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VIRxSYS Announces Interim Results from VRX496 Gene Therapy Phase II Trial

Thursday, February 7, 2008 General News
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GAITHERSBURG, Md., Feb. 6 VIRxSYS Corporation, a privatelyheld company developing gene therapies for HIV and genetic diseases, presentedresults from its Phase II trial of VRX496, a gene therapy for the treatment ofAIDS, at the 2008 Annual Conference on Retroviruses and OpportunisticInfections (CROI) in Boston, MA.
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"This appears to be a significant demonstration of slowing and possiblyhalting the replication of the infectious HIV virus in humans," said Dr. GaryBlick, Medical Director, Circle Medical LLC. "VRX496 appears to cause wt-HIVparticles to lose their envelopes and the in vivo pressure delivered by apatient's own modified cells leads to massive quasispecie reductions andproduction of impaired and less replicative virions. This treatment showstremendous promise."
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VRX496 has the potential to change HIV/AIDS care. Currently there are avariety of drugs available for HIV-infected patients, but all have long-termcomplications. To date, there have been no reported adverse events in anypatient receiving VRX496 in clinical trials. In addition, VRX496 does notrequire daily administration.

"We are proving the effectiveness of our lentiviral vector approach inattacking HIV," said Dr. Laurent Humeau, VP of R&D for VIRxSYS. "Ourlentiviral vector VRX496 appears to sustain expression of the RNA antisensetargeting the HIV envelope for a long period of time, with a measurable effecton the HIV replicative fitness up to 3 years following a single injection. Webelieve this will prove to be an important step in the treatment of thisdisease."

VRX496 is a different viral vector than those used in previous genetherapy trials. VRX496 is derived from HIV-1 itself and has it disease-causingelements removed. Currently, VRX496 is being investigated as a therapeutictreatment (a treatment for those already infected with HIV). Unlike otherviral vectors, lentiviral vectors appear to sustain expression of thedelivered genes of interest for a longer period of time. Their safety profilesare currently being evaluated in clinical trials.

"These results are everything we've been hoping for," said Dr. RikuRautsola, CEO and President of VIRxSYS. "VRX496 is a remarkably promisingtreatment for HIV. We are very excited about what we are seeing so far in ourtrials and are confident that these results will continue into Phase III."

The VIRxSYS results were presented at CROI on Tuesday, February 5th from1-4 PM at session 124 in Hall A. The VIRxSYS poster was number 753.

About VIRxSYS

VIRxSYS is a private biotechnology company using proprietary lentiviralvector delivery and RNA payload platforms to develop therapies for serioushuman diseases. The Company's initial lentiviral delivery technology wasexclusively licensed from The Johns Hopkins University and has beensubstantially advanced in the Company's laboratories. The RNA payloadtechnology was acquired and has been integrated with the Company's lentiviraldelivery technology. In addition to preclinical programs for genetic and otherserious diseases, the Company is currently developing gene and vaccinetherapies for HIV, one of which has advanced to Phase 2 human clinical trials.More information regarding VIRxSYS can be found at www.virxsys.com. Detailsfor the Phase II study can be found at the NIH clinical trials website atclinicaltrials.gov/show/NCT00131560.

Contact: Paul Gibney

Phone: (212) 255-5340

E-mail: [email protected]

SOURCE VIRxSYS Corporation
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