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:1/15/2014)... 2014 The Cadence Fitness & Health Center has ... Medical Fitness Association, a non-profit organization assisting medically integrated ... The Cadence Fitness & Health Center is the only ... in the Chicagoland area. "The certification means ...
(Date:1/15/2014)... NEW YORK , Jan. 15, 2014 ... research report is available in its catalogue: ... - India Drug Forecast and Market Analysis ... PharmaPoint: Atopic Dermatitis - India ...
(Date:1/15/2014)... YORK , Jan. 15, 2014 ... market research report is available in ... Global Markets and Technologies for Advanced ... Routes of Administration ...
Breaking Medicine Technology:Cadence Fitness & Health Center Certified as Medical Fitness Facility 2Cadence Fitness & Health Center Certified as Medical Fitness Facility 3PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 2PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 3PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 4PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 5Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 2Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 3Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 4Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 5Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 6Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 7Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 8Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 9Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 10Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 11Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 12Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 13Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 14Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 15Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 16
... ConvaTec, a world-leading developer and marketer of ... today announced that Holy Family Medical Center will ... line of products designed to overcome the clinical ... Negative Pressure features the Engenex ® System ...
... 2011 iCyt Mission Technology, Inc. (iCyt), a wholly-owned ... introduction of its new line of 405nm-excited fluorochrome conjugated ... products are part of the first commercial release of ... exciting new class of fluorescent probes will make significant ...
Cached Medicine Technology:Holy Family Medical Center Selects ConvaTec Negative Pressure for Wound Care 2Holy Family Medical Center Selects ConvaTec Negative Pressure for Wound Care 3iCyt Unveils Exciting New Flow Cytometry Reagents Utilizing Innovative Fluorochrome Technology 2
(Date:4/23/2014)... Spokane have developed a new way to detect ... the wheel. , Their recently patented technology is ... in drowsy driversand offers an affordable and more ... detection systems. , Van Dongen"Video-based systems that use ... out of its lane are cumbersome and expensive," ...
(Date:4/23/2014)... have developed a way to detect and measure cancer ... particles with tails of synthetic DNA., A team led ... used gold nanoparticles to target and bind to fragments ... variants, which can indicate the presence and stage of ... in a cell can be determined by examining the ...
(Date:4/23/2014)... predict which patients might suffer potentially fatal side-effects from ... assesses brain scans using pattern recognition software similar to ... been developed by researchers at Imperial College London. Results ... which used the software are published in the journal ... 15 million people each year worldwide. Ischemic strokes are ...
(Date:4/23/2014)... In a country as wealthy as the United States, it ... do not have access to adequate food due to lack ... , Recent research at the University of Illinois using ... revealed that the seniors who are dealing with hunger are ... 2011, 8.35 percent of Americans over age 60 faced the ...
(Date:4/23/2014)... the journal Oncotarget , explored tumour heterogeneity ... their own DNA signatures within the same cancer. ... effective, targeted treatment strategies. , Firstly they confirmed ... either the KRAS or BRAF mutation. Secondly, they ... gene mutation have that specific mutation present uniformly ...
Breaking Medicine News(10 mins):Health News:WSU innovation improves drowsy driver detection 2Health News:Gold nanoparticles help target, quantify breast cancer segments in a living cell 2Health News:Airport security-style technology could help doctors decide on stroke treatment 2Health News:Airport security-style technology could help doctors decide on stroke treatment 3Health News:More Americans in their golden years are going hungry 2Health News:Non-uniform genetic mutations identified in lung cancers could lead to targeted treatment 2
... widely believed that people who get married lead a happier ... marriage seems to be more complex than this, according to ... found that marital status has no impact on that general ... tends to stay constant over the years irrespective of whether ...
... link between obesity and cancer, excess body ,weight may contribute ... 14% of all cancer deaths in men. The American Cancer ... ,initially cancer free. By the end of the study, researchers ... weight while controlling for factors such as smoking. Overweight ,and ...
... In a recent survey conducted in the UK most people ... Around 40% of people with asthma develop the condition in ... not recognised and managed in early stages. Asthma can occur ... There also exists a possibility where many people don't realise ...
... Foundation is predicting a 300pc rise in the number of ... this figure is possibly a little high. In a new ... of type two diabetes is to occur. If left untreated ... and kidney failure. It is also estimated that 1m people ...
... stem cells has cured mice suffering with a form ... paralysis of their back legs, and many showed improvement. ... from the brains of adult in the bloodstream or ... cells had migrated to and then repaired damaged areas ...
... World Health Organization said that it should take three to ... China. Since mid-February, an international team from WHO has been ... full partner with China in the investigation of SARS. China ... accounting for about half of the global total. The WHO ...
Cached Medicine News:
... been selling replacement bulbs on ... we are extremely proud of ... out our catalog of replacement ... light bulbs specials. ,Check ...
... Direct has been selling replacement ... 1996, and we are extremely ... guarantee. Check out our catalog ... our discount light bulbs specials. ...
... Direct has been selling replacement ... 1996, and we are extremely ... guarantee. Check out our catalog ... our discount light bulbs specials. ...
... Bulb Direct has been selling ... since 1996, and we are ... satisfaction guarantee. Check out our ... see our discount light bulbs ...
Medicine Products: