“The data we are presenting this week furthers our belief that VRX496, our lentiviral vector- based gene delivery system, is safe,” said Riku Rautsola, PhD, President and CEO of VIRxSY S. “We have administered as many as 78 billion transduced cells to patients without any treat ment associated adverse events. The results presented here are the first safety data available on the human administration of lentiviral vectors. We are proud that we can share such important n ews at this prestigious conference.” VIRxSYS will be presenting at the poster session on Wednesday, September 18 at 12:15 pm. Successful results of a Phase I study of VRX496 have previously been reported (Levine et al. P NAS 2006). In ongoing Phase II clinical trials for VRX496, VIRxSYS has treated a total of 24 pat e bolus infusions ranging from 10 to 30 billion cells per dose. To date, this trial has demonstra ted the safety and tolerability of multiple infusions and larger bolus infusions. These patients a re currently being monitored to determine the optimal treatment regimen for patients. About VIRxSYS Founded in 1998, VIRxSYS is a private biotechnology company that focuses on the development of a n ovel lentiviral vector platform technology for the treatment of serious diseases such as HIV/AIDS, ca rdiovascular disease and hemophilia. The Company has exclusively licensed its patented, proprietary t echnology platform from The Johns Hopkins University (JHU) in Baltimore, Maryland where the origin al research was conducted. The Company also has been issued additional patents relating to the appl ication and manufacture of the technology. More information regarding VIRxSYS can be found at www. virxsys.com. Details for the Phase II study may be found at the NIH clinical trials website at clinicalt rials.gov/show/NCT00131560. A full press kit is available by emailing: [email protected].
VIRxSYS has now accumulated 65 patient-year of data on human administration of VRX496. バイレクシスは現在、VRX496の人体への投与に関し、延べ65患者のデータを蓄積しました。
Five patients in Phase 1 have been followed for three to four years without serious adverse events. フェーズ1を受けた5人の患者さんにおいてはすでに3〜4年の追跡チェックが行われていますが、 そこでは、一切の重大な副作用(悪化)は発生していません。
In Phase2, 24 patients have been followed for nine months to one year, and safety monitoring is ongoing. フェーズ2を受けられた24人の患者さんについても、すでに9ヶ月〜1年の追跡チェックが行われており、 その安全性へのチェックは現在も続行中です。
The data we are presenting this week furthers our belief that VRX496, our lentiviral vector-based gene delivery system, is safe. 今週われわれが発表したデータは、当社のレンチウイルスベクターを使った遺伝子 デリバリーシステムであるVRX496の安全性をさらに確信させるものでした。
We have administered as many as 78 billion transduced cells to patients without any treatment associated adverse events. われわれは、副作用(悪化)に起因する処置は、一切、施すことなく、一人の患者さんに最大で 780億個の組み換え細胞(transduced cells)を投与してました。
The results presented here are the first safety data available on the human administration of lentiviral vectors. 今回のわれわれの発表は「レンチウイルスベクターの人体投与における安全性」に関する(世界で)最初の有効データです。
In on going Phase2 clinical trials for VRX496, VIRxSYS has treated a total of 24 patients with multiple-doses of VRX496, with half the patients receiving four doses of the therapy, and the other half receiving eight and 16 patients with single 株価100倍は現実へ?
bolus infusions ranging from 10 to 30 billion cells per dose. 現在進行中のVRX496の治験のフェーズ2において、バイレクシスは、24人の患者さんに対してVRX496の複数投与 (半数の12人は4回投与、残りの半数の12人は8回投与)を、そして、16人の患者さんに対して一回投与 (一回の投与が100億〜300億細胞)を実施いたしました。
To date, this trial has demonstrated the safety and tolerability of multiple infusions and larger bolus infusions. 今までのところ、このたびの治験は、複数投与と拡大一回投与に関するVRX496nの安全性と許容性(torelability)を示しています。
These patients are currently being monitored to determine the optimal treatment regimen for patients. これらの患者さんは現在も、それぞれの患者さんにとっての最適追治療方法(最適投与量のことか?) 見つかることを目標にさらに追跡チェックを受けています。