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Health Canada grants ViaCyte clearance for diabetes clinical trial

Discussion in 'Research' started by Ellen, Jan 10, 2015.

  1. Ellen

    Ellen Senior Member

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    http://www.healio.com/endocrinology...viacyte-clearance-for-diabetes-clinical-trial

    Health Canada has issued a No Objection Letter to ViaCyte, Inc., giving the company the go-ahead to proceed with sites in Canada for is Phase 1/2 clinical trial of VC-01 product candidate, according to a company press release.

    Patients with type 1 diabetes who have minimal to no insulin-producing beta-cell function are being evaluated for the VC-01 product candidate.
    “The first cohort of patients in this two-cohort dose escalation study of the VC-01 product candidate is currently being assessed at a single site in the United States,” Paul Laikind, PhD, preside and CEO of ViaCyte, said in a press release. “Should the product candidate proceed to the second cohort, we intend to expand the trial to multiple sites. Health Canada’s approval represents further validation of the trial and allows us to expand internationally to one or more sites in Canada.”
    The FDA granted the investigational new drug application for the trial, called STEP ONE, and the study launched in September 2014 at the University of California San Diego Health System.
    The trial will evaluate the effectiveness of the product candidate in replacing lost endocrine function. Forty participants are expected to be enrolled in the trial.


    http://viacyte.com/press-releases/viacyte-receives-clearance-from-health-canada-for-diabetes-clinical-trial/

    [h=2]ViaCyte Receives Clearance from Health Canada for Diabetes Clinical Trial[/h]San Diego, January 8, 2015 — ViaCyte, Inc., a privately-held regenerative medicine company with the first stem cell-derived islet replacement therapy for the treatment of diabetes in clinical trials, has received a No Objection Letter from Health Canada providing clearance to proceed with sites in Canada for the Company’s Phase 1/2 clinical trial of its VC-01[SUP]TM[/SUP] product candidate. The VC-01 product candidate is currently being evaluated in patients with type 1 diabetes who have minimal to no insulin-producing beta cell function. The location and enrollment start date of the first Canadian clinical trial site have not yet been disclosed.
    “The first cohort of patients in this two-cohort dose escalation study of the VC-01 product candidate is currently being assessed at a single site in the United States. Should the product candidate proceed to the second cohort, we intend to expand the trial to multiple sites,” said Paul Laikind, PhD, President and CEO of ViaCyte. “Health Canada’s approval represents further validation of the trial and allows us to expand internationally to one or more sites in Canada.”
    The Investigational New Drug application for the Phase 1/2 trial, called STEP ONE, or Safety, Tolerability, and Efficacy of VC-01 Combination Product in Type 1, was allowed by the US Food and Drug Administration in August 2014. The STEP ONE trial was launched in September 2014 at UC San Diego Health System, with the support of the UC San Diego Sanford Stem Cell Clinical Center and under the direction of Principal Investigator Robert Henry, MD. The first implant was performed in October 2014.
    In addition to determining the safety of the product candidate in these patients, STEP ONE is designed to evaluate the effectiveness of the VC-01 product candidate in replacing the lost endocrine function that is central to the disease. In an open-label, dose-escalating format, ViaCyte expects to enroll approximately 40 patients in the study at multiple clinical sites.
    About ViaCyte
    ViaCyte is a privately-held, clinical-stage regenerative medicine company focused on developing a novel cell therapy for the treatment of diabetes. ViaCyte is conducting a Phase 1/2 clinical trial, called STEP ONE, of the Company’s lead product candidate VC-01 in patients with type 1 diabetes who have minimal to no insulin-producing beta cell function. The VC-01 combination product is based on the production of pancreatic progenitor cells (PEC-01™ cells), which are implanted in a durable and retrievable encapsulation device, known as the Encaptra[SUP]®[/SUP] drug delivery system. Once implanted and matured, these cells are designed to secrete insulin and other regulatory factors in response to blood glucose levels. The VC-01 combination product is being developed as a potential long-term diabetes treatment without immune suppression and without risk of hypoglycemia or other diabetes-related complications.
    ViaCyte is headquartered in San Diego, California with additional operations in Athens, Georgia. The Company is funded in part by the California Institute for Regenerative Medicine and JDRF. For more information, please visitwww.viacyte.com.

    ViaCyte Media Contacts:
    Paul Laikind, PhD
    President and Chief Executive Officer
    ViaCyte, Inc.
    +1-858-455-3708
    plaikind@viacyte.com
    Jessica Yingling, PhD
    Little Dog Communications, Inc.
    +1-858-344-8091
    jessica@litldog.com
    ViaCyte Investor Relations:
    Lisa Wilson
    In-Site Communications, Inc.\
    +1-917-543-9932
    lwilson@insitecony.com



     
  2. hopefull340

    hopefull340 Approved members

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    My understanding is in the first patient did not get good results/bg control So they removed it and Viacyte is trying another location small intestine?Did you hear anything on location of implant? Thanks to the willingness of this one individual they literally shaved off 10 yrs jumping from lab to human trials Bless him for that! Michelle
     
  3. sszyszkiewicz

    sszyszkiewicz Approved members

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    Where did you hear that?
     
  4. Mkampmann25

    Mkampmann25 New Member

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    If you look at diabetes mine, Viacyte just gave a presentation althought did not present results of this particular trial at the JP Morgan Health Care Conference. Paul Laikind, their CEO, said they just implanted their third patient in the clinical trial. So unless the patient herself/himself said something, Viacyte is not giving out results yet.
     
  5. hopefull340

    hopefull340 Approved members

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    It was a youtube video on the very first patient Im going to try to find the link, he shaved years off their research by subjecting himself as a patient but something happened and they put it in another location this was an interview with the patient .I haven't heard any news on the other patients. The comment he said was ....that the inplant was going to be trialed in a different location the small intestine? Im going to try to find the link again. They are being backed by Jdrf, and Johnson and Johnson so for a small company with Large potential this is good news.
     
  6. Christopher

    Christopher Approved members

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    Granted, I don't know all the details but that is not the way real research normally works. You can't take shortcuts.
     
    Last edited: Jan 29, 2015
  7. Ellen

    Ellen Senior Member

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    Recruiting in San Diego
    https://clinicaltrials.gov/ct2/show/NCT02239354

    [TABLE="class: layout_table indent2"]
    [TR]
    [TD]University of California at San Diego[/TD]
    [TD="class: header3"]Recruiting[/TD]
    [/TR]
    [TR]
    [TD="colspan: 2"]San Diego, California, United States[/TD]
    [/TR]
    [TR]
    [TD="colspan: 2"]Contact: Study Coordinator tmay@ucsd.edu[/TD]
    [/TR]
    [/TABLE]

    "The purpose of this trial is to test if VC-01™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and maintained safely for two years. It will also test if VC-01 is an effective treatment for subjects with Type 1 Diabetes."
     
  8. hopefull340

    hopefull340 Approved members

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    Viacyte Update Study Update
    Exciting study update....everyday we are closer! An update on the ongoing Viacyte islet cell encapsulation trial at UCSD. As a background on the study, it involves implantation of islet stem cells placed in a special encapsulation device into patients with type 1 diabetes. These stem cells are capable of dividing into not only beta cells that make insulin, but also alpha cells that make glucagon. The device that holds the cells is specially engineered to allow glucose and insulin in and out, but does not allow immune cells in. This is particularly important because the cells can then sense glucose and release insulin, but patients do NOT need to take immunosuppressive medications. The idea is, that with these devices in place, they would essentially start acting like a “normal” pancreas and restore glucose control while being protected from immune destruction. We are implanting the devices into the patients’ low back area to kind of keep them out of the way of insulin pumps, CGMs, needles, etc. In this first group of very brave patients, we are learning a great deal about the surgical procedure and the “best” way to implant these devices. UCSD is the only site involved so far, and we have successfully implanted 3 patients with the devices with a 4th tentatively scheduled in a couple weeks. The primary goal of the study is to demonstrate SAFETY with subsequent studies looking more into efficacy. We will likely implant 6 patients in this first cohort to look, again, mostly at safety before moving to the next cohort that will receive more of the devices. This second cohort will include additional sites beyond UCSD- likely 5-6 sites throughout the US and Canada. There has been a lot of excitement and hope surrounding this trial, so I just wanted to report that things are proceeding as planned so far. Everybody wants to know how these patients are doing in terms of insulin requirements etc, but it is far far too early to discuss this- keeping in mind, again, that we are just making sure the surgery and procedure are feasible and safe at this point. Stay tuned! For more information about the study, go to www.viacyte.com All very exciting, and just wanted to share ! Check out their websites .. & Chris No it isn't But
    They are following Canadian health protocol ...and Have furthered Their research to the next level Looking good for Viacye!
     
  9. Parody

    Parody Approved members

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  10. KnowledgeisPower

    KnowledgeisPower New Member

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    Hopefull for a response

    Can you please provide a link?
     
  11. rgcainmd

    rgcainmd Approved members

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    Chris is correct. It would be helpful to read up on basic research methodology, statistical analysis, trial results, and real-life applicability of those results to the affected gen pop. Pay particular attention to The Big N (sample size).
     

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