![](http://investorshub.advfn.com/images/default_ih_profile2_4848.jpg?cb=0)
Wednesday, November 04, 2009 8:35:38 AM
8:04a ET November 4, 2009 (GlobeNewswire)
XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced plans to initiate an investigator sponsored Phase 2 clinical trial of XOMA 052, its antibody to interleukin-1 beta (IL-1 beta), in Type 1 diabetes patients. The trial will be sponsored by the Juvenile Diabetes Research Foundation International (JDRF), the largest patient advocacy organization of Type 1 diabetes research worldwide. The trial sponsor is Dr. Marc Donath, Professor of Endocrinology and Diabetes at the University Hospital of Zurich, pioneer in anti-inflammatory approaches to diabetes treatment, and a principal investigator in the Phase 1 studies of XOMA 052. XOMA will provide XOMA 052 drug product for the trial.
The study is designed to evaluate the effect of anti-inflammatory treatment in Type 1 diabetes patients after the initial period of autoimmune activity that results in the loss of blood sugar level control, attempting to prevent the complete loss of beta cells. It follows an initial study indicating that anti-IL-1 drugs may have positive benefit for patients with Type 1 diabetes. The randomized, placebo-controlled study in 24 patients with well-controlled Type 1 diabetes who have had the disease for at least two years will measure the effects of treatment with XOMA 052 over six months on beta cell function and insulin production. The safety, tolerability, and pharmacokinetics of XOMA 052 will also be assessed.
"The evaluation of our general anti-inflammatory drug candidate, XOMA 052, in multiple diseases continues to expand. We are pleased that Dr. Donath plans to initiate a study in Type 1 diabetes with JDRF support. In parallel, XOMA continues to focus on conducting studies of XOMA 052 in patients with Type 2 diabetes and cardiovascular disease," said Steven B. Engle, XOMA's Chairman and Chief Executive Officer. "If successful, this study would be the first showing the impact of reducing inflammation in Type 1 diabetes patients with disease duration of two years or more. It would provide additional evidence of the benefit anti-inflammatory therapy that could lead to the improvement in the lives of many patients."
According to the JDRF, as many as 3 million Americans may have Type 1 diabetes, an autoimmune disease that strikes children and adults suddenly and can be fatal. In Type 1 diabetes, the patient's own immune system destroys the patient's beta cells in their pancreas that normally control blood sugar level. Patients with Type 1 diabetes have to test their blood sugar and give themselves insulin injections multiple times each day, or use a pump every day for the rest of their lives. And even with intensive care, insulin is not a cure for diabetes, nor does it completely prevent its eventual and devastating complications, which may include kidney failure, blindness, heart disease, stroke, and amputation.
IL-1 beta has been demonstrated to be involved in the destruction of pancreatic beta cells in patients with Type 1 diabetes(1) as well as Type 2 disease(2). In Type 1 diabetes, immune cells that target a patient's pancreatic beta cells initiate the damage, which results in an increase in blood glucose levels. The higher blood glucose levels stimulate the production of the pro-inflammatory cytokine IL-1 beta which, in turn, feeds back on the pancreatic beta cells, reducing their insulin-production efficiency and eventually leading to cell death. XOMA 052 is an antibody that binds to IL-1 beta and interferes with the activation of the IL-1 receptor, thereby reducing cellular signaling events that produce pathological levels of inflammation.
"Several clinical studies are ongoing with anti-IL-1 and immune modulating agents in patients at the early stages of Type 1 diabetes, with the objective of preserving beta cell mass," said Dr. Donath. "This trial will test the novel hypothesis that inhibiting the activity of IL-1 beta may prevent ongoing beta cell death at later stages of disease, when most beta cells have been destroyed, and allow beta cell regeneration to prevail and repopulate the pancreas. I am very excited about the potential for an anti-inflammatory treatment for our patients with Type 1 diabetes."
"A key part of JDRF's research is aimed at stopping or reversing the immune system response that causes diabetes: the attack on insulin-secreting cells in the pancreas," said Patricia Kilian, Ph.D., Director of Regeneration at JDRF. "This attack must be stopped so that any therapies involving replacing or regenerating insulin-producing cells can work long-term. We are hopeful that this study will further advance this promising line of research to the benefit of Type 1 diabetes patients."
Recent XOMA News
- XOMA Declares Quarterly Preferred Stock Dividends • GlobeNewswire Inc. • 06/20/2024 11:30:00 AM
- XOMA Receives $8.1 Million Milestone Related to Day One Biopharmaceuticals’ Sale of its Priority Review Voucher • GlobeNewswire Inc. • 06/12/2024 11:30:00 AM
- XOMA to Present at H.C. Wainwright 2nd Annual Bioconnect Investor Conference at NASDAQ • GlobeNewswire Inc. • 05/14/2024 11:30:00 AM
- XOMA Reports First Quarter 2024 Financial Results and Highlights Recent Activities • GlobeNewswire Inc. • 05/09/2024 11:30:00 AM
- XOMA Adds Economic Interests in Three First-in-Category Assets to its Royalty and Milestone Portfolio Including XACIATO™ (clindamycin phosphate) Vaginal Gel 2% • GlobeNewswire Inc. • 04/30/2024 11:30:00 AM
- XOMA Earns $9 Million Milestone as FDA Grants Accelerated Approval to Day One’s OJEMDATM (tovorafenib) for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma (pLGG) • GlobeNewswire Inc. • 04/25/2024 11:30:00 AM
- Actym Therapeutics Appoints Thomas Smart as CEO • PR Newswire (US) • 04/24/2024 01:00:00 PM
- XOMA Corporation Announces Closing of Tender Offer • GlobeNewswire Inc. • 04/03/2024 01:00:00 PM
- XOMA Declares Quarterly Preferred Stock Dividends • GlobeNewswire Inc. • 03/21/2024 11:30:00 AM
- XOMA Announces Calculation of Additional Price Per Share and Extension of Expiration Date for Tender Offer for Kinnate Biopharma Inc. • GlobeNewswire Inc. • 03/19/2024 08:05:00 PM
- XOMA Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent and Upcoming Events Expected to Drive Shareholder Value • GlobeNewswire Inc. • 03/08/2024 12:30:00 PM
- XOMA to Present at Upcoming Investor Conferences in March • GlobeNewswire Inc. • 02/28/2024 12:30:00 PM
- XOMA Enters into Agreement to Acquire Kinnate Biopharma for Between $2.3352 and $2.5879 in Cash Per Share Plus a Contingent Value Right • GlobeNewswire Inc. • 02/16/2024 01:00:00 PM
- XOMA Expands its Commercial Royalty and Milestone Portfolio with DSUVIA® Acquisition • GlobeNewswire Inc. • 01/18/2024 01:30:00 PM
- Xoma to Make $1 Million Milestone Payment to LadRx After FDA Accepts Zevra Application for Arimoclomol • Dow Jones News • 01/11/2024 09:50:00 PM
- FDA Acceptance of Zevra’s Arimoclomol NDA Filing for Niemann-Pick Disease Type C (NPC) Results in XOMA Making a $1 Million Milestone Payment to LadRx • GlobeNewswire Inc. • 01/11/2024 09:05:00 PM
- XOMA Names Owen Hughes as Chief Executive Officer and Appoints Jack L. Wyszomierski as Chairman of the Board of Directors • GlobeNewswire Inc. • 01/08/2024 12:30:00 PM
- XOMA Announces Stock Repurchase Program of up to $50 Million • GlobeNewswire Inc. • 01/02/2024 12:30:00 PM
- XOMA Declares Quarterly Preferred Stock Dividends • GlobeNewswire Inc. • 12/20/2023 12:30:00 PM
- XOMA Raises up to $140 Million in Non-Dilutive, Non-Recourse Financing from Funds Managed by Blue Owl Capital Backed by VABYSMO® Royalties • GlobeNewswire Inc. • 12/19/2023 12:30:00 PM
- XOMA Reports Third Quarter 2023 Financial Results and Highlights Upcoming Events Expected to Drive Shareholder Value • GlobeNewswire Inc. • 11/07/2023 12:30:00 PM
- XOMA Earns $5 Million Milestone Upon FDA Acceptance of Day One’s Tovorafenib NDA for Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG) • GlobeNewswire Inc. • 10/31/2023 11:30:00 AM
- XOMA Declares Quarterly Preferred Stock Dividends • GlobeNewswire Inc. • 09/25/2023 11:30:00 AM
- XOMA to Present at H.C. Wainwright 25th Annual Global Investment Conference • GlobeNewswire Inc. • 09/06/2023 11:30:00 AM
- XOMA Reports Second Quarter 2023 Financial Results and Provides Update on its Royalty Monetization Strategy • GlobeNewswire Inc. • 08/08/2023 11:30:00 AM
VAYK Exited Caribbean Investments for $320,000 Profit • VAYK • Jun 27, 2024 9:00 AM
North Bay Resources Announces Successful Flotation Cell Test at Bishop Gold Mill, Inyo County, California • NBRI • Jun 27, 2024 9:00 AM
Branded Legacy, Inc. and Hemp Emu Announce Strategic Partnership to Enhance CBD Product Manufacturing • BLEG • Jun 27, 2024 8:30 AM
POET Wins "Best Optical AI Solution" in 2024 AI Breakthrough Awards Program • POET • Jun 26, 2024 10:09 AM
HealthLynked Promotes Bill Crupi to Chief Operating Officer • HLYK • Jun 26, 2024 8:00 AM
Bantec's Howco Short Term Department of Defense Contract Wins Will Exceed $1,100,000 for the current Quarter • BANT • Jun 25, 2024 10:00 AM