Navigation Links
Interim Analysis of Phase I/II Study of Rexin-G Confirms Efficacy With No Dose Limiting Toxicity in Metastatic Pancreatic Cancer
Date:4/21/2008

Second Phase Opens With Higher Dose Regimens

SAN MARINO, Calif., April 21 /PRNewswire/ -- Epeius Biotechnologies Corporation announced today that Interim Analysis of an on-going Phase I/II study of Rexin-G for pancreatic cancer confirmed Rexin-G's anti-tumor activity with no major toxicity in patients with metastatic chemotherapy-resistant pancreatic cancer. The clinical trial design includes 5 escalating doses of intravenous Rexin-G ranging from 1 x 10e11 cfu twice a week to 4 x 10e11 cfu three times a week for 4 weeks. Treatment cycles are repeated if the patient exhibits Grade 1 or less toxicity. Interim analysis showed no dose limiting toxicities in 9 evaluable patients who received Dose Levels 1-3. Furthermore, the analysis showed decrease in tumor size or disease stabilization (by RECIST), decreased metabolic activity in tumors (by PET-CT scan), reduction in tumor marker levels, and clinical benefit in patients receiving Dose Level 3. The second phase of the Rexin-G study has now opened wherein six patients will receive Dose levels 4 and 5, respectively, as the Phase I/II adaptive study design continues to evaluate the over-all safety of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the clinical benefits required to support a Phase II/III pivotal trial.

*(LOGO: Send2Press.com/mediaboom/08-0421-Epeius_72dpi.jpg)

According to Dr. Sant P. Chawla, Principal Investigator of the Phase I/II study, "I am happy with the positive results of Rexin-G seen in pancreatic cancer, and look forward to obtaining even better results with progressively higher doses of Rexin-G." Dr. Chawla is currently conducting three Los Angeles-based Phase I/II clinical trials using Rexin-G in sarcoma, pancreatic cancer, and breast cancer, and a Phase II study of Rexin-G for osteosarcoma. For further information concerning these clinical trials, please contact Dr. Erlinda M. Gordon at egordon@epeiusbiotech.com.

Rexin-G(R) is the world's first and so far only targeted injectable genetic medicine that has been validated in the clinic (Nature Reviews/Genetics 2007). Injected intravenously, the targeted nanoparticles are designed to seek out and destroy both primary tumors and metastatic cancers that have spread throughout the body. The FDA has granted Orphan Drug Status for Rexin-G for the treatment of pancreatic cancer while the Philippine BFAD has granted accelerated approval of Rexin-G for the treatment of all solid tumors that are resistant to standard chemotherapy.

About Epeius Biotechnologies

Epeius Biotechnologies Corporation is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its proprietary targeted delivery systems. Credited with innovations ranging from oncogene discovery, to designer therapeutic genes, to pathotropic (disease-seeking) targeting, to high-performance vector engineering, advanced biopharmaceutical manufacturing and bioprocess development, Epeius Biotechnologies is well positioned to "launch" its enabling platform technologies for the benefit of cancer patients worldwide. To learn more about Rexin-G and Epeius' pipeline of proprietary compounds currently available for partnership or clinical trials, please visit: http://www.epeiusbiotech.com.

This release was issued on behalf of the above organization by Send2Press(R), a unit of Neotrope(R). http://www.Send2Press.com


'/>"/>
SOURCE Epeius Biotechnologies Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Medarex Reports Interim Data from Ongoing Ipilimumab Combination Phase 1 Studies in Prostate Cancer at American Association for Cancer Research Meeting
2. Nventa Announces Positive Interim Immunological Data From HspE7 Phase 1 Cervical Dysplasia Trial
3. NanoBio Corporation Completes Interim Analysis of Phase 2 Clinical Trial in Onychomycosis
4. Independent Data Safety Monitoring Board Recommends Continuation of Sangarts Pivotal Phase III Trials of Hemospan(R) Following Second Interim Review
5. Sunesis Pharmaceuticals Reports Positive Interim Data for SNS-595 Single-Agent Activity in Platinum-Resistant Ovarian Cancer
