AlloCure, With Stem Cell Therapy for Kidney Failure, Arrives in New England with New CEO

7/6/10Follow @xconomy

Boston has landed an intriguing biotech startup seeking to tap the New England talent pool. AlloCure, the developer of an adult stem cell therapy for a severe kidney disease, has moved its headquarters from Salt Lake City to Burlington, MA, where it is being led by new CEO Robert Brenner, a veteran executive from AMAG Pharmaceuticals and Amgen.

AlloCure first made news in July 2008, when it nailed down an initial financing of $14.5 million from SV Life Sciences and the venture arm of Danish drug giant Novo Nordisk. This company is still quite lean, with less than 10 employees, but it has global operations with sites in Utah and Hamburg, Germany, where its respective co-founders, Christoph Westenfelder and Axel Zander, are located. Brenner, the new CEO, will be based in Burlington, MA.

The big idea at AlloCure is to come up with an adult stem cell therapy that could be the first effective treatment for acute kidney injury, also sometimes called acute renal failure. This is a condition in which people’s kidneys quit working, and the only real treatments are dialysis or a kidney transplant. People with diabetes or high blood pressure are often at high risk of getting an acute kidney injury in the hospital if they go on a heart bypass machine during surgery, or get certain potent antibiotics, Brenner says. Estimates vary, but as many as 500,000 people in the U.S. suffer from this condition, and various studies put the death rate at 30 to 70 percent within a year’s time of the injury, Brenner says.

“If we could develop a cell therapy for acute kidney injury, it would be a revolution,” Brenner says. “People have been working on this for their entire professional careers.”

Lots of novel ideas have been tried, and all of them have failed. Researchers in the past have experimented with an injectable peptide from Scios, a unit of Johnson & Johnson, as well as Amgen’s blockbuster anemia drug, erythropoietin (Epogen), and a variety of devices.

Robert Brenner

Robert Brenner

The founders of AlloCure have a different strategy that hinges on an infusion of adult stem cells that might be able to prevent acute kidney injury from happening, or help reverse the damage in the early stages, Brenner says. AlloCure’s founders have learned how to take a certain kind of adult stem cell found in the bone marrow, called mesenchymal stem cells, and greatly expand their numbers in a consistent manufacturing procedure. Importantly, they’ve shown they can isolate cells without certain markers on the surface, known as antigens, that could provoke the patient’s immune system to recognize the cells as foreign invaders that must be attacked. This means that cells from any individual could be grown in an AlloCure factory, and infused into any patient, without requiring a genetic match, Brenner says.

Because the infusion would be standardized, it’s possible the cells could be kept in stock at hospitals and given “off-the-shelf” when a kidney specialist sees signs of acute kidney injury.

AlloCure hasn’t publicly disclosed any clinical trial results yet on this procedure, but it enticed Brenner to join the company based on results of a study of 16 patients. This study was designed to give patients a single high-dose infusion of these mesenchymal stem cells after they underwent surgery which put them on a heart bypass machine. While patients weren’t randomly assigned to a control group to offer a strong comparative benchmark, researchers did follow other patients who got similar surgeries without the cell therapy infusion, Brenner says. That offered an eye-opening contrast, he says. The results will be presented at an upcoming medical meeting and published in a peer-reviewed journal, Brenner says.

“The results are extremely promising,” he says.

Brenner, 42, doesn’t need to hire a consultant to tell him the difference between good and mediocre data. He’s a medical doctor himself, who did his residency at Brigham & Women’s Hospital in Boston, and a fellowship in nephrology (the study of kidney function) at Stanford University Medical Center. Brenner spent nine years of his career at Thousand Oaks, CA-based Amgen (NASDAQ: AMGN), ending his tenure there in 2008 as executive director of its renal anemia global program. He endured the worst year in the company’s history, 2007, as Amgen was besieged with safety warnings about its anemia drugs for both kidney and cancer patients. After Amgen, he moved up to senior vice president of medical affairs for Lexington, MA-based AMAG Pharmaceuticals, where he was involved in the rollout of that company’s drug for kidney patients, ferumoxytol (Feraheme).

AlloCure, under its new CEO, is now mapping out a course to prove that its therapy really works in a more rigorous mid-stage clinical trial. The company is working on the design of a Phase II trial that will randomly assign patients to get its cell therapy infusion, or something else in a control group. The company is considering different doses and timing for the infusion, to establish whether it can prevent acute kidney injury or help reverse the course of disease once it’s caught in the early stages, Brenner says.

The company has to meet with the FDA to talk about his clinical trial game plan, with hopes of getting the trial going in 2011, Brenner says. AlloCure should have enough money to get the mid-stage trial started, but at some point it will need to consider more financing, from venture capitalists or other sources, he says.

These are, of course, still very early days for AlloCure. Plenty could go wrong in further trials, and the therapy might not work, Brenner says. But if it does, the potential impact for medicine is big. Plenty of companies are testing adult stem cell infusions for various ailments, but no others are pursuing this mode of treatment for acute kidney injury, Brenner says.

“If we can develop a robust treatment, it would be remarkable,” Brenner says. “The benefits to patients and society would be tremendous.”

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  • christine monroe

    I was diagnosed with IGA Nephrophathy Also known as (bergers disease) in Jan. of 08. I am in stage 3. I would like to be considered for stem cell research of my kidneys. Please keep me informed and consider me for future trials. Thank you in advance. Chris Monroe

  • Pavan Goutham

    I was diagonsed with IGA Nephropathy > than 50% chronicity in march 2010. Right now my creatinine is about 8.0 and i am undergoing dialysis thrice a week. I would like to consider myself for stem cell research of my kidneys. Pls keep me informed about the pros and cons of this therapy and its cost. Thanks in anticipation. Pavan Goutham, Bangalore, India.

  • purvi yadav

    i was diagnosed with IGA NEPHROPATHY in jan 2010 .my present creatinine is 5.16.i want to opt for stem cell therapy…..please andvise

  • amanda mott

    Hey, I really hope this helps. My dads side of the family has a genetic kidney disease that’s in medical research. Wake forest been working on a cure….. I too have this chronic illness, my 20 year old cousin with two kids is on a transplant list….. my other cousin 19 has it. All females have it this generation…. skipped the males. I was diagnosed at 15, doctors in cleveland clinic want me to keep my kidneys. Function is about 40% if you don’t mind keep me updated and if I can be used for a trial ill be more then happy too…… thank you

  • nesrin yeşil

    hello to you from Turkey I’m getting dialysis have kidney failure. I want to be treated with stem cells. Is it possible to help me, please

  • William

    I was diagonsed with IGA Nephropathy three years ago, would like to learn more about this treatment.

  • http://None Manish

    Hi,

    I was diagnosed with IGA Nephrophathy Nov. of 2010. I am in stage 4. I would like to be considered for stem cell research of my kidneys. Please keep me informed and consider me for future trials. Thank you in advance.

    Manish

  • Cuong Quach

    I have been treated for IGA nephropathy at Lahey Clinic Burlington for the past twelve years. I started my dialysis since Jan 2011 with a creatine of 10. Please consider me with your stem cell research

  • Sumit

    please tell me how i recover from kidney failure. i am afraid of dialysis so please tell me other option which can recover for long time

  • http://www.shabakajobber.wetpaint.com NABIL SHABAKA

    Dear sirs, my wife is suffering from kidney failure from 7 years & uses 3 times weekly dialysis — PLS tell me about using your remarkable stem cells therapy — we are in EGYPT —- THANkS & BEST REGARDS TO Dr. Brennerand and for all,
    Nabil Shabaka
    Cultural Consultant

  • Thomas

    I recently had an operation that went badly on a perianal abcess. I went septic and my kidneys failed. Now I do dialysis 3X a week. My creatine is 4.8. I have no other diseases other than the acute renal failure. My wife and I live within commuting distance to Burlington. I might be an ideal candidate for your stem cell research on kidney rejuvenation. I have no religious issues. Tom

  • Lorraine

    I have been diagnosed with FSGS and nephrotic syndrome. My creatine level is at 3.6 and rising. I am at stage 4 kindney failure and I am will for any trial that will help. Please contact me if I am a candidate for a trial or if therapy become available.

  • Claudia Sherrick

    Please advise if you are doing any stem cell trails for kidney failure.

  • Ronald Rock

    Interested in being in clinical Trials. I have been on dialysis for 8 years as of May. Many Many more people my age 46, are good and ready for Adult Stem Cell Therapy to began. If the Government is holding you up, we will have a Dialysis million people and families march on D.C. to show them how much we and our Citizens need these Adult Stem Cell kidney treatment. Let me know.

