Navigation Links
Allos Therapeutics' PDX Granted Orphan Medicinal Product,Designation by the European Commission

WESTMINSTER, Colo., April 19, 2007 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc. today announced that the Commission of the European Communities, with a favorable opinion of the Committee for Orphan Medicinal Products of the European Medicines Agency (EMEA), has granted orphan drug designation to the Company's novel antifolate PDX (pralatrexate) for the treatment of patients with peripheral T-cell lymphoma (PTCL). In July 2006, the U.S. Food and Drug Administration (FDA) awarded orphan drug designation to PDX for the treatment of patients with T-cell lymphoma. In October 2006, the FDA granted fast track designation to PDX for the treatment of patients with T-cell lymphoma.

"This designation underscores the critical need for new therapies to treat peripheral T-cell lymphoma and reinforces our belief that PDX has the potential to become an important therapeutic option for patients with this devastating disease," said Paul L. Berns, President and Chief Executive Officer.

The EMEA Orphan Medicinal Product Designation is intended to promote the development of drugs that may provide significant benefit to patients suffering from rare diseases identified as life-threatening or very serious. Under EMEA guidelines, Orphan Medicinal Product Designation provides ten years of potential market exclusivity once the product candidate is approved for marketing for the designated indication in the European Union. Orphan Medicinal Product Designation also provides potential protocol assistance, advice on the conduct of clinical trials, a reduced Marketing Authorization Application (MAA) filing fee for the drug's sponsor and the potential for grant funding.

PDX is currently the subject of PROPEL, a pivotal Phase 2, international, multi-center, open-label, single-arm study that will seek to enroll 100 evaluable patients with relapsed or refractory PTCL who have progressed after at least one prior treatmen
'"/>




Page: 1 2 3 4

Related medicine technology :

1. Allos Therapeutics Reports Results for Phase 3 Enrich Study of Efaproxyn in Women With Brain Metastases Originating From Breast Cancer
2. Halozyme Therapeutics Enhanze Technology Large Protein Molecule Therapeutic Clinical Trial Results Presented at the 34th Annual Meeting of the Controlled Release Society
3. A 4-Week Therapy with Transition Therapeutics E1-I.N.T. Leads to Sustained Reductions in Blood Glucose Levels for 6 Months Post-treatment in Type 2 Diabetes Patients
4. Pixantrone Granted Fast Track Designation by FDA for Relapsed Indolent NHL Patients
5. Sirion Therapeutics Receives Orphan Drug Designation for Ophthalmic Drug to Treat Viral Eye Infection
6. DUSA Pharmaceuticals Receives Orphan Drug Desi gnation for Levulan PDT to Treat Esophage al Dysplasia
7. AOP Orphan Pharmaceuticals and Lantibio Announce Positive Phase II Study with Novel Cystic Fibrosis Therapy
8. Generex Biotechnology to Make Presentations At 46th Annual Meeting of the European Society of Pediatric Endocrinology
9. Positive ZIO-201 Interim Phase II Sarcoma Data Presented at European Society for Medical Oncology
10. DOR BioPharma Announces Issuance of European Patent for Its Oral Multivalent Botulinum Toxin Vaccine BT-VACC
11. European Society for Medical Oncology (ESMO) Presents Data from the Clinical Trial of MediGenes Cancer-Killing Virus in Press Conference
Post Your Comments:
(Date:9/2/2014)... According to the new market research report ... Material (Metal, Glass, Plastic), by Application [GC, LC (HPLC, ... by MarketsandMarkets, the Chiral Chromatography Columns Market was valued ... at a CAGR of 5.2% from 2013 to reach ... market data tables and 15 figures spread through 135 ...
(Date:9/2/2014)... September 2, 2014 , Registry ... quality of life and treatment satisfaction [ 1 ... ]        (Photo: ... 02 September 2014, Barcelona, Spain : ... PREvention oF thromboembolic events-European Registry in Atrial Fibrillation (PREFER ...
(Date:9/2/2014)... RALEIGH, N.C. and ,S-HERTOGENBOSCH, the ... Europe ( http://www.healthlinkeurope.com ) has expanded its North American ... 100% medical facility, providing warehousing, fulfillment and order to ... North America , utilizing our global ERP platform. ... since 1994 serving our customers in Europe ...
Breaking Medicine Technology:Chiral Chromatography Column Market Worth $87.8 Million by 2018 2Chiral Chromatography Column Market Worth $87.8 Million by 2018 3Chiral Chromatography Column Market Worth $87.8 Million by 2018 4One Year Data from the PREFER in AF Registry Show Significant Changes in Atrial Fibrillation (AF) Management in Europe and Implementation of Clinical Guidelines 2One Year Data from the PREFER in AF Registry Show Significant Changes in Atrial Fibrillation (AF) Management in Europe and Implementation of Clinical Guidelines 3One Year Data from the PREFER in AF Registry Show Significant Changes in Atrial Fibrillation (AF) Management in Europe and Implementation of Clinical Guidelines 4One Year Data from the PREFER in AF Registry Show Significant Changes in Atrial Fibrillation (AF) Management in Europe and Implementation of Clinical Guidelines 5One Year Data from the PREFER in AF Registry Show Significant Changes in Atrial Fibrillation (AF) Management in Europe and Implementation of Clinical Guidelines 6One Year Data from the PREFER in AF Registry Show Significant Changes in Atrial Fibrillation (AF) Management in Europe and Implementation of Clinical Guidelines 7One Year Data from the PREFER in AF Registry Show Significant Changes in Atrial Fibrillation (AF) Management in Europe and Implementation of Clinical Guidelines 8HealthLink Europe opens North American medical warehouse operation 2
(Date:9/2/2014)... York (PRWEB) September 02, 2014 - ... defined as a class of diagnostic test that analyzes ... The nucleic acids and proteins that belong to individual ... therapy, health condition, or risk of developing a specific ... better known as (MDx) evaluating the new class of ...
(Date:9/2/2014)... 02, 2014 Welcome to Arthritis ... 4.6 million Canadians living with the disease, The Arthritis ... Arthritis” video series featuring well-known Canadians from different walks ... ,      Lloyd Robertson , veteran news anchor ... skier ,      Amy Cotton , two-time ...
(Date:9/2/2014)... there might be a new salve to dominate medicine cabinets ... lowly salamander. Salamanders may not be the cuddliest of animals, ... of seriously damaged body parts. Now, a new report published ... Journal , identifies a small protein (called a "peptide") ... to unlocking the secret of this amazing wound healing trick ...
(Date:9/2/2014)... Two Kansas State University biochemists have discovered a family ... Staphylococcus aureus , a pathogenic bacterium that can ... , Brian Geisbrecht, professor of biochemistry and molecular biophysics, ... S. aureus , which is the cause of increasing ... journal Proceedings of the National Academy of Sciences ...
(Date:9/2/2014)... New York (PRWEB) September 02, 2014 ... the bony block or the vertebrae in our spine ... are the most common fractures in people with osteoporosis ... major reason behind such fractures, forms of metastatic tumors ... fall or a sports injury can also lead to ...
Breaking Medicine News(10 mins):Health News:Molecular Diagnostic Market: Global Factors and Perspectives by Transparency Market Research 2Health News:Molecular Diagnostic Market: Global Factors and Perspectives by Transparency Market Research 3Health News:Molecular Diagnostic Market: Global Factors and Perspectives by Transparency Market Research 4Health News:‘Voices of Arthritis’ Launches Awareness Month 2Health News:‘Voices of Arthritis’ Launches Awareness Month 3Health News:Salamander skin peptide promotes quick and effective wound healing in mice 2Health News:Biochemists find new treatment options for staph infections, inflammatory diseases 2Health News:An Overview of the Minimally Invasive Vertebral Compression Fracture Repair Market by Transparency Market Research 2Health News:An Overview of the Minimally Invasive Vertebral Compression Fracture Repair Market by Transparency Market Research 3
... to the diet may help reduce the risk of developing ... more than 95,000 women who never had kidney stones, researchers ... the study. Women who consumed the most calcium had a ... who consumed the least amount. The use of calcium supplements ...
... calcium to the diet may help reduce the risk of ... of more than 95,000 women who never had kidney stones, ... of the study. Women who consumed the most calcium had ... women who consumed the least amount. The use of calcium ...
... that by adding more calcium to the diet may help ... ,In a study of more than 95,000 women who ... over the eight years of the study. Women who consumed ... kidney stones compared to women who consumed the least amount. ...
... in the United States suffer a stroke. About one-third of ... to perform daily functions that consume lots of energy, such ... research shows , stroke survivors should be urged to exercise ... seven times a week, can help reduce the risk of ...
... strategies to improve lifestyle habits may not lower blood ... reading .// ,Researchers investigated whether simple interventions, ... lower sodium intake, and advice for a healthier diet, ... care. Nearly 300 patients without an established history of ...
... dental X-rays during pregnancy are three-times more likely to ... study.// ,Researchers studied about 4,500 women. They found ... have babies weighing less than five pounds. Specialists seem ... pregnant women were exposed to was very low and ...
Cached Medicine News:
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: