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Celiac.com 06/11/2019 - A potentially major breakthrough in celiac disease treatment owes at least part of its success to a simple drive-in hamburger from Seattle's beloved and legendary Dick's Drive-In. If you have celiac disease, and haven't heard of PvP Biologics, you likely will. PvP originated in 2011 as an award winning student biology project at the University of Washington Institute for Protein Design, a lab that has created several successful startups. PvP's enzyme-driven product, KumaMax, is designed to break down gliadin, the part of gluten that triggers an autoimmune reaction in people with celiac disease and gluten sensitivity. Like most similar enzyme therapies, KumaMax is not designed to be a cure for celiac disease, but to help prevent adverse reactions from accidental gluten contamination. KumaMax is designed to break down gluten in the stomach, and to help prevent a gluten reaction. Celiac.com covered part of the PvP story in 2017 in our article "Takeda Taps PvP Biologics to Develop Celiac Disease Therapy." That story covered PvP's deal with Japanese drug giant Takeda, which gave the startup $35 million to complete a phase 1 clinical trial, at which point Takeda has the option to purchase the startup. Apparently, when it was time for PvP Biologics to test KumaMax, the research team needed to make sure their enzyme would work in the stomach, and work only against gluten proteins, not against meat or dairy proteins. The team wanted a meal that would allow them to test the gluten-neutralizing properties of their drug in conditions that mimicked the human stomach. For that meal, the team turned to Dick's Drive-In, purveyors of fine burgers. “We got a hamburger and a vanilla milkshake from the Dick’s Drive-In in Wallingford,” said Ingrid Pultz, co-founder and chief scientific officer of PvP. “If we were going to get a hamburger, it might as well be from Dick’s. It’s a Seattle institution.” Team members labeled the food as lab equipment. They then blended and acidified the mixture, to mimic the stomach environment, and added the KumaMax enzyme. The enzyme worked well enough to become PvP's lead molecule, and to earn the support of Takeda. So there you have it. KumaMax, the breakthrough gluten dissolving enzyme that may offer celiacs some protection against accidental gluten ingestion has its roots in a simple hamburger and milkshake from Seattle institution, Dick's Drive-In. Read more at Geekwire.com
Celiac.com 12/14/2017 - Can enzyme supplements help people with gluten sensitivity, including those with celiac disease? An Australian company is touting the results of a recent randomized, double blind study that supports enzyme supplements might be helpful for celiac patients in certain circumstances. The enzyme supplement was designed for people with celiac disease to use when facing likely or possible exposure to gluten, such as when traveling or eating food prepared outside their direct control. The company is careful to state that "enzyme supplementation won't cure celiac disease, and sufferers still need to avoid gluten." But the evidence from the two most recent studies does suggest that the product does help digest dietary gluten and could make life much easier for many people with celiac disease. The product, called GluteGuard, is based on a papaya fruit enzyme called caricain. This enzyme is shown to be helpful for celiac patients. A 2015 study showed adding caricain to bread dough reduced gluten toxicity to gluten by 90% for celiac patients. GluteGuard was recently evaluated in two clinical studies in Poland. The first study looked at 20 patients with celiac disease who were in clinical remission on a gluten-free diet. In that study, all patients ate one gram of gluten, equal to about one slice of bread, each day for 42 days, with 14 patients also taking GluteGuard and six taking a placebo tablet. Patients noted their symptoms and well-being each day, and received biopsies both before and after the study. Thirteen of the 14 celiac patients (93%) taking GluteGuard showed no adverse changes in clinical symptoms, biopsy results or well-being throughout the 42 day trial. Only one GluteGuard patient withdrew due to celiac-associated symptoms, while 4 of 6 taking placebo withdrew after 14 days due to adverse celiac symptoms. The second Polish study looked at the effectiveness of GluteGuard in patients with dermatitis herpetiformis, a gluten-triggered skin condition common in celiac patients. As with the first study, all patients in these study were in clinical remission. Patients consumed around six grams of gluten daily for seven days, with ten patients also receiving GluteGuard tablets and ten getting a placebo. The GluteGuard showed better results compared with the placebo group, with 81% showing no increase in areas of skin lesions and 71% showing a reduction in the appearance of skin lesions. The GluteGuard group also showed a 38% reduction in skin itchiness. Of the seven patients who withdrew from the study due to gluten symptoms, six were taking placebo. Both clinical trials met high scientific standards. In both studies, participants were randomly allocated to receive the treatment or placebo, and neither the participants nor the researchers knew owhich patient was receiving which intervention. So, yes, enzyme supplements may provide some help for people with celiac disease, especially as a hedge against minor or occasional gluten ingestion. So far though, they are not a magic bullet, and cannot replace a gluten-free diet. Read more at Medicalexpress.com.
Celiac.com 06/02/2002 Prepared by Laura Yick - There are currently two bills in congress regarding food labeling that affect people with celiac disease. Both HR 1356 and HR 4704 were introduced by Representative Nita M. Lowey (D-NY) in the House of Representatives. S 2499 is the same as HR 4704 and was introduced by Senator Edward M. Kennedy (D-MA) in the Senate. It appears that HR 1356 is somewhat conflicting with HR 4704 and is a weaker version with less detail. HR 4704/S 2499 bill looks to be more beneficial for us (we all know the frustrations of having to verify the gluten status of foods, even if they are labeled gluten-free!), as it contains a section that deals with cross-contamination (see p.9 lines 13-25, p.10, and p.11 lines 1-2). HR 4704/S 2499 is under the control of the Secretary of Health and Human Services, however, the enforcement of cross-contamination labeling is not clear. You can compare them for yourself by going to the US Congress websites listed below. Here is a summary of each bill and a listing of the committee and subcommittee members who have control over the fate of the bills: House Bill H.R.1356 Sponsor: Rep Lowey, Nita M.(introduced 4/3/2001) Title: To amend the Federal Food, Drug, and Cosmetic Act to require that foods containing spices, flavoring, or coloring derived from meat, poultry, other animal products (including insects), or known allergens bear labeling stating that fact and their names. SUMMARY AS OF: 4/3/2001--Introduced. Food Ingredient Right to Know Act Amends the Federal Food, Drug, and Cosmetic Act to provide that a food shall be deemed to be misbranded if it contains any spice, flavoring, or coloring derived from meat, poultry, any other animal product (including insects), or a known food allergen unless its labeling bears a statement with appropriate prominence on the information panel providing that fact and the name of the meat, poultry, other animal product, or known food allergen. STATUS: 4/3/2001: Referred to the House Committee on Energy and Commerce (see below for list of committee members). 4/25/2001: Referred to the Subcommittee on Health (see below for list of subcommittee members). 07/29/2002: The food Allergen Bill S.2499 has been rescheduled for discussion after the August recess. House Bill H.R.4704 Sponsor: Rep Lowey, Nita M.(introduced 5/9/2002) Title: To amend the Federal Food, Drug, and Cosmetic Act to establish labeling requirements regarding allergenic substances in food, and for other purposes. STATUS: (color indicates Senate actions) 5/9/2002: Referred to the House Committee on Energy and Commerce. 5/17/2002: Referred to the Subcommittee on Health. Senate Bill S.2499 Sponsor: Sen. Kennedy, Edward M.(introduced 5/9/2002) Title: A Bill to amend the Federal Food, Drug, and Cosmetic Act to establish labeling requirements regarding allergenic substances in food, and for other purposes. STATUS: 5/9/2002: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. The current laws of the United States can be found at: http://law2.house.gov/download.htm Note that HR 4704 and S 2499 have exactly the same wording except for the sponsors. Bills in committees or subcommittees have three fates: (1) Tabled (i.e., they are essentially postponed, possibly forever), (2) Releasing it for a full House or Senate vote with a recommendation to pass it, (3) Revised and then released as in (2). Bills in committees also may be referred to subcommittees within the committee. It is possible that the Senate Committee on Health, Education, Labor, and Pensions may refer S 2499 to the Subcommittee on Public Health. The bill needs to pass with a simple majority (218 of 435 in the House, 26 of 50 in the Senate). The bill then goes to the other congressional body where the process begins again. Once both the House and Senate pass the bill, any differences between the House version and Senate version must be worked out by a conference committee of both House and Senate members. Then the bill must finally be approved by both the House and Senate. Because HR 4704 and S 2499 are concurrent, the entire process may be faster than if only one body of Congress were working on it. Finally, the President needs to approve it; otherwise, the bill goes back to the House and Senate and must pass by a 2/3 majority in both. If your representative or senator is listed below on a committee and/or subcommittee that is reviewing a bill, it is important that you request them to speed the committee recommendation of the bill to the full House or Senate vote and to ensure that it is not weakened. If your representative or senator is not on one of the committees or subcommittees, you could still urge them to support the speedy passage of the bills. Speedy passage is essential because there is a clause that gives a four year grace period. Politically, it may be especially effective for you to write your congress people regarding these bills if they are up for re-election, or if they are seeking higher office in an upcoming election, but any e-mail to your representatives will be helpful. To see who your representative is: http://www.house.gov/house/MemberWWW.html To write your representative: http://www.house.gov/writerep/ To see who your senators are: http://www.senate.gov/senators/senator_by_state.cfm To write your senators: http://www.senate.gov/contacting/index.cfm Tips from the GIG on writing your letters or e-mails: Address the Congressman as Honorable. Keep the letter to one page. Stay on the message - The passage of Representative Lowey and Senator Kennedy Bill, the Food Allergen Consumer Protection Act is important to the health and safety of thousands of persons suffering from allergies and intolerances. Use the language used in the Bill ...gluten and allergens, not celiac disease. Tell them what you want -- for them to support passage of this Bill. Sharing a bad experience and how passage of this bill would have made a difference can be helpful...but keep it brief. Remind them you follow their votes and that you appreciate their support. Sign your name, provide your full address, and phone number. The names of Subcommittee and Committee Members who control the fate of these bills. We can make a difference with our letters and e-mail to them: The current House Committee on Energy and Commerce: W. J. Billy Tauzin, Chairman Michael Bilirakis, Florida Joe Barton, Texas Fred Upton, Michigan Cliff Stearns, Florida Paul E. Gillmor, Ohio James C. Greenwood, Pennsylvania Christopher Cox, California Nathan Deal, Georgia Richard Burr, North Carolina, Vice Chairman Ed Whitfield, Kentucky Greg Ganske, Iowa Charlie Norwood, Georgia Barbara Cubin, Wyoming John Shimkus, Illinois Heather Wilson, New Mexico John B. Shadegg, Arizona Charles Chip Pickering, Mississippi Vito Fossella, New York Roy Blunt, Missouri Thomas Davis, Virginia Ed Bryant, Tennessee Robert Ehrlich, Maryland Steve Buyer, Indiana George Radanovich, California Charles F. Bass, New Hampshire Joseph Pitts, Pennsylvania Mary Bono, California Greg Walden, Oregon Lee Terry, Nebraska Ernie Fletcher, Kentucky John D. Dingell, Michigan, Ranking Member Henry A. Waxman, California Edward J. Markey, Massachusetts Ralph M. Hall, Texas Rick Boucher, Virginia Edolphus Towns, New York Frank Pallone Jr., New Jersey Sherrod Brown, Ohio Bart Gordon, Tennessee Peter Deutsch, Florida Bobby L. Rush, Illinois Anna G. Eshoo, California Bart Stupak, Michigan Eliot L. Engel, New York Tom Sawyer, Ohio Albert R. Wynn, Maryland Gene Green, Texas Karen McCarthy, Missouri Ted Strickland, Ohio Diana DeGette, Colorado Tom Barrett, Wisconsin Bill Luther, Minnesota Lois Capps, California Mike Doyle, Pennsylvania Chris John, Louisiana Jane Harman, California House Committee on Energy and Commerce Subcommittee on Health: Michael Bilirakis, Florida, Chairman Joe Barton, Texas Fred Upton, Michigan James C. Greenwood, Pennsylvania Nathan Deal, Georgia Richard Burr, North Carolina Ed Whitfield, Kentucky Greg Ganske, Iowa Charlie Norwood, Georgia, Vice Chairman Barbara Cubin, Wyoming Heather Wilson, New Mexico John B. Shadegg, Arizona Charles W. Chip Pickering, Mississippi Ed Bryant, Tennessee Robert L. Ehrlich, Jr., Maryland Steve Buyer, Indiana Joseph R. Pitts, Pennsylvania W.J. Billy Tauzin, Louisiana Sherrod Brown, Ohio, Ranking Member Henry A. Waxman, California Ted Strickland, Ohio Tom Barrett, Wisconsin Lois Capps, California Ralph M. Hall, Texas Edolphus Towns, New York Frank Pallone, Jr., New Jersey Peter Deutsch, Florida Anna G. Eshoo, California Bart Stupak, Michigan Eliot L. Engel, New York Albert R. Wynn, Maryland Gene Green, Texas John D. Dingell, Michigan Senate Committee on Health, Education, Labor, and Pensions: Edward M. Kennedy, MA, Chairman Christopher Dodd, CT Tom Harkin, IA Barbara Mikulski, MD James Jeffords, VT Jeff Bingaman, NM Paul Wellstone, MN Patty Murray, WA Jack Reed, RI John Edwards, NC Hillary Clinton, NY Judd Gregg, NH, Ranking Member Bill Frist, TN Mike Enzi, WY Tim Hutchinson, AR John Warner, VA Christopher Bond, MO Pat Roberts, KS Susan Collins, ME Jeff Sessions, AL Mike DeWine, OH Senate Committee on Health, Education, Labor, and Pensions Subcommittee on Public Health: Edward M. Kennedy, MA, Chairman Tom Harkin, IA Barbara Mikulski, MD James Jeffords, VT Jeff Bingaman, NM Paul Wellstone, MN Jack Reed, RI John Edwards, NC Hillary Clinton, NY Judd Gregg, NH, Bill Frist, TN Michael Enzi, WY Tim Hutchinson, AR Christopher Bond, MO Pat Roberts, KS Susan Collins, ME Jeff Sessions, AL