Navigation Links
DiaVacs's Immunotherapy Product for Treatment of Type 1 Diabetes Receives Orphan Drug Status Designation from the FDA
Date:1/6/2014

EDGEWATER, N.J., Jan. 6, 2014 /PRNewswire/ -- DiaVacs, Inc. announced today that the Office of Orphan Products Development of the Food and Drug Administration (FDA) has granted orphan drug designation for the company's type 1 diabetes mellitus (T1DM) therapy. DV-0100 is proprietary, novel and safe. The therapy halt's the body's autoimmune reaction against the pancreatic islet cells which are responsible for producing insulin, thus allowing them to produce insulin normally and reversing the trajectory of the disease. Orphan designation qualifies DV-0100 for seven years of marketing exclusivity in the U.S. if the company is the first to obtain marketing approval for this product in T1DM and also qualifies the company for certain tax credits and waivers for prescription drug user fees.

"The granting of this orphan drug designation represents a key milestone for the company," commented Dr. Haro Hartounian, CEO of DiaVacs. "We are excited by the promise that DV-0100 showed in our Phase 1 clinical trial and look forward to assessing its therapeutic potential in the ongoing Phase 2 clinical trial for this indication."

The proprietary DiaVacs technology is derived from a deep understanding of the human immune system. The company has perfected the immunology and technology to take a patient's own dendritic cells (DC) from their blood, modify the cells through the use of small interfering oligonucleotides, and vaccinate the patient by injection of these modified cells under the skin with a small needle. The cells are absorbed, trafficked to the pancreatic lymph nodes, and thereby induce tolerance. This therapy has been shown to be safe and effective in animal models of T1DM, and evidenced no safety signals in human Phase 1 trials in patients with established type 1 diabetes for five years or longer. In some patients in our Phase 1 human trial, production of endogenous insulin was measured, even after 10 y
'/>"/>

SOURCE DiaVacs, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2

Related biology technology :

