Monday, 23 July 2018

Right to Try (for U.S. patients/advocates)

Hi guys,

I'm wondering if anyone here has pursued the Right to Try law here in the United States? Searching the blog, I couldn't find anything...

My brother is living in Texas where the law has been passed and I've obtained the document provided by the organization website to present to his doctors. (The document is linked here under "How do I initiate a request?" or here is a Google Doc version I uploaded which is the exact same)

James would like to try DCVax-L, if possible.

In order to produce the DCVax-L vaccine, you need to supply fresh or preserved tumor tissue. I've contacted the drug company, Northwest Biotherapeutics https://www.nwbio.com/) and was told:

"In order to manufacture DCVax-L, we usually require 2-3 grams of frozen tumor tissue, although we have worked with less in certain circumstances.  The tissue must be stored frozen without any chemicals or preservatives and not in saline or blocks of paraffin."

 I've confirmed that the tissue from his previous resection has now been transferred to paraffin so is unusable.

James's doctors have already said another resection is not advisable due to the location of his tumor progression. However, assuming we could get a biopsy to have some fresh tissue, I'm wondering if this would be a block for his doctors to go ahead and pursue the Right to Try submission to the drug company.

Would they be likely to submit the document and start the legal process if we don't even have the tissue?

It would seem foolish to do a biopsy if we weren't for sure going to be a candidate for the vaccine.

(Again, I'm unsure if a biopsy is possible at the moment but should find out this week.)

Additionally, I requested more information from NWBio about the Right to Try law and she didn't address it with detail, but just assured me that without tissue, nothing could be done.

Does anyone here have experience with kickstarting this Right to Try process? Any tips or advice would be much appreciated.

Link to my first post outlining James's current condition for context.
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16 comments:

  1. Unknown24 July 2018 at 06:22

    I've been engaged on my wife's behalf, seeking compassionate treatment ('Right to Try') also called expanded access protocol by many research and development medical institutions. You are more than welcome reach out to me via email and I'm glad to share with you what I've discovered: jhicksneal@gmail.com

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    1. Marc24 July 2018 at 16:38

      Jenna,

      Did GW give you a cost for the treatment if you had tumor material correctly available?

      I requested my resected tumor to be saved in the correct manner incase I ever wanted/needed to try the DCVAX.

      Marc

      Delete
    2. jenna24 July 2018 at 17:30

      Thanks for your offer! I will absolutely email you.

      Delete
    3. jenna24 July 2018 at 17:39

      Hi Marc,

      Actually they did NOT give me the cost and were fairly tight-lipped. It's my understanding they've been inundated with patient requests.

      I did read somewhere (thought it was on this blog but now I can't find the information so must've been on a different site) that the cost could easily end up being over 100K. This is due to it being such a custom process.

      The rep did share this with me:

      "Please know, that the Specials program is only available in the UK (London) and James would need to travel to London for a leukaphereis blood draw and for all the injections of vaccine (6 in the first year)".

      I'm also curious about cost but I guess I won't get any real info on that unless we actually petition the company to let James try it. The price will be a deal-breaker for us if it is in the ballpark of 100K.

      Delete
    4. Stephen W24 July 2018 at 23:37

      Jenna, we discussed costs of DCVax in the comments on this post:

      https://btcocktails.blogspot.com/2018/05/dcvax-update.html#comment-form

      Delete
    5. jenna25 July 2018 at 05:06

      Thank you Stephen, that was exactly the comment thread I was referencing!

      Delete
    6. David25 July 2018 at 10:41

      There is a post just below this one discussing vaccine clinics. While DC-Vax is the best, these clinics produce vaccines comparable to those in clinical trials.

      Delete
    7. jenna25 July 2018 at 13:55

      Hi David,

      Yes! I've been spying on that post, too. Thank you for calling it out here in the thread.

      Delete
  2. Guy Lipof24 July 2018 at 16:17

    Hi Jenna,

    Have you gone to MD Anderson for a second opinion/ surgery consult? I know Houston is quite a haul from Dallas. We have been traveling there from Austin for almost 20 years. My wife's original tumor was a no go with neuro-surgeons here in Austin and in San Antonio. MD Anderson's experts didn't break a sweat.

    We do not have experience with Expanded Access or Right to Try. We did discuss the programs in the past; both of my wife's neuro-oncologists (here and at MD Anderson) were supportive. Getting your clinical team aligned is obviously your first hurdle to overcome.

    Best wishes... Guy

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    1. jenna24 July 2018 at 17:33

      Hi Guy,

      We have not considered MD Anderson. Actually, James lives in Amarillo, so the commute to Dallas is starting to get a bit taxing on him (especially now that he's on a stronger does of chemo). The neurosurgeons are supposed to be "top notch" at UT Southwestern and came very highly recommended to us in the beginning. They were our second opinion and we went with them.

      That being said, you do make a good point that I seemed to have overlooked: the second opinion! I can't stress enough how important this was for us in the beginning.

      Thanks for your reply!

      Delete
    2. David26 July 2018 at 22:06

      This is a good trial at MD Anderson and a site in Austin
      https://www.clinicaltrials.gov/ct2/show/NCT02798406

      Delete
    3. jenna27 July 2018 at 17:27

      Thank you, David!

      Delete
  3. SVG25 July 2018 at 01:59

    A DCVaxBrain-type vaccine, strengthened with oncolytic virus is available as approved medicinal product at IOZK, for use in individual treatment approach. IOZK can use Immunogenic cell death-induced antigenic extracellular microvesicles out of the serum for antigenic load of the DCs.
    See also this new publication: http://austinpublishinggroup.com/oncology-case-reports/online-first.php

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    1. jenna25 July 2018 at 05:10

      Thanks, SVG. I've read a bit about IOZK here on this blog but will look into it more - this paper you've linked is published very recently! If anyone reading our comment thread, it would be worth following the link and grabbing the PDF to read.

      Delete
  4. CancerSucks25 July 2018 at 10:47

    It is upsetting to hear that people will not be able to access a therapy because they cannot afford it. I think the Musella Foundation is working to help people obtain DCVax-L through grants and other funding. Please reach out to that organization.

    https://virtualtrials.com/newsarticle.cfm?item=6516

    Good luck to all patients.

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    Replies
    1. jenna25 July 2018 at 16:51

      Thank you, sharpie for this link. I will reach out to Mr. Musella!

      Delete

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