A PHASE III, MULTINATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE THE CLINICAL EFFICACY AND SAFETY OF DIAPEP277® IN NEWLY DIAGNOSED TYPE 1 DIABETES SUBJECTS - DIA-AID 2

Start Date17 Sep 2010

Sponsor / Collaborator

Andromeda Biotech Ltd.

NCT01103284

/ CompletedPhase 3

A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Clinical Efficacy and Safety of DiaPep277 in Newly Diagnosed Type 1 Diabetes Subjects

This study will look at the treatment effect of DiaPep277 on preservation of beta-cell function, as defined by meal-stimulated secretion of insulin. DiaPep277 is a peptide that changes the way the immune system behaves, stopping its attack on the beta-cells.
Adults (>20 years) with newly diagnosed (<6 months) type 1 diabetes will be treated with 10 injections of DiaPep277 or Placebo over a 2-year treatment and follow-up period.

Start Date01 Apr 2010

Sponsor / Collaborator

Andromeda Biotech Ltd.

NCT00644501

/ CompletedPhase 3

Open Label Study to Evaluate Long Term Treatment Effect of DiaPep277® in Patients Who Have Completed Studies 461* (Phase II) or 901** (Pase III)

The study is an open-label extension study, offering patients who participated and completed previous study 901 to continue treatment with DiaPep277 and clinical follow-up, for 2 additional years. The expectation is first to demonstrate that extended treatment with DiaPep277 is safe and second to evaluate the long-term effectiveness of treatment. Only patients who completed the previous 2-year study and still have beta-cell function above a threshold level will be eligible for this extension study.

Start Date01 Sep 2008

Sponsor / Collaborator

Andromeda Biotech Ltd.

100 Clinical Results associated with Andromeda Biotech Ltd.

0 Patents (Medical) associated with Andromeda Biotech Ltd.

Literatures (Medical) associated with Andromeda Biotech Ltd.

01 May 2014·Diabetes careQ1 · MEDICINE

Treatment of Recent-Onset Type 1 Diabetic Patients With DiaPep277: Results of a Double-Blind, Placebo-Controlled, Randomized Phase 3 Trial

Q1 · MEDICINE

Article

Author: Schernthaner, Guntram ; Distiller, Larry A. ; Dagan, Shlomo ; Wainstein, Julio ; Peled, Dana ; Procházka, Vlastimil ; Giorgino, Francesco ; Cohen, Irun R. ; Avron, Ann ; Elias, Dana ; Tamir, Merana ; Linn, Thomas ; Raz, Itamar ; Mauricio, Didac ; Eren, Rachel ; de Vries, Liat ; Ziegler, Anette G. ; Bonnici, Francois ; Giordano, Carla ; Pozzilli, Paolo

OBJECTIVE:

To evaluate safety and efficacy of DiaPep277 in preserving β-cell function in type 1 diabetic patients.

RESEARCH DESIGN AND METHODS:

DIA-AID 1 is a multinational, phase 3, balanced-randomized, double-blind, placebo-controlled, parallel-group clinical study. Newly diagnosed patients (N = 457, aged 16–45 years) were randomized to subcutaneous injections of DiaPep277 or placebo quarterly for 2 years. The primary efficacy end point was the change from baseline in the area under the glucagon-stimulated C-peptide curve. Secondary end points were the change from baseline in mixed-meal stimulated C-peptide secretion and in fasting C-peptide and achieving target HbA1c ≤7% (≤53 mmol/mol). Partial remission (target HbA1c on insulin ≤0.5 units/kg/day) and hypoglycemic event rate were exploratory end points.

RESULTS:

DiaPep277 was safe and well tolerated. Significant preservation of C-peptide secretion was observed in the DiaPep277-treated group compared with the placebo (relative treatment effects of 23.4%, P = 0.037, and 29.2%, P = 0.011, in the modified intent-to-treat [mITT] and per-protocol [PP] populations, respectively). The mixed-meal stimulation failed to distinguish between the groups. There was a trend toward efficacy in fasting C-peptide levels, though not statistically significant. Significantly more DiaPep277-treated than placebo-treated patients maintained target HbA1c (mITT 56% versus 44%, P = 0.03; PP 60% versus 45%, P = 0.0082) and entered partial remission (mITT 38% versus 29%, P = 0.08; PP 42% versus 30%, P = 0.035). DiaPep277 treatment reduced the relative hypoglycemic event risk (mITT by 20%; PP by 28%).

CONCLUSIONS:

DiaPep277 safely contributes to preservation of β-cell function and to improved glycemic control in patients with type 1 diabetes.

01 May 2014·Diabetes careQ1 · MEDICINE

Evaluation of Long-Term Treatment Effect in a Type 1 Diabetes Intervention Trial: Differences After Stimulation With Glucagon or a Mixed Meal

Q1 · MEDICINE

Article

Author: Raz, Itamar ; Peled, Dana ; Cohen, Irun R. ; Eren, Rachel ; Elias, Dana ; Avron, Ann ; Pozzilli, Paolo ; Tamir, Merana ; Dagan, Shlomo

OBJECTIVE:

Endogenous insulin secretion, measured by C-peptide area under the curve (AUC), can be tested using both the glucagon stimulation test (GST) and the mixed-meal tolerance test (MMTT). This study compares these two stimulation methods using long-term data from patients newly diagnosed with type 1 diabetes or with latent autoimmune diabetes.

RESEARCH DESIGN AND METHODS:

A recently completed phase 3 intervention study with DiaPep277 demonstrated improved glycemic control and a significant treatment effect of glucagon-stimulated C-peptide secretion. Unexpectedly, MMTT failed to detect differences between the treated and control groups. Data from 343 patients in two balanced-randomized, double-blind, placebo-controlled, parallel-group trials of DiaPep277 were used to compare and correlate between GST- and MMTT-derived C-peptide AUC. Pearson’s correlations were calculated for absolute C-peptide AUC at baseline and 12 and 24 months and for long-term changes in AUC (∆AUC).

RESULTS:

The absolute AUC values obtained at any single time point by the two tests were well correlated in both data sets (r = 0.74–0.9). However, the correlations between the ∆AUC were much weaker (r = 0.39–0.58). GST-stimulated C-peptide secretion was stable over the fasting glucose range permitted for the test (4–11.1 mmol/L), but MMTT-stimulated C-peptide secretion decreased over the same range, implying differences in sensitivity to glucose.

CONCLUSIONS:

Measurement of long-term changes in stimulated C-peptide, reflecting endogenous insulin secretion, during the course of intervention trials may be affected by the method of stimulation, possibly reflecting different sensitivities to the physiological status of the tested subject.

News (Medical) associated with Andromeda Biotech Ltd.

07 Oct 2015

·www.biospace.com

Clal Biotech Opts Out of Re-Acquiring Andromeda from Hyperion After Phase III Diabetes Drug Tanks

October 7, 2015 By Alex Keown , BioSpace.com Breaking News Staff YAVNE, Israel – Applied Genetic Technologies Corporation will not exercise its option to purchase its former subsidiary Andromeda Biotech from Hyperion Therapeutics and its parent company Horizon Pharma following the late-stage failure of the company’s experimental treatment for juvenile diabetes, Globes, an Israel-based business publication reported . Clal Biotech had an option to purchase Andromeda for a price tag of $2.5 million to $36.5 million, depending on clinical trial outcomes. However, Andromeda ’s Phase III trial for DiaPep277, a drug for the treatment of type 1 diabetes in juveniles, failed to achieve efficacy, Globes said. There is no indication yet if research will continue on the drug to see if it is a more effective diabetes treatment for other age groups. Clal Biotechnology is a life-sciences holding company. Its main holdings include Gamida Cell Ltd. , MediWound Ltd. and CureTech Ltd. , Globes reported. Clal ’s , traded on the Tel Aviv Stock Exchange, was down this morning. The stock was trading at 280.10 ILS (Israeli Shekels) down from a day’s high of 288.70 ILS. Clal ’s option to purchase Andromeda was part of an agreement with Hyperion the two companies entered into after a dispute over DiaPep277 stemming back to 2014. In April 2014, Hyperion acquired Andromeda from Clal for up to $570 million, but then scuttled trials for DiaPep277, arguing the drug’s data was not complete as it omitted results from 34 patients in violation of trial protocols. Clal sued Hyperion for $200 million, arguing that the company’s claims against them caused damage to the company’s reputation. The two companies negotiated a truce to complete trials for DiaPep277, giving Clal the option to repurchase Andromeda and the drug. In 2007, DeveloGen AG sold all rights to DiaPep277 to Andromeda, which at the time was a subsidiary of Clal Biotechnology . After Andromeda acquired the drug from DeveloGen , it c-o-developed the medication with Israel-based Teva Pharmaceutical Industries Ltd. until that company relinquished its rights to the drug in 2014, Globes reported. Teva financed most of the clinical trials surrounding DiaPep277, Globes said . After the latest DiaPep277 drama, the drug is scheduled to revert to Yeda Research and Development Company , the place where it was originally discovered. In May, Hyperion was acquired by Ireland-based Horizon Pharma for $1.1 billion. Hyperion ’s pipeline included Ravicti and Buphenyl, both used for the treatment of urea cycle disorders. Buphenyl, also known as sodium phenylbutyrate, helps by removing nitrogen from the body. Ravicti, or glycerol phenylbutyrate, eliminates ammonia in patients over 24 hours. Urea cycle disorders and metabolic disorders impact more than 2,100 people in the U.S. Earlier this year, Novo Nordisk pulled the plug on an expansion of Victoza (liraglutide) for use in type 1 diabetes after disappointing Phase III trial results. Victoza is a GLP-1 analogue used to treat type 2 diabetes. In the latest study, dubbed Adjunct One, Victoza (liraglutide) combined with an insulin improved blood glucose control in attempts to treat type 1 diabetes actually worsened episodes of low blood sugar, the company reported.

AcquisitionPhase 3Phase 2Drug Approval

24 Feb 2014

·www.biospace.com

Andromeda Biotech Acquires DiaPep277 Rights From Teva Pharmaceutical Industries Limited

YAVNE, Israel, Feb. 24, 2014 (GLOBE NEWSWIRE) -- Andromeda Biotech Ltd. announces that it entered into an agreement with Teva Pharmaceutical Industries Ltd. for the acquisition of Teva's rights for Andromeda's drug, DiaPep277®, for the treatment of Type 1 Diabetes. Help employers find you! Check out all the jobs and post your resume.

CollaborateAcquisition

12 Sep 2012

·www.biospace.com

Andromeda Biotech Successfully Completes Patient Recruitment in Phase III Confirmatory Trial for Its Lead Drug, "DiaPep277" for Type 1 Diabetes

YAVNE, Israel, Sept. 12, 2012 (GLOBE NEWSWIRE) -- Andromeda Biotech Ltd. ( ) announced today that it has completed patient recruitment in its' DIA-AID 2, a confirmatory Phase III clinical trial using DiaPep277® for the treatment of Type 1 diabetes.

100 Deals associated with Andromeda Biotech Ltd.

100 Translational Medicine associated with Andromeda Biotech Ltd.

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