist. The study entailed 2 arms, a placebo and a CF101 1 mg treated group, in which CF101 was administered orally twice-daily as a monotherapy for 12 weeks to patients with RA. Only patients with elevated baseline expression levels of the biomarker A3AR were enrolled in the study. In the study, CF101 1 mg met all primary efficacy endpoints, showing statistically significant superiority over placebo in reducing signs and symptoms of RA as compared to the placebo, as measured by ACR20 response rates at 12 weeks (ACR20 response rates: placebo = 25%; CF101 = 49%,s observations in the previously reported CF101 psoriasis trials, the response of patients with RA was cumulative over time, suggesting a consistent anti-inflammatory effect of CF101. Moreover, half of the RA patients treated with CF101 showed clinically meaningful improvement.CF101 was very well-tolerated with no evidence of immunosuppression. CF101 had an excellent safety profile, as has already been shown in more than 750 patients in previously reported Phase II clinical studies in autoimmune and inflammatory diseases. Additionally, all treatment-emergent adverse events were mild to moderate in intensity.