By ANI
London, February 11(ANI): The virus used in the vaccine that helped eradicate smallpox is offering new hope to liver cancer patients.
Researchers have found that a genetically engineered version of the vaccinia virus tripled the average survival time of people with a severe form of liver cancer, with only mild, flu-like side effects, according to the New Scientist.
Thirty people with hepatocellular carcinoma received three doses of the modified virus - code-named JX-594 - directly into their liver tumour over one month. Half the volunteers received a low dose of the virus, the other half a high dose.
Results showed that members of the low and high-dose groups subsequently survived for, on average, 6.7 and 14.1 months respectively.
Two of the patients on the highest viral dose were still alive more than two years after the treatment.
As well as shrinking the primary tumour, the virus was able to spread to and shrink any secondary tumours outside the liver.
"Some tumours disappeared completely, and most showed partial destruction on MRI scans," noted David Kirn, head of the study at Jennerex. Moreover, the destruction was equally dramatic in the primary and secondary tumours.
The fact that the virus appears able to spread to secondary tumours suggests that simply injecting the virus into the bloodstream may be effective.
A trial to compare this treatment with injecting the virus directly into a tumour is under way.
Fischer said that until now, more than 200 people have received the virus, which has also shown promise against other types of cancer, including those of the kidney and skin.
But he warns that not everyone sees a benefit.
Source
Press Release
Jennerex Announces Nature Medicine Publication
HighlightingRandomized Overall Survival Benefit of Lead Product
Candidate,Pexa-Vec (JX-594) in Patients With Advanced Hepatocellular
Carcinoma(HCC)
High-Dose Pexa-Vec Associated With Statistically Significant
Improvement in Median Survival Versus Low-Dose Pexa-Vec (14.1 Months vs. 6.7
Months)
SAN FRANCISCO, CA, Feb 10, 2013 (Menafn - MARKETWIRE via COMTEX)
--Jennerex, Inc., a private, clinical-stage biotherapeutics companyfocused on
the development and commercialization of best-in-classtargeted oncolytic
immunotherapies for solid tumors, today announcedthe publication of research
demonstrating the ability of its leadproduct-candidate, Pexa-Vec (JX-594) to
significantly prolongsurvival in advanced hepatocellular carcinoma (HCC)
patients in arandomized dose comparison clinical trial. This research,
publishedin Volume 19, Issue 2 of Nature Medicine, showed a
statisticallysignificant dose-dependent overall survival benefit with 14.1
monthsmedian overall survival for the high-dose group compared to 6.7months for
the low-dose group (p-value = 0.02). This is the firstrandomized clinical trial
of an oncolytic immunotherapy demonstratingsignificantly prolonged overall
survival.
Pexa-Vec is an oncolytic immunotherapy designed to 1) rapidly
de-bulktumors via tumor cell lysis, 2) activate an antivascular effect withrapid
tumor vascular knockout, and 3) induce a durable immuneresponse against tumors.
Pexa-Vec was engineered from vaccinia, whichhas been used for decades as a
vaccine in healthy individuals.Pexa-Vec has been safely administered to over 200
patients and iscurrently in Phase 2b clinical development for the treatment
ofadvanced HCC and is also being evaluated in other solid tumors.
"The treatment options for advanced HCC are limited, with
fewpromising agents currently in development. This Nature Medicinepublication
highlights the unique possibility of a meaningfulsurvival benefit combined with
short-term, transient and manageableside effects," said Tony Reid, M.D., Ph.D.,
professor of Medicine atUniversity of California, San Diego and co-lead author
of the paper."The findings also showed Pexa-Vec's ability to induce
anti-tumorimmunity and reduce blood flow to tumors which supports
Pexa-Vec'smulti-pronged approach to attacking cancer."
The data presented in the Nature Medicine publication showed
thatPexa-Vec had clear local anti-cancer response at both the low andhigh doses.
Thirty subjects were randomized into the low and highdose groups and received
three Pexa-Vec treatments over the course offour weeks. The results demonstrated
that Pexa-Vec treatment at bothdoses resulted in a reduction in tumor size and
decreased blood flowin tumors. The data further demonstrates that Pexa-Vec
treatmentinduced an immune response against the tumor, evidenced
byantibody-mediated tumor cell toxicity. Pexa-Vec was well-tolerated atboth high
and low doses with the most frequent adverse eventsconsisting of fever lasting
less than 24 hours.
"This Nature Medicine publication validates our clinical data
and thescientific rationale for our approach to treating cancer withoncolytic
immunotherapy as well as the continued development ofPexa-Vec for the treatment
of HCC and other solid tumors," saidLaurent Fischer, M.D., president and chief
executive officer ofJennerex. "The opportunity to rapidly de-bulk tumors and
provide along-term immune effect is a significant advance in the treatment
ofHCC. We are currently enrolling patients in multiple mid andlate-stage trials
with Pexa-Vec with the goal of bringing thisgroundbreaking therapy to
market."
Pexa-Vec Clinical Development Program and SOLVE Platform
Pexa-Vec(JX-594) is currently being evaluated in an international,
randomizedPhase 2b clinical trial (TRAVERSE) in patients with advanced
primaryliver cancer who have failed sorafenib therapy. It is also beingtested in
HCC patients in combination with sorafenib. In addition,Pexa-Vec is being
evaluated in a Phase 1-2 clinical trial in patientswith treatment-refractory
colorectal cancer as monotherapy and incombination with irinotecan.
Phase 1 and Phase 2 clinical trials in multiple cancer types to
datehave shown that Pexa-Vec, delivered either directly into tumors
orintravenously, induces tumor shrinkage and/or necrosis and iswell-tolerated
(over 200 patients treated to date). Objective tumorresponses have been
demonstrated in a variety of cancers includingliver, colon, kidney, lung cancer
and melanoma. Pexa-Vec has had apredictable and manageable safety profile to
date which includesflu-like symptoms that resolve in 24 to 48 hours.
Pexa-Vec is the lead product candidate from Jennerex'
SOLVE(TM)platform, a groundbreaking approach offering new therapeutic optionsfor
patients with life-threatening cancers. SOLVE builds on thenatural attributes of
vaccinia viruses to engineer highly targeted,oncolytic immunotherapies for
cancer with minimal side effects.
About Jennerex's Regional Partners for Pexa-Vec Transgene
(nyseeuronext paris:FR0005175080), a bio-pharmaceutical companyspecialized in
the development of immunotherapeutic products, holdsan exclusive license to
develop and commercialize Pexa-Vec in Europeand neighboring countries. Green
Cross Corporation, a leading companyin the development, manufacturing, and
commercialization of viralvaccines and other biological products, holds an
exclusive license todevelop and commercialize Pexa-Vec in South Korea, and
Lee'sPharmaceutical Ltd. holds an exclusive license to develop andcommercialize
Pexa-Vec in China.
Transgene, a member of the Institut Merieux Group, is a
publiclytraded French biopharmaceutical company dedicated to the developmentof
therapeutic vaccines and immunotherapeutic products in oncologyand infectious
diseases. Transgene has four compounds in phase 2clinical development: TG4010
and Pexa-Vec (TG6006) having alreadycompleted initial phase 2 trials, TG4001 and
TG4040. Transgene hasconcluded three strategic agreements for the development of
itsimmunotherapy products: an option agreement with Novartis for thedevelopment
of TG4010 to treat various cancers; an in-licensingagreement with US-based
Jennerex, Inc. to develop and market Pexa-Vec(TG6006), an oncolytic virus, and
with the EORTC for the developmentof TG4001 to treat HPV induced head and neck
cancers. Transgene hasbio-manufacturing capacities for viral-based products.
Additionalinformation about Transgene is available at www.transgene.fr.
Green Cross Corp. is a publicly traded and leading
Koreanbiopharmaceutical company specialized in development andcommercialization
of vaccines, plasma-derivatives, recombinantproteins and therapeutic antibodies
in oncology and infectiousdiseases. Green Cross Corp. has been collaborating
with Jennerex inKorea since 2006 to jointly conduct the Phase 1 and 2 clinical
trialsin patients with liver cancer. Additional information about GreenCross
Corp. is available on the internet at www.greencross.com.
Lee's Pharmaceutical Holdings Limited is a
research-basedbiopharmaceutical company listed in Hong Kong with over 19
yearsoperation in China's pharmaceutical industry. It is fully integratedwith
strong infrastructures in drug development, manufacturing, salesand marketing.
It has established extensive partnership with over 20international companies and
currently has 14 products in the marketplace. Lee's focuses on several key
disease areas such ascardiovascular, oncology, gynecology, dermatology and
ophthalmology.Lee's development program is lauded with 30 products stemming
fromboth internal R&D efforts and collaborations with US, European
andJapanese companies and aspiring to combat diseases such as livercancer and
pulmonary hypertension. The mission of Lee's is to becomea successful
biopharmaceutical group in Asia providing innovativeproducts to fight diseases
and improve health and quality of life.Additional information about Lee's
Pharmaceutical is available atwww.leespharm.com.
About Jennerex Jennerex, Inc. is a clinical-stage
biotherapeuticscompany focused on the development and commercialization
ofbest-in-class, breakthrough targeted oncolytic immunotherapy productsfor
cancer. The Company is focused on two main programs, lead productcandidate,
Pexa-Vec (JX-594), which is in mid-stage clinicaldevelopment for the treatment
of advanced primary liver cancer andcolorectal cancer and JX-929 which is under
investigation for avariety of solid tumors. Jennerex is headquartered in San
Franciscoand has related research and development operations in Ottawa,
Canadaand Busan, South Korea. For more information about Jennerex, pleasevisit
www.jennerex.com.
Media Contact:
Nicole Foderaro
BrewLife
415-946-1058
Email Contact
Nicole Foderaro
BrewLife
415-946-1058
Email Contact
SOURCE: Jennerex