1. Immunotherapy Offers New Hope for Cancer Patients: One Man’s Alternative Cancer Treatment Journey
2. Leading Cancer Research Centers Team Up To Launch Biotech Startup Focused On Cancer Immunotherapy
3. Argos Therapeutics Presents Data Showing Memory T Cell Expansion After Administration of Fully Personalized Immunotherapy Correlates with Overall Survival Benefit in Patients with Metastatic Renal Cell Carcinoma
4. FDA Review in Journal for ImmunoTherapy of Cancer Offers New Insights into Cancer Immunotherapy Product Development & Clinical Evaluation
5. Advanced Cell Diagnostics Initiates Agreement to Study Biomarkers for Cancer Immunotherapy
6. Tuberculosis Immunotherapy Grant for Immunoxel Honibe Honey Lozenges
7. UroToday Launches New Prostate Cancer Focused Content Including Immunotherapy for Metastatic Castration-resistant Patients
8. Cancer Immunotherapy Expert Joins Pacific Meso Center Research Team
9. Argos Therapeutic Arcelis™ Immunotherapy AGS-003 in Combination With Sunitinib Shows Statistically Significant Correlation of Immune System Response to Overall Survival in Phase 2 Study in Patients with Advanced Renal Cell Carcinoma (RCC)
10. Star Scientific Receives a Warning Letter From the FDA Regarding Consumer Products
11. Marrone Bio Innovations Begins Production at Michigan Plant
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/24/2015)... , July 24, 2015 ... equities: PDL BioPharma Inc. (NASDAQ: PDLI ), Arena ... STEM ), Northwest Biotherapeutics Inc. (NASDAQ: NWBO ... Free research report on PDL BioPharma can be accessed ... the NASDAQ Composite ended at 5,146.41, down 0.49%, the ...
(Date:7/24/2015)... , July 24, 2015 Orexigen Therapeutics, Inc. ... results for the second quarter 2015 on Thursday, August ... will provide a business update and discuss the financial ... 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time). ... by calling (800) 447-0521 (domestic) or (847) 413-3238 (international), ...
(Date:7/24/2015)... July 24, 2015 The global ... reach USD 27.8 billion by 2022, growing at an ... to a new study by Grand View Research, Inc. ... expected to result in significant reduction in cost of ... adoption and usage rates of next generation sequencing throughout ...
(Date:7/24/2015)... ... July 24, 2015 , ... ... any modern scientific or pharmaceutical laboratory. FreezerPro® is an intuitive, fast, reliable ... where a sample is located even before opening the freezer door! Popular ...
Breaking Biology Technology:Biotechnology Stocks in Motion -- PDL BioPharma, Arena Pharma, StemCells, Northwest Biotherapeutics, and Acorda Therapeutics 2Biotechnology Stocks in Motion -- PDL BioPharma, Arena Pharma, StemCells, Northwest Biotherapeutics, and Acorda Therapeutics 3Biotechnology Stocks in Motion -- PDL BioPharma, Arena Pharma, StemCells, Northwest Biotherapeutics, and Acorda Therapeutics 4Biotechnology Stocks in Motion -- PDL BioPharma, Arena Pharma, StemCells, Northwest Biotherapeutics, and Acorda Therapeutics 5Next Generation Sequencing (NGS) Market To Reach $27.8 Billion By 2022: Grand View Research, Inc. 2Next Generation Sequencing (NGS) Market To Reach $27.8 Billion By 2022: Grand View Research, Inc. 3Next Generation Sequencing (NGS) Market To Reach $27.8 Billion By 2022: Grand View Research, Inc. 4Next Generation Sequencing (NGS) Market To Reach $27.8 Billion By 2022: Grand View Research, Inc. 5RURO, Inc. Partners with Integrated Systems Engineering to Provide Comprehensive LIMS Software to Biobanks 2RURO, Inc. Partners with Integrated Systems Engineering to Provide Comprehensive LIMS Software to Biobanks 3RURO, Inc. Partners with Integrated Systems Engineering to Provide Comprehensive LIMS Software to Biobanks 4
... Sunflower Oils drive better restaurant menu optionsINDIANAPOLIS, Feb. 25 ... milestone in North America with the reduction of nearly ... over the past three years. Since the market introduction ... Dow AgroSciences, have replaced more than 340 million pounds ...
... the preclinical development of CureDM,s HIP2B peptide targeted for the treatment of ... ... February 25, 2009 -- Calvert Research, LLC (a Calvert ... with CureDM to continue the preclinical development of CureDM,s HIP2B ...
... into mouse and human patients, researchers at VIB connected to ... same gene suppresses cancer in all three. Reciprocally, switching off ... a good chance that the gene can be switched on ... reputed scientific journal PLoS Biology . , , Specialized ...
Cached Biology Technology:Heart Health Month Milestone: Half a Billion Pounds of Bad Fats Eliminated From North American Diet 2Heart Health Month Milestone: Half a Billion Pounds of Bad Fats Eliminated From North American Diet 3Calvert Research and CureDM Sign Collaborative Agreement 2Calvert Research and CureDM Sign Collaborative Agreement 3Anti-cancer gene discovered: Perspective for therapy 2
(Date:7/8/2015)... , July 8, 2015  Trovagene, Inc. ... molecular diagnostics, today announced the launch of a ... Company,s Precision Cancer Monitoring℠ (PCM) technology for predicting ... one or a combination of the novel immunotherapy ... (nivolumab), a PD-1 inhibitor. The 50-patient study will ...
(Date:7/2/2015)... June 25, 2015 ... addition of the "Natural Language Processing Market ... IVR, OCR, Pattern & Image Recognition) - Worldwide ... The key vendors occupying the market ... Corporation, Microsoft Corporation, NetBase Solutions, SAS Institute Inc., ...
(Date:6/29/2015)... 24, 2015 Research and ... "Latin America Biomedical Sensors Market - Growth, Trends ... The Latin America Biomedical Sensors market is estimated ... 2.04% over the period 2014-2020 The near ... the genetic formulation of each individual. These sensors can ...
Breaking Biology News(10 mins):Trovagene Initiates Study to Monitor Response to Immunotherapy in Melanoma Patients Using its Precision Cancer Monitoring Platform 2Trovagene Initiates Study to Monitor Response to Immunotherapy in Melanoma Patients Using its Precision Cancer Monitoring Platform 3Trovagene Initiates Study to Monitor Response to Immunotherapy in Melanoma Patients Using its Precision Cancer Monitoring Platform 4Natural Language Processing Market by Type (Rule-Based, Statistical, and Hybrid), Technologies (Recognition, IVR, OCR, Pattern & Image Recognition) - Worldwide Forecast to 2020 2Latin America Biomedical Sensors Market Report 2015-2020 2
... climate shows that the Sahel region, which experienced catastrophic ... wetter monsoons for decades to come. However, drought across ... consistent with an increase in greenhouse gases appears to ... Africa's monsoons. , James Hurrell of the National Center ...
... centimetre-long nails spoke volumes. But now definitive corroborating DNA evidence ... grizzly bear. The discovery fuels mounting evidence that Canada's High ... bear -- Nanuk is having to make room for its ... bear (Ursus arctos) was discovered on Melville Island, an uninhabited ...
... whales, found during the summer in Alaska waters, is one ... Commercial whaling in the 1800s has now left us with ... as a different species from right whales seen in the ... help define areas and ecological parameters critical to the survival ...
Cached Biology News:Africa to take it on chin again with climate change 2Africa to take it on chin again with climate change 3Grizzlies set to invade high Arctic? 2Habitat use by North Pacific right whales, Eubalaena japonica, in the Bering Sea and Gulf of Alaska 2
... trays are disposable trays that ... that have been blotted onto ... eight 10.5 cm x 5 ... cut from blotted membrane and ...
... and experiment control software. Records waveform, ... and off-line analysis. powerful stimulus generation ... allowing the user to customize the ... range from basic data logging to ...
... • Small design specifically for western blots ... are specifically designed for staining western blots. ... 25 mm) of the disposable tray requires ... significant cost savings to the user. Pour ...
... pLivSelect is a ... for recombinant identification. Recombinant ... colony survival, eliminating the ... screening. This quick and ...
Biology Products: