Targazyme Inc. Receives Orphan Drug Designation to TZ101 for Use With Regulatory T Cells to Prevent & Reduce the …
Posted: March 10, 2015 at 1:43 pm
Orphan Designation Provides 7-Year Post Approval Marketing Exclusivity, Tax Credits and Elimination of FDA Prescription Drug User Fees
SAN DIEGO, CA--(Marketwired - February 10, 2015) - Targazyme Inc., a clinical-stage biopharmaceutical company developing enzyme technologies and products to improve efficacy outcomes for stem cell transplantation, immunotherapy, gene therapy and regenerative medicine, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to TZ101 to prevent and reduce the severity and incidence of graft vs. host disease (GVHD) in patients eligible for hematologic stem cell transplant.
GVHD is a serious, life-threating complication of stem cell transplantation.Orphan drug status confirms the importance of Targazyme's novel treatment approach to prevent and reduce the incidence and severity of GVHD in patients with blood cancers where stem cell transplant is prescribed.TZ101 could potentially transform hematopoietic stem cell transplantation by reducing patient morbidity and mortality from GVHD, which occurs in a large percentage of these patients and is very difficult to manage clinically.
"Our work with TZ101 demonstrates impressive increases in the persistence and activity of regulatory T cells in preclinical models of GVHD," said Dr. Elizabeth J. Shpall, Deputy Chair of the Department of Stem Cell Transplantation and Cellular Therapy at The University of Texas MD Anderson Cancer Center."We are looking forward to beginning clinical trials on this promising modality for preventing GVHD in our patients undergoing stem cell transplantation."
Orphan Drug Designation by FDA confers financial benefits and incentives, such as potential Orphan Drug grant funding to defray the cost of clinical testing, tax credits for the cost of clinical research, a 7 year period of exclusive marketing after Approval and a Waiver of Prescription Drug User Fee Act (PDUFA) filing fees which are now greater than $2 million.
"The granting of Orphan Drug status for TZ101 for prevention of GVHD in stem cell transplant patients, as well as our previous Orphan Drug designation of TZ101 for cord blood transplantation, provides additional validation of our innovative platform technologies," said Lynnet Koh, Chairman & Chief Executive Officer of Targazyme."TZ101 and our second product, TZ102 are enabling technologies for improving efficacy outcomes for multiple cell-based therapeutic approaches used to prevent and treat a variety of different diseases for which there is a high unmet medical need.In addition to initiating our registration trial with TZ101 in hematopoietic stem cell transplantation, we plan to embark on our cancer immunotherapy trial later this year."
About Targazyme, Inc.
Targazyme Inc. is a San Diego-based, clinical-stage biopharmaceutical company developing novel enzyme-based platform technologies and products to improve clinical efficacy outcomes for stem cell medicine, auto-immunotherapy, gene therapy and regenerative medicine.
The company's clinical-grade fucosyltransferase enzymes and small molecule products (TZ101 and TZ102) are off-the-shelf products used at the point-of-care to treat therapeutic cells immediately before infusion into the patient using a simple procedure that is easily incorporated into existing medical practice.The company has received a number of world-wide patents, multiple FDA orphan drug designations and major medical/scientific awards and grants.
Targazyme has partnerships and collaborations with Kyowa Hakko Kirin and Florida Biologix, as well as various medical research institutions including The University of Texas MD Anderson Cancer Center, Oklahoma Medical Research Foundation, Texas Transplant Institute, Case Western/University Hospitals, Scripps Hospitals, Fred Hutchinson Cancer Research Center, UCLA Medical Center, Stanford University Medical Center, University of Minnesota Medical Center, University of California San Diego, Sanford-Burnham Medical Research Institute, Indiana University, Memorial Sloan Kettering Cancer Center, and New York Blood Center.For more information please go to http://www.targazyme.com.
View original post here:
Targazyme Inc. Receives Orphan Drug Designation to TZ101 for Use With Regulatory T Cells to Prevent & Reduce the ...
- Eli and Edythe Broad Center of Regeneration Medicine and ... - October 30th, 2015
- Molecular & Cellular Medicine - October 29th, 2015
- Sickle cell anemia Treatments and drugs - Mayo Clinic - October 29th, 2015
- How are stem cells used in medicine today? - HowStuffWorks - October 29th, 2015
- Oxidative Medicine and Cellular Longevity An Open Access ... - October 29th, 2015
- Department of Regenerative Medicine and Cell Biology - October 29th, 2015
- Sickle Cell Anemia: MedlinePlus - National Library of Medicine - October 29th, 2015
- Personalized RegenerativeMedicine : Dr David Steenblock - October 29th, 2015
- Cell Therapy and Regenerative Medicine - October 29th, 2015
- The Power of Stem Cells | California's Stem Cell Agency - October 29th, 2015
- Herbal medicine | Cancer Research UK - October 29th, 2015
- UR Stem Cell and Regenerative Medicine Institute (SCRMI) - October 29th, 2015
- Penn Medicine News: Genetically Modified "Serial Killer" T ... - October 29th, 2015
- Beta cell regeneration - Center for Regenerative Medicine ... - October 29th, 2015
- The Stem Cell Theory of Cancer - Stanford Medicine Center - October 29th, 2015
- What is a cell? - Genetics Home Reference - October 16th, 2015
- Cell Therapy & Regenerative Medicine - University of Utah ... - October 13th, 2015
- Sickle Cell Anemia: Learn About SCD Symptoms and Treatment - September 26th, 2015
- Research - Stem Cell Biology and Regenerative Medicine ... - September 26th, 2015
- Sickle Cell Disease (Sickle Cell Anemia ... - MedicineNet - September 26th, 2015
- T Cell Therapy (CTL019) | The Children's Hospital of ... - September 15th, 2015
- Knoepfler Lab Stem Cell Blog | Building innovative ... - September 10th, 2015
- Cell culture - Wikipedia, the free encyclopedia - September 6th, 2015
- What are the potential uses of human stem cells and the ... - August 17th, 2015
- One type of airway cell can regenerate another lung cell type - April 13th, 2015
- Limber Lungs: One Type of Airway Cell Can Regenerate Another Lung Cell Type - April 13th, 2015
- Regenestem Network Announces Plans to Attend the 23rd Annual World Congress on Anti-Aging Medicine May 7-9, 2015 - April 6th, 2015
- 'Open' stem cell chromosomes reveal new possibilities for diabetes - April 3rd, 2015
- Key mechanism identified in tumor-cell proliferation in pediatric bone cancers - April 3rd, 2015
- UCI team gets $5 million to create stem cell treatment for Huntington's disease - March 28th, 2015
- Sungduan: Growth factors - March 28th, 2015
- Cleveland Clinic Researchers First to Demonstrate Significant Blocking of Opioid Tolerance With Mesenchymal Stem Cell ... - March 25th, 2015
- Johns Hopkins Medicine, based in Baltimore, Maryland - March 23rd, 2015
- stem cell medicine Jakarta tangerang serpong bsd bintaro - Video - March 21st, 2015
- Global Stem Cells Group to Hold Practical Adipose-Derived Stem Cell Harvesting, Isolation and Re-integration Training ... - March 20th, 2015
- Boston Stem Cell Biotech Start-up Asymmetrex Will Present Essential Technologies for Stem Cell Medical Engineering at ... - March 18th, 2015
- A Single-Cell Breakthrough: newly developed technology dissects properties of single stem cells - March 18th, 2015
- BrainStorm Cell Therapeutics to Present at 3rd Annual Regen Med Investor Day on March 25 in New York - March 18th, 2015
- Global Stem Cells Group to Participate in the 25th Argentine Congress of Aesthetic Medicine in Buenos Aires April 9-10 ... - March 17th, 2015
- Boosting A Natural Protection Against Alzheimer's Disease - March 13th, 2015
- Media portray unrealistic timelines for stem cell therapies - March 12th, 2015
