Navigation Links
Jennerex, Inc. Receives EMEA Orphan Drug Designation for JX-594 for the Treatment of Hepatocellular Carcinoma
Date:10/19/2009

SAN FRANCISCO, Oct. 19 /PRNewswire/ -- Jennerex, Inc. (San Francisco, CA and Ottawa, Ontario), a clinical stage biotherapeutics company developing a proprietary breakthrough product class of targeted oncolytic virus therapeutics, today announced that the European Medicines Agency (EMEA) has granted Orphan Drug Designation to Jennerex's product JX-594 for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. JX-594 is expected to enter a Phase 3 pivotal trial in the second half of 2010.

European Orphan Drug Designation encourages the development of products that demonstrate promise for the treatment of a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union. The designation criteria also specify that there is no other satisfactory therapy for that indication and that if JX-594 is shown to be effective in pivotal trials, it would represent a significant clinical benefit to HCC patients. Orphan Drug status for JX-594 entitles Jennerex to 10 year market exclusivity in Europe if the Market Authorization Application (MAA) is approved as well as potentially increasing reimbursement pricing. The designation also confers special benefits, including eligibility for protocol assistance and possible exemptions or reductions in certain regulatory fees during development or at the time of application for marketing approval.

"This designation is an important step in the development of a potential breakthrough treatment for this lethal disease," said David H. Kirn, M.D., President and Chief Executive Officer of Jennerex. "We look forward to working closely with the European regulatory authorities to complete the global development of JX-594 for the treatment of primary liver cancer."

About Hepatocellular Carcinoma

The treatment of advanced hepatocellular carcinoma represents a significant unmet medical need. HCC
'/>"/>

SOURCE Jennerex, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
2. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
3. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
4. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
5. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
6. CryoCor Receives FDA Approval for Right Atrial Flutter
7. Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
8. Dimericine(R) Receives FDA Fast Track Designation for Treatment Of Photosensitivity in XP Patients
9. Poniard Pharmaceuticals Receives FDA Fast Track Designation for Picoplatin for Treatment of Small Cell Lung Cancer
10. Kosan Receives Completed Special Protocol Assessment for TIME-1 Pivotal Phase 3 Trial of Tanespimycin in Multiple Myeloma
11. The Female Health Company Receives USAID DELIVER PROJECT Order for 5 Million Units
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/30/2014)... FOSTER CITY, Calif. , Sept. 30, 2014 ... lifecycle management (PLM) applications, today announced its Fall ... Arena Scribe and Arena DataExtract ... Quality . The newly available products are focused ... real-time communication and the aggregation of a complete ...
(Date:9/30/2014)... , Sept. 30, 2014 One week after ... major milestone: Alzheimer,s Team reaches over 200,000 ... and caregivers, was developed to draw attention to clinical ... disease. It also provides inspirational support and fosters online ... as the leading healthcare concern for people over the ...
(Date:9/30/2014)... ANAHEIM, Calif. , Sept. 30, 2014 ... Products. (OTC: GWPC) is a diversified company comprised of ... convenience of advanced technology and the proven expertise of ... of health and wellness. WholeHealth Products, line of more ... and healthcare centers, and its more than 8 retail ...
Breaking Medicine Technology:Arena Unveils Unique PLM Collaboration Platform And New Data Extraction Tool 2Arena Unveils Unique PLM Collaboration Platform And New Data Extraction Tool 3Arena Unveils Unique PLM Collaboration Platform And New Data Extraction Tool 4MediciGlobal's Alzheimer's Community Reaches 200,000 likes and more than half a million weekly visitors 2MediciGlobal's Alzheimer's Community Reaches 200,000 likes and more than half a million weekly visitors 3MediciGlobal's Alzheimer's Community Reaches 200,000 likes and more than half a million weekly visitors 4WholeHealth Products Announces The Discovery Of The "Autism And Fragile X" Microwell And Rapid Diagnostic Test 2
... NEW BRUNSWICK, N.J., March 16, 2011 Working with the ... Research Ltd, headquartered in Moscow, Russia, has donated $100,000 to ... in the Department of Pharmacology at UMDNJ-Robert Wood Johnson Medical ... New Jersey.   The Blue Sky Research and ...
... Dynatronics Corporation (Nasdaq: DYNT ) announced ... RB Milestone Portfolio, a group of companies selected by ... the market via a combination of traditional and innovative ... Network™, and non-deal roadshows, with a focus on the ...
Cached Medicine Technology:International Biotech Firm Funds Research Into Aging Through Foundation of UMDNJ 2Dynatronics Selected for Inclusion in RB Milestone Portfolio 2
(Date:9/30/2014)... September 30, 2014 FDA-approved injectable ... Poly-L-lactic acid) are used in several procedures that ... in patients, but are primarily used for wrinkle ... rejuvenation—in particular, these fillers are being used as ... restoring smoother skin in the hands. (1) (2) ...
(Date:9/30/2014)... Healthpointe is proud to announce that ... and ankle reconstruction surgeries to assist patients with severe ... specializes in the diagnosis and treatment of sports medicine, ... also trained to perform advanced Foot and Ankle Reconstruction ... is also fluent in Spanish. , Reconstructive surgical procedures ...
(Date:9/30/2014)... TX (PRWEB) September 30, 2014 To ... the Editorial Board of Living with a Disability ... sheds light on hematological disorders as disabling conditions. ... requires more than a diagnosis to establish a disability ... chronic thrombocytomenia, myelofibrosis, hereditary telangiectasia, coagulation defects, polycythemia vera, ...
(Date:9/30/2014)... Jiwa Law Corporation, a personal injury law firm in ... offering free consultation for personal injury claims of their clients. ... the first time to meet the Vancouver ICBC lawyers will ... understand what their rights are. The experts at Jiwa Law ... to them what the law firm can do regarding their ...
(Date:9/30/2014)... (PRWEB) September 30, 2014 Coast ... grand opening of its newest practice, located at 1010 ... digital x-rays, general dentistry services , and specialty ... In addition to providing affordable and convenient dental care, ... emergency dental appointments . Call Coast Dental at 559-777-6113 ...
Breaking Medicine News(10 mins):Health News:Nonsurgical Cosmetic How-To: Skinspirations Details Proper Use of FDA-Approved Injectable Fillers for Hand Rejuvenation Procedures 2Health News:Nonsurgical Cosmetic How-To: Skinspirations Details Proper Use of FDA-Approved Injectable Fillers for Hand Rejuvenation Procedures 3Health News:Nonsurgical Cosmetic How-To: Skinspirations Details Proper Use of FDA-Approved Injectable Fillers for Hand Rejuvenation Procedures 4Health News:Fellowship-Trained and Board-Certified Orthopedic Specialist Now Performing Advanced Foot & Ankle Reconstruction Surgeries 2Health News:Fellowship-Trained and Board-Certified Orthopedic Specialist Now Performing Advanced Foot & Ankle Reconstruction Surgeries 3Health News:Living with a Disability Magazine Marks National Sickle Cell Health Month with New Article on Hematological Disorders 2Health News:Living with a Disability Magazine Marks National Sickle Cell Health Month with New Article on Hematological Disorders 3Health News:Jiwa Law Corporation Now Offers Personal Injury Consultation Without Any Charge 2Health News:Coast Dental Clovis Celebrates Grand Opening 2Health News:Coast Dental Clovis Celebrates Grand Opening 3
... Oct. 28 /Xinhua-PRNewswire-FirstCall/ -- China Sky One,Medical, ... Company") (Nasdaq: CSKI ), a,leading fully ... People,s Republic of China ("PRC"), announced today ... a proprietary breast drug from,Harbin Medical University ...
... Contribute to Blood Vessels, Healthy ... Ability to Relax, ... component of soy may enhance the function of arteries,in stroke patients, and ... and Prevention, heart disease is the,nation,s number one killer while stroke is ...
... Oct. 28 The Los Angeles Shambhala Center,presents a public ... the weekend, Oct 30 and November 1st and 2nd., ... Japan will,appear for the first time in Los Angeles at ... at Figueroa and Colorado Blvd.,in Eagle Rock., On Thursday, ...
... WellSpring Pharmaceutical,Corporation, a growing North American-based pharmaceutical manufacturer,today ... Operating Officer.,Formerly, Ms. Shusko held the position of ... 2000. In her new role as COO, Ms. ... of oversight,to operations with an initial focus on ...
... /PRNewswire-FirstCall/ - Response Biomedical,Corporation (TSX: RBM, OTCBB: RPBIF) ... initial closing of the financing announced on October,14, ... gross proceeds of $4.66,million. The closing involved a ... a price of $0.15 for each unit. Each ...
... for internet-based public reporting to help consumers ... WASHINGTON Oct. 28 To support consumer,engagement ... Quality Forum,(NQF) endorsed guidelines for consumer-focused, internet-based ... to present,information about hospital quality in an ...
Cached Medicine News:Health News:China Sky One Medical, Inc. Acquires Drug to Treat Breast Lesions 2Health News:China Sky One Medical, Inc. Acquires Drug to Treat Breast Lesions 3Health News:Study Shows How Soy Compound Lowers Blood Pressure and Stroke Risk 2Health News:Renowned Kyudo (Zen archery) Master Kanjuro Shibata Sensei to Present in L.A. 2Health News:WellSpring Pharmaceutical Corp. Names Wendy Shusko as New Chief Operating Officer 2Health News:Response Biomedical Completes Initial Closing of an expected $5.0 Million Financing 2Health News:Response Biomedical Completes Initial Closing of an expected $5.0 Million Financing 3Health News:Response Biomedical Completes Initial Closing of an expected $5.0 Million Financing 4Health News:NQF Endorses Guidelines for Consumer-Focused Public Reporting 2Health News:NQF Endorses Guidelines for Consumer-Focused Public Reporting 3Health News:NQF Endorses Guidelines for Consumer-Focused Public Reporting 4Health News:NQF Endorses Guidelines for Consumer-Focused Public Reporting 5
Stryker autoclavable pediatric laparoscopes provide equivalent brightness and resolution along with the unparalleled durability found in larger laparoscopes....
The flexible nature of the vinyl allows the user to reach deeper into the chamber and allows for a greater comfort when working inside the glove box over a long period of time compared to any rigid s...
Bactron IV is designed for high volume, yet requires far less bench space than expected for its capacity and performance features....
Designed for larger laboratories or research applications, the Concept 1000 boasts some very unique features....
Medicine Products: