Hi everyone - vertex 950 update

I hope everyone is doing well.  Foreseegood and I were talking about considering the possibility of participating in the vertex 950 trials a while back and I just wanted to update.  I have one more, hopefully, small hurdle and if all goes well, I'll be accepted into the study at Johns Hopkins in Balto.  I'd be starting August 8th.  The hurdle I mentioned above is that during my first screening, my thyroid levels were pretty elevated and that would have kept me out of the study group.  Re-tested through my doc's office and results were normal so we're hoping somehow that Hopkins screwed or skewed the results in some way.  Re-tested again today through Hopkins and if results are good, I'm definitely starting.  Of course, I won't know which arm I'll be in.  I did get lots of info about the required "Protocols" etc. so if anyone needs to know anything about the studies,I may just happen to know the answer to something, for once.

One thing I found interesting is that no rescue drugs are prescribed for the first 12 weeks.  After that, rescue drugs are good to go.  They will provide a transfusion, if necessary.  I'm really impressed by the level of professionalism and efficiency.  It's blowing me away.  They seem to be awesome, so far.

Foreseegood, if you happen to catch this, let me know how you're proceeding with your participation in the study.  My computer crashed in June so I've been completely out of touch and don't know how to reach you anymore.  Hope to hear from you.
Char

[Kalio1]

Thanks so much for the update. That seems like good news that they wi allow rescue drugs after 12 weeks and having a high evel of professionalism sure helps. I hope you get in and it works out well for you. Thanks again for the news, please keep in touh if you can I know everyone is interested in the trials.

[ohgreat]

Hey thats great news!  Hope you get i, get SVR, and my stock goes up more!!!

I have been wondering if Vertex will be good for people like me with Geno 3a.  I wonder if all these great SVR results they have been getting would reduce treatment time on all the Genos overall.  Like maybe I would only have to treat for 6 or 12 months vs. 12 or 24 months.

Are they doing any studies on Genos 2 or 3?  I know that 1 and 4s need it most.

Either way best of luck to you!

[Kalio1]

There is no SVR data yet on VX950. I think what you might be referring to is the high viral clearance rate and/or the speed at which they achieved undetectable status using VX950.

[Upbeat]

Are you trying to get into the non responder trial?   Here is the Gov clinical trials info.



http://www.clinicaltrial.gov/ct/show/NCT00336479?order=1



                                                           Ron

[hippygem]

How are you kalio, long time no see.
Ive posted below in another thread about whats happenin atm, but in September i will know more about the trial that im on and the results.
All good at this time, got more energy, feeling better within myself just now, sorry about the low confidence posts i wrote about earlier, i was on such a downer, not healthy is all i can say.
Ive worked things out a bit better within myself and just going one step at a time.
Hows things with you, hows the hep making you feel.
Catch up with you soon.

Linda

[FlGuy]

Ron,  That appears to be Geno 1, tx naive

[miked]

The link you gave is for tx naive patients.  Does anyone have any information yet about the non-responder trials?  

Also can anyone tell me how they will select the medical centers for the upcoming trials?  I go to IU Med. Center which is not participating in the tx naive trials...so will IU be included in the non-responder trials?

Thanks,

Mike

[FlGuy]

If you can do a little reasearch (clinicaltrials.gov) you might be able to find the name and number of a person at IU who was involved in other HCV drug trials (a doc investigator or a study coordinator). Then, try to call that person to see if IU expects to be involved in any VX (or other HCV trials that might fit you).  I went to the extent of making an appointment with such a hepatologist (local Univ involved in current VX trial) Although I have to pay $$ for the appt (ins. won't cover)I think it may be worth it if nothing else to let them know who I am, hcv characteristics and let them know I'm interested and available for PI trials. I decided to at least look into PI's before I head back to traditional combo tx.

[GrandOak]

Sorry to tell ya but 2Q news was not kind to your stock.  Hopefully it rebounds with favorable VX950 news.

[ohgreat]

"Sorry to tell ya but 2Q news was not kind to your stock. Hopefully it rebounds with favorable VX950 news."

the ups and downs dont matter, what matters is that they can move a popular product in 2008.  im in it for the long haul.

[Kalio1]

Hey Forsee where ya been? I figured you were in a pool somewhere trying to stay cool in the heat. Hasn't been bad here, a little humid from that storm pushing up from Mexico.
I bet you are glad you aren't in Woodland Hills! Whew! 119, now that is HOT. Hope you are on the beach side of things and you are doing OK

[miked]

Paul Kwo is the lead hepatologist at IU Medical Center.  He said that IU tried to get in on the Vertex tx naive trials but stumbled with the legal documents.

IU is conducting a trial with Schering's PI but I want to hold out for Vertex because the results seem much more promising.

The following sites are performing the tx naive VX-950 trial now underway....is it logical that they will be the only sites for the non-responder trials or will other sites (IU) be participating???  

CTOAN...any information here?

________________________________________________________________

Colorado
      South Denver Gastroenterology, Englewood,  Colorado,  United States; Recruiting
Marcello Kugelmas, MD,  Principal Investigator


Florida
      Shands Hospital University of Florida, Gainesville,  Florida,  32610,  United States; Recruiting
David R. Nelson, M.D.,  Principal Investigator


      Call for Information, Miami,  Florida,  United States; Recruiting
Call For Information,  Principal Investigator


Louisiana
      Gulf Coast Research Associates, Baton Rouge,  Louisiana,  United States; Recruiting
Shaban Faruqui, MD,  Principal Investigator


Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  United States; Recruiting
Nezam H. Afdhal, M.D.,  Principal Investigator


      Call for Information, Boston,  Massachusetts,  United States; Recruiting
Call For Information,  Principal Investigator


      Call For Information, Worcester,  Massachusetts,  United States; Recruiting
Call For Information,  Principal Investigator


Michigan
      Henry Ford Health System, Detroit,  Michigan,  United States; Recruiting
Stuart Gordon, MD,  Principal Investigator


Minnesota
      Call For Information, Rochester,  Minnesota,  United States; Recruiting
Call For Information,  Principal Investigator


New Mexico
      University of New Mexico, Albuquerque,  New Mexico,  United States; Recruiting
Sanjeev Arora, MD,  Principal Investigator


New York
      Call for Information, New York,  New York,  United States; Recruiting
Call For Information,  Principal Investigator


      Call For Information, Manhasset,  New York,  United States; Recruiting
Call For Information,  Principal Investigator


Pennsylvania
      University of Pennsylvania Hospital, Philadelphia,  Pennsylvania,  United States; Recruiting
Rajender Reddy, MD,  Principal Investigator


Texas
      Alamo Medical Research, San Antonio,  Texas,  78215,  United States; Recruiting
Eric J. Lawitz, M.D.,  Principal Investigator


      Methodist Hospital of Dallas, Dallas,  Texas,  United States; Recruiting
Reem Ghalib, MD,  Principal Investigator


      University of Texas Southwestern Medical Center at Dallas, Dallas,  Texas,  United States; Recruiting
William Lee, MD,  Principal Investigator


Virginia
      McGuire VA Medical Center, Richmond,  Virginia,  23249,  United States; Recruiting
Mitchell Shiffman, M.D.,  Principal Investigator


      Metropolitan Research, Fairfax,  Virginia,  22031,  United States; Recruiting
Vinod K. Rustgi, M.D.,  Principal Investigator


      Inova Fairfax Hospital, Annandale,  Virginia,  22003,  United States; Recruiting
Zobair M. Younossi, M.D., MPH,  Principal Investigator


Puerto Rico
      Fundacion de Investigacion de Diego, Santurce,  00909,  Puerto Rico; Recruiting
Maribel Rodriguez-Torres, M.D.,  Principal Investigator



Study chairs or principal investigators

Medical Monitor,  Study Director,  Vertex Pharmaceuticals Incorporated

[FlGuy]

I don't know what the 'usual' is for theses trials, I'm kind of new to the research for trials myself.  I'm heading to the docs that come under 'Miami' which is the hepatology gang at the Univ of Miami.  My appt is on 8/11 and I'll ask about what the plan is for non-geno 1 relapsers - which is basically the intent of the appointment.  When I get back from the appt I'll post anything that I learn.  Right now, based on phone conversations, it sounds like they may get to relapsers early in 2007.

[GrandOak]

I hear ya.  I've been contemplating making an investment myself giving the good reports on VX950 so far.  When FDA approved I have a feeling stock will soar.  Currently holding mainly Merck and Wyeth in IRA as main pharmacuticals.

[Forseegood]

Hi Kalio, ha ha, rub it in! I know youre on the coast at least enjoying the ocean breezes if not the ocean itself!...(I don't know if I mentioned that a friend of mine told me that he had riba rash that was horrible, and it was only mildly helped by the different creams. His doc told him that ocean water was great for rashes, and dang if that didn't prove to be true for him! He went in almost every morning before work (lives in Santa Monica). Maybe get in there early in the morning before the sun beats down, just a thought...I know not everyone enjoys cold water, but it's been so hot enough, God knows, and the Pacific water is relatively warm...ever been in the Atlantic? brrrr!!!!

Yeah, haven't been posting a lot, but I continue to read from time to time, and I'm cheering ALL you guys on from the sidelines still...I read that post where you and Fisheress had to have all those taps and meningitis, it really broke my heart...I'm sooooo hoping that all you guys clear, you've been through so much....I hope we all clear!!!!

Well, all this beach talk has got me thinking about a drive to the coast myself today, (day off) it's only going to be in the mid-80's today, that's an arctic blast compared to what's been going on! ha ha! Thank God and all his wisdom for Air Conditioning huh? I got two blasting (sorry, I wish I could be more energy conservative here, but it's every man for himself in this heat, ha ha!) and I have my room air filters going...The best to you Kalio, I'm cheering you on!!!!!

[miked]

Thanks.  Let us know.

[Forseegood]

hi, been wondering about you!!!! glad things are proceeding at a brisk pace for you! I would love to talk to you about our experiences on this, please contact me at Janis and Friends, (just put in a search for me and then you'll get my profile with email) as there is no way to post emails here, don't worry, I'm not a stalker, ha ha! We could have one correspondence about it and that'll be it, (if you'd like) I respect people's privacy....if not, I respect your wishes whatever they are and I'll continue to read your updates here, hoping you have the best outcome with all of this!

[couldn't think of a nickname]

Mike, Sorry, I don't know anything about that, and the non-responder part of the trial is not finalized. They are calling it Prove 3. But, this is also an area I don't know much about.

GO, wrt to the stock, part of the reason for the drop IMHO (and I do work in this area) was probably related to the pushout of VX-702-meaning the next trial not starting soon as was expected, but now early next year. Same thing with the HIV PI Brecanavir, but probably a much smaller effect, as they would only get royalties from that as they decided to collaborate with Glaxo, and this is on their clock, not VRTX's.

[prettydamscared]

Hi, It's good to hear from you.  I've also been wondering about how you're doing and believe me, I know you're not a stalker.  lol  I have been so busy lately, I haven't had much time to keep uo with the boards.  I'm sure I will be soon because my results were positive and I just learned this a.m. that I'm in.  Woo hoo! at least i think that deserves a woo hoo.  I'm hoping and praying i get into an arm that't 24 or better yet, 12 weeks. How about you, are you still considering treatment and are the trials still a consideration? Aren't you 1A?

Hubby is 11 of 24 and while he doesn't have any really bad sides, his energy level is very low.  He's not a complainer at all (unlike me, I'm such a big baby) so I really don't even know half the time how he's feeling but he did tell me yesterday that he wants to be prescribed Procrit.  I don't think that's possible cuz his levels are barely below normal.  He's just kinda clueless about the disease, the treatment, all of it.  Kind of unbelieveable to me because I'm so opposite.  I wanna know AMAP since I have it and am going to be treated.  But each to his own, right?  But, it is really kinda cool that he is running a very time consuming business here and recently started another business in New Orleans...he's a contractor.  Flying back and forth every 2 weeks and not missing a beat.  No rashes, doesn't seem to have any brain fog.  Really tired and flu like feeling day after shot and feels drained much more than usual but for him it seems do-able. Actually he described the day after shot feeling once as feeling very hung over.  Anyway, it's kinda positive for me to see that while it's not easy, for him anyway, it's not killing him either, so far.... Oh and did I mention he was undectible at 4 weeks. Some people are so lucky...

I'm rushing around to get ready to go out of town right now.  When I return I'm gonna look you up on Janus.  I'm so glad you responded - I have so many things I wanna ask you and tell you.  Have a great weekend and I look forward to talking to you next week. (Boy, this board really moves fast, doesn't it... I just hope you find this.)
Talk to you soon, Char

[Forseegood]

hey, I found you!!!! good for you woman! we're all watching you trailblazers, ha ha! Please, do contact me...yeah, I'm on here sometimes, and sometimes not, so do email me...It's funny about certain people, they don't let on how bad they are feeling, and then they drop an anvil on your foot! (so to speak) I hope your hubby feels better soon, sure youre telling him to take it easy, he's on some strong meds and it's important that he treats himself as if he were a bit more fragile then usual, don't want him to compound the problems he's having (I'm SUCH a budinsky, please forgive me, I mean well, ha ha) yeah, we'll trade stories, I'd like some different takes on this Vertex...be well....talk to you soon, whenever it's convenient...