- Stem cells lurking in tumors can resist treatment - March 12th, 2015
- Building custom blood cells to battle sickle cell disease - March 11th, 2015
- Johns Hopkins researchers engineer custom blood cells - March 10th, 2015
- Mast cell - Wikipedia, the free encyclopedia - March 9th, 2015
- Achieving gender equality in science, engineering and medicine - March 9th, 2015
- Seven strategies to advance women in science - March 9th, 2015
- British biotech firm sets crowdfunding record with heart drug - March 9th, 2015
- A good night's sleep keeps your stem cells young - March 9th, 2015
- Howe's recovery shows stem-cell advances - March 1st, 2015
- Translational Regenerative Medicine: Market Prospects 2015-2025 - February 28th, 2015
- Stem cellrecruiting hydrogels based on self-assembling peptides for tissue regeneration - February 25th, 2015
- Sertoli cell - Wikipedia, the free encyclopedia - February 17th, 2015
- Global Stem Cells Group Announces Alliance with Regenerative Technology - February 11th, 2015
- Biotech firm Cell Therapy claims crowdfunding record with heart drug - February 10th, 2015
- Two UC San Diego Scientists Receive Stem Cell Technology Grants - February 3rd, 2015
- Regenestem Network and Gilberto Hernandez Falcon, M.D. Open Stem Cell Clinic in Yucatan - January 31st, 2015
- Global Stem Cells Group and Regenestem Network Announce Launch of New Stem Cell and Regenerative Medicine Clinic in ... - January 29th, 2015
- Asymmetrex Scheduled to Present Unique Perspectives in Stem Cell Biology and Recent Advances in Technologies for Adult ... - January 29th, 2015
- Gordie Howe's stem cell therapy raises concerns among medical experts - January 29th, 2015
- Gordie Howe's stem cell therapy raises concerns among experts - January 29th, 2015
- BioTime Announces Issuance of 14 New Patents in the Fields of Regenerative Medicine, Stem Cell Technology, and Cancer ... - January 27th, 2015
- Keeping the Kraken asleep - January 27th, 2015
- Helmholtz International Fellow Award for Prof. Amanda Fisher from London - January 27th, 2015
- Regenestem Network, a division of Global Stem Cells Group, Announces Launch of New Stem Cells and Regenerative ... - January 22nd, 2015
- Scientists announce revolutionary culturing technique for liver and pancreas - January 22nd, 2015
- New Type of Cell Found to Repair Lung Injury in Mice - January 18th, 2015
- Stem cells derived from amniotic tissues have immunosuppressive properties - January 16th, 2015
- Global Stem Cells Group to Move Headquarters to Larger Miami Lakes Office Complex - January 14th, 2015
- Peter S. Kim Named the Virginia and D.K. Ludwig Professor of Biochemistry at Stanford - January 13th, 2015
- Renowned professor's book addresses stem cell biology & regenerative medicine - January 13th, 2015
- Circadian rhythms regulate skin stem cell metabolism and expansion, study finds - January 7th, 2015
- Cord Blood Banking Leader, Cryo-Cell International, Continues to Support the Advancement of Regenerative Medicine - January 6th, 2015
- Scientists Develop Pioneering Method to Define Stages of Stem Cell Reprogramming - January 6th, 2015
- Pioneering method developed to define stages of stem cell reprogramming - January 6th, 2015
- The Irvine Stem Cell Treatment Center Announces Adult Stem Cell Public Seminars in Orange County, California - January 5th, 2015
- Ten years in, California's stem cell program is getting a reboot - January 4th, 2015
- Two-thirds of cancer cases are "bad luck," study says - January 1st, 2015
- 'Bad Luck' of Random Mutations Plays Predominant Role in Cancer, Study Shows - January 1st, 2015
- Adipose-derived Stem Cells: Current Findings and Future ... - December 30th, 2014