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Author Topic: CYT-107 Trial  (Read 8950 times)

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Offline Pasuiseki63

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  • Posts: 16
CYT-107 Trial
« on: February 10, 2009, 06:15:53 PM »
Anybody here in the Cytheris IK-7 Trial?

Offline veritas

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  • Posts: 1,410
Re: CYT-107 Trial
« Reply #1 on: February 11, 2009, 05:35:46 AM »

Pasuiseki63,

I'm not in the trial but it sure looks intriguing:

http://www.medicalnewstoday.com/articles/83809.php


I especially liked this paragraph:

Forum participants expressed particular interest in pursuing various avenues of IL-7 investigation including: 1) Oncology, in association with chemo- and immunotherapy; 2) HIV infection, to reconstitute the immune system and trigger an anti-viral response, potentially limiting the incidence of AIDS-related and non-related pathologies; 3) HCV infection, to speed viral clearance and increase the proportion of patients able to clear the virus; and, 4) various other chronic infections such as tuberculosis.

veritas

Offline Pasuiseki63

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Re: CYT-107 Trial
« Reply #2 on: February 11, 2009, 08:10:56 AM »
I was in the second round (20micrograms/kg) and had pretty good results.  Just wondering about anyone else.

Offline veritas

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Re: CYT-107 Trial
« Reply #3 on: February 11, 2009, 08:26:43 AM »

Pasuiseki63,

That sounds great. Are you allowed to give any details with respect to your results and the trial itself(ie:viral load,cd4%,cd4 count, Adverse reactions, dosing schedule)? I fully understand that some trials ask the participants  to keep info confidential, but if that is not the case, I'd love to hear the details.

veritas

Offline Pasuiseki63

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  • Posts: 16
Re: CYT-107 Trial
« Reply #4 on: February 11, 2009, 10:04:18 AM »
Veritas,

my load stayed <50, it was just 3 injections (1 a week for three weeks)  the highest my cd4 went was 225% above baseline,  since oct. its been averaging around 80% from baseline.  I'm in week 26 right now.

Offline veritas

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Re: CYT-107 Trial
« Reply #5 on: February 11, 2009, 10:24:56 AM »

Pasuiseki63,

If your vl stayed below 50 after 3 injections for 26 weeks and you are not on any other ARVs, that's an amazing result ! What was your baseline cd4 count? How were your lipids? And no adverse reactions?

Sorry for all the questions but this therapy sounds very promising. It's nice to be able to discuss with someone who was actually in the trial.

veritas

Offline georgep77

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  • Posts: 148
Re: CYT-107 Trial
« Reply #6 on: February 11, 2009, 10:31:13 AM »
Pasuiseki63,

If your vl stayed below 50 after 3 injections for 26 weeks and you are not on any other ARVs

veritas
Awesome results...I must say
Come on Sangamo,  Geovax,  Bionor immuno, ...Make us happy !!!
+ 2008

Offline Pasuiseki63

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  • Posts: 16
Re: CYT-107 Trial
« Reply #7 on: February 11, 2009, 10:47:09 AM »
Part of the protocol was that you had to be on ARV for at least 12 months before the trial (atripla for me)  Lipids are slightly elevated.  Adverse reactions were fever and malaise for up to 24 hours after injection and site reaction (rash) also liver enzymes were elevated (expected)

Offline veritas

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Re: CYT-107 Trial
« Reply #8 on: February 11, 2009, 12:45:40 PM »

May I assume from your post above that the ARVs were stopped upon commencing the trial therapy and did the adverse effects straighten themselves out after the 24hrs. Also, what was the baseline cd4 count?

Sounds fantastic so far.

veritas

Offline Pasuiseki63

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  • Posts: 16
Re: CYT-107 Trial
« Reply #9 on: February 11, 2009, 01:23:32 PM »
ARV's were not stopped during the trial.  Baseline was 380.  Yes, symptoms of the therapy lasted a max. of 24 hrs. (i.e fever/malaise)

Offline veritas

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Re: CYT-107 Trial
« Reply #10 on: February 11, 2009, 05:16:14 PM »
I should have picked-up this statement before posting above:


"These trials also follow the successful completion of four Phase I studies and are designed to investigate IL-7's potential for building immune system response. "

Your immune system has certainly responded to Il-7, since your cd4s increased 225% from baseline and are still at 80% above baselne. What's fascinating is that this result occured in a phase 1 study.


This therapy has the potential to help many re-constitute their immune systems.

IL-7 is one to watch !

veritas
« Last Edit: February 11, 2009, 05:18:17 PM by veritas »

Offline Pasuiseki63

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  • Posts: 16
Re: CYT-107 Trial
« Reply #11 on: February 11, 2009, 05:30:18 PM »
They are about ready to start the 30 microgram/kg part of the study from what i hear.  They will have 10 people in that group.  I was the only one at the center at 20micros in that phase so i have no idea what other results are/were.  They will follow me for 48 weeks.

Offline freewillie99

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  • Posts: 310
Re: CYT-107 Trial
« Reply #12 on: February 12, 2009, 07:35:24 AM »
Pasuiseki63:

Thanks for sharing your experience.  Very interesting thread.

I'm curious whether you've noticed an improvement in your overall sense of well being and health after receiving the therapy?

Cheers.
Beware Romanians bearing strange gifts

Offline Peter Staley

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  • Founder & Advisory Editor, AIDSmeds.com
    • AIDSmeds.com
Re: CYT-107 Trial
« Reply #13 on: February 12, 2009, 09:03:50 AM »
A strong word of caution about getting our hopes up here.  Using one of the interleukins to raise CD4s doesn't actually mean those extra CD4s help the patient.

After testing IL-2 for over 15 years, we learned that it did a great job of raising folks CD4s, but did NOTHING to prevent OIs or death:

http://www.aidsmeds.com/articles/hiv_esprit_silcaat_proleukin_1667_16084.shtml

I actually know quite a few people that went through years of pretty bad IL-2 side effects, but kept doing it because their CD4s increased.  Now we know those extra CD4s didn't do much of anything for them.

I'm not saying the same thing will happen with IL-7, but it could.

Offline veritas

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Re: CYT-107 Trial
« Reply #14 on: February 12, 2009, 09:49:41 AM »

Peter,

Your words of caution are wise. What gives me hope about Il-7 is that in cancer trials done on humans they found the cd4s to be fully functional :

http://www.medscape.com/viewarticle/577102

"Treatment with rhIL-7 also seems to have advantages over rhIL-2, explained Dr. Sportès. The expanded T cells retained significant functional capacity, and the CD4+ T cell expansion was not accompanied by a disproportionate increase in T regulatory cells, a phenomenon that has been observed after rhIL-2 therapy. Previous data have shown that in vivo IL-2 administration in humans has minimal effects on CD8+ T cell numbers, whereas rhIL-7 effects on CD8+ T cell expansion are at least comparable to the effects on CD4+ T cells."

This therapy, so far , doesn't seem to have the pitfalls of Il2. The trials will tell.

veritas

Offline Pasuiseki63

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  • Posts: 16
Re: CYT-107 Trial
« Reply #15 on: February 12, 2009, 10:11:37 AM »
This is the first human trials of this form of IL-7.  There are 10 people each of the 3 dosing levels (30 people total) in four countries. 

Offline veritas

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  • Posts: 1,410
Re: CYT-107 Trial
« Reply #16 on: February 12, 2009, 10:21:42 AM »

Pausiseki63,

There seems to be a lot of clinical trials for Il-7 in general:

http://clinicaltrials.gov/ct2/results?term=IL-7

veritas

Offline Pasuiseki63

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  • Posts: 16
Re: CYT-107 Trial
« Reply #17 on: February 12, 2009, 10:43:14 AM »

Offline stargate12

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  • Posts: 30
Re: CYT-107 Trial
« Reply #18 on: February 12, 2009, 11:16:46 AM »

Offline Pasuiseki63

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  • Posts: 16
Re: CYT-107 Trial
« Reply #19 on: February 12, 2009, 11:23:43 AM »
It was not required for me to stop HAART.

Offline Pasuiseki63

  • Member
  • Posts: 16
Re: CYT-107 Trial
« Reply #20 on: September 06, 2009, 08:33:15 AM »
Just a quick update.....The IL-7 trial i was in is over for me ( Its been a year).  I was able to maintain a 45% increase in CD4 levels with no obvious side effects.  The 30ug study is currently underway.

Offline Carlos3000

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  • Posts: 30
Re: CYT-107 Trial
« Reply #21 on: September 15, 2009, 06:16:05 PM »
more news about cyt-107
new?

 9/15/09 - Cytheris Announces Interim Data from INSPIRE Study Showing Interleukin-7 (CYT107) Induces Dose-Dependent and Sustained Increase of CD4 T Cells in Chronic HIV-Infected Patients 
PARIS(BUSINESS WIRE) Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced presentation of data from an interim analysis of CLI-107-06 (INSPIRE), a Phase I/IIa study of HIV-infected patients with low CD4 T cell counts. The patients were treated with a three-injection cycle of the Company's investigative immune-modulator, recombinant human Interleukin-7 (CYT107). The analysis shows that CYT107 induces a dose dependent and sustained increase of CD4 T cells with many patients achieving CD4 counts > 500 cells/mm3. The INSPIRE data were presented during an oral late breaker session at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held September 12-15, 2009, in San Francisco, CA (Abstract H-1230a).

Even in the HAART era, it appears that low CD4 T cell counts place HIV infected persons at greater risk for a variety of serious morbidities. This study shows that treatment with IL-7 can increase CD4 T cell counts in many of these patients to levels that are within the normal? range. We now need to know whether these increased CD4 T cell counts confer protection from these serious complications,? said Michael M. Lederman, MD, the Scott R. Inkley Professor of Medicine at Case Western Reserve University, Cleveland, Ohio, Associate Director, CWRU/UHC Center for AIDS Research, and Chairman of the INSPIRE study.

The interim results with CYT107 closely mimic and even improve upon those seen in a recently published study1 in chronic HIV-infected patients treated with an earlier, non-glycosylated version (CYT 99 007) of Cytheris IL-7," said Yves Levy, MD, PHD, Scientific Director of the French National Agency for Research on AIDS and Viral Hepatitis (ANRS) Vaccine Program, Service d'Immunologie Clinique, Hpital Henri Mondor, Crteil, France and Inserm, Presenter, Principle Investigator and Co-Chair of the INSPIRE study. "These results show that 3 injections of IL-7 are sufficient to expand naive and memory T cells in the long term. Further studies are needed to demonstrate whether these biological effects translate into clinical benefits.?

About the Study (CLI-107-06)

INSPIRE is a Phase I/IIa randomized placebo controlled, single-blind multicenter (Europe, US, and Canada) dose-escalation study of subcutaneous intermittent glycosylated Interleukin-7 (CYT107) in chronically HIV-infected patients with CD4 T-lymphocyte counts between 101-400 cells/mm3 and plasma HIV RNA< 50 copies/mL after at least 12 months of HAART. Patients selected in this trial are categorized as immunological low or non responders (INR), i.e. patients who have not optimally restored their immunity despite at least 12 months of HAART and with complete control of HIV replication.

INR patients represent from 5 to 30% of the HIV treated population, the prevalence of which depends on the definition criteria, which are used to characterize them. As shown in large cohorts, the risk of disease progression or death is significantly higher in the INR sub-population when compared to patients who achieve better T cell restoration.

Methods: Chronically HIV-infected patients with 101-400 CD4 cells/mm3 and plasma HIV RNA< 50 cp/mL while on ART received three weekly subcutaneous injections of CYT107. Three doses were tested: 10, 20 or 30 g/kg/week (8 patients CYT107 vs 2 placebo per dose). Phenotypic analyses of T cell subsets and thymopoiesis surrogate markers (RTE and sj/TRECs ratio quantification) were performed.

Results: No clinical or laboratory side effects > grade 2 were recorded. In the 20g/kg group, 4 patients experienced a transient increase of HIV RNA values (<500 cp/mL in 3 of 4 and 1023 cp/mL in 1). The biological activity of CYT107 is shown below:

10g/Kg   Baseline
(median T cells/mm3)
  Day 28
(median T cells/mm3; % increase)
  Week 12
(median T cells/mm3; % increase)
  P value
Baseline vs W12

(Wilcoxon test)
 
CD4   268   643 (152%)   419 (87%)   0.006 
CD8   761   1434 (91%)   1081 (42%)   0.006 
Naive CD4   41   82   93   0.016 
RTE CD4   3   6   4   NS 
Sj/TREC ratio   12   18   25   NS 
20g/Kg         
CD4   240   709(205%)   563 (135%)   0.004 
CD8   659   1695 (131%)   1210 (65%)   0.004 
Naive CD4   66   218   136   0.016 
RTE CD4   5   21   5   NS 
Sj/TREC ratio   17   36   26   0.062 

(Total and naves CD4 and CD8 increases are statistically significant vs. placebo group (P<0.005). 1/7 and 5/8 of pts experienced CD4 counts > 500 cells/mm3 at week 12 (P<0.005) at the 10 and 20mcg/kg dose respectively.)

Conclusions: A three-injection cycle of CYT107 induces a dose dependent and sustained increase of CD4 T cells. A higher proportion of patients experienced CD4 T cell counts > 500 cells/mm3 and a trend toward higher thymic output at the 20mcg/kg dose.

The design of the trial allows for an assessment of potential individual benefits in patients whose CD4 T cell count is suboptimal at baseline despite complete control of HIV replication under HAART. Such benefit may correspond to a sustained expansion of CD4 T cells, and potentially, a decrease in morbidity and mortality which is increased in this sub-population of patients compared to those who restore a higher CD4 T cell count after several months of HAART.

The interim analysis of INSPIRE data presented here further strengthens the potential role of CYT107 as a potent and safe immune modulator which is capable of dramatically increasing both CD4 and CD8 T cell counts in HIV-infected patients,? said Thrse Croughs, MD, Chief Medical Officer of Cytheris. The median CD4 and CD8 T cell increases per mm3 over baseline, from 240 to 563 (135%) and from 659 to 1210 (65%), respectively, at the 20mcg/kg dose, clearly indicate the potential of this cytokine to play a significant role in HIV therapy and more than justifies its further clinical development.?
 


http://www.pharmacychoice.com/News/article.cfm?Article_ID=455760
atripla

09/10      cd4 564  Und  30 %

Offline brazilianman

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  • Posts: 92
Re: CYT-107 Trial
« Reply #22 on: September 16, 2009, 10:07:00 AM »
good news

 ;D good days are ahead  ;D

Bman

Offline Pasuiseki63

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  • Posts: 16

Offline Carlos3000

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  • Posts: 30
Re: CYT-107 Trial
« Reply #24 on: October 14, 2009, 06:13:15 PM »
Study to Focus on Immunotherapy for Treatment of Idiopathic CD4 Lymphocytopenia
(ICL), a Rare Condition for Which No Treatment Currently Exists
PARIS--(Business Wire)--
Cytheris SA, a clinical stage biopharmaceutical company focused on research and
development of new therapies for immune modulation, today announced the
initiation of a Phase I/IIa ........

http://www.reuters.com/article/pressRelease/idUS88923+14-Oct-2009+BW20091014
atripla

09/10      cd4 564  Und  30 %

Offline Pasuiseki63

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Re: CYT-107 Trial
« Reply #25 on: December 19, 2009, 09:37:33 AM »
Just an update.....Cd4 is 640   68% up

Offline veritas

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Re: CYT-107 Trial
« Reply #26 on: December 19, 2009, 03:08:54 PM »

Pasuiseki63,

Being able to maintain a cd4 count well into the normal range after more than a year is a fantastic result!
Were they able to determine if the cd4's were fully functional in the HIV setting?

Great news!

v

Offline Pasuiseki63

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Re: CYT-107 Trial
« Reply #27 on: December 20, 2009, 11:27:49 AM »
Thanks for the feedback Veritas.  I have no idea on functionality as of yet.  All i know is that I'm healthy. The increase at least makes me feel better mentally.  A few years ago I was down to 125.  I'll keep updating as i get more results.

Offline Pasuiseki63

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  • Posts: 16
Re: CYT-107 Trial
« Reply #28 on: February 28, 2010, 02:07:40 PM »
If anyone whats to ask me about the trial.... feel free.   

Offline veritas

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Re: CYT-107 Trial
« Reply #29 on: February 28, 2010, 03:07:25 PM »

Pasuiseki63,

Good to hear from you again. Was hoping you would post again.

 Any further data to report? Functionality? Are your counts being maintained?
Still no AEs?

v

Offline Inchlingblue

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  • Chad Ochocinco PETA Ad
Re: CYT-107 Trial
« Reply #30 on: February 28, 2010, 04:09:02 PM »
If anyone whats to ask me about the trial.... feel free.   

lol, of course we do . . . can you give an update?

Thanks ;)

Offline Pasuiseki63

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  • Posts: 16
Re: CYT-107 Trial
« Reply #31 on: May 19, 2010, 04:46:47 PM »
Just an update.....cd4 598 (57% over baseline)  load in undetectable

 


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