  • Julie

    I am 28 yrs old & was diagnosed with berger’s disease 16 years ago and am now in end stage renal failure 14% function — creatinine 4.6.
    I am taking prednisone but not yet on dialysis and hoping not to. Please consider me for any stem cell or enzyme treatments to avoid transplant. Thank you.

  • Cindy Lee Carleton

    My son was born with Alport’s Syndrome and had a kidney transplant in 2002. At that time his body also began manufacturing a complicated antigen. I found a doctor in Van Couver, Canada who was doing bone marrow transplantation for medical situations similar to this. After speaking to this doctor on the possibilites of doing this procedure to my son I called Dr. Kashtan in Minn. to bounce this off of him. He informed me that no one was doing this possibly dangerous procedure in this country and he felt he was not able to help me convince my son’s doctor to do it either.Now it has been 8 years and I want to know if this research and developement includes already transplanted patients? My son has a kidney from a live donor, so the bone marrow is available. Please let me know.

  • Claudia

    I would like a response to these comments and kept up to date on what you are doing. You got a new CEO, I get it. What is he doing?

  • nesrin yeşil

    Please advise if you are doing any stem cell trails for kidney failure.

  • Ace

    Folks, I realize we all stumbled onto this article because we all want a cure for either ourselves or our loved ones.

    I came across this article because my girlfriend has systemic lupus and a kidney transplant, which is probably going to fail her within a few years. Her creatinine levels are already high enough to be very concerned, so it seems around the corner that things could get a lot worse very quickly.

    But look, writing comments here that you want to volunteer for a clinical trial isn’t going to help you at all. I seriously doubt that Allocure is going to monitor the comments on a 3rd party journalism site, and then reach out to you, especially if they know absolutely nothing about how to contact you.

    So if you really want to pursue this, then visit their site directly: allocure.com

    FWIW, there is also a Chinese outfit using this process with some reported success: http://www.stemcellshezhong.com/

    And there is a medical researcher at Northwestern University that is doing a similar study using donor cells from the kidney donor: http://fsmweb.northwestern.edu/faculty/facultyProfile.cfm?xid=16487

    Best of luck, and try to contact people and companies directly instead of leaving vague messages on the Internet.

  • Claudia

    Thanks Ace for you comments. A bit terse at times but I hope helpful.

  • Ace

    In retrospect, it is terse. I’d just hate for someone to get their hopes up and wonder why they were never contacted.

    There are ongoing clinical trials right now recruiting for this type of treatment, and the US Clinical Trial website can be searched:

    http://clinicaltrials.gov/ct2/results?term=kidney+stem+cell

    Best of luck to everyone – and if anyone wants to watch an inspiring video about whats possible within the next decade:
    http://www.ted.com/talks/anthony_atala_growing_organs_engineering_tissue.html

    Best wishes to all of you.

  • Sam

    St Theresa Hospital in Bangalore offers stem cells treatment for Kidney Disease. Try locating International stem cells services , Bangalore on google and they will give you the cells.
    They have so far treated few hundred patients with mixed results. Those with creatanine around 4 have shown the best improvement.
    Please do your own research and take up with due diligence.

  • Edward Williams

    I was diagnosed with acute kidney failure in 2002, I maintained a fairly stable kidney function using medication until 2008. When I started home dialysis 7 days a week (PD) and have been mostly pleased with the result but obviously I would like a donor kidney or hope for some great advances in stem cell research, I am presently 68 years old and on the national donor list, but as we know that is a long process.
    So if any adult programs come along I would be most willing to participate in any research.

  • robert jones

    i have been diagnosed with CKD this year and my creatinine is 2.96 and my GFR is 26 which puts me at stage 3 almost 4 i would like to be considered for your research. i don’t think i can take dialysis. thank you

  • Jan

    Bioregeneration Integrated Medical Center in Jamaica has worked with many patients with renal failure both within trial settings and outside.They can be contacted at 1-516-345-8205. Kidney patients are still being recruited.

  • thomas hardy

    I have been diagnosed with polycystic kidney disease. I wish to be part of your research. I plan on some type of surgery, hopefully to eliminate or shrink the cysts in my kidneys with stem cell infusion.

  • UBTH Hospital

    We currently have a kidney donor who is willing to donate kidney, if you are interested kindly contact ubthmedicalcentre@yahoo.com for more inquiries +2347054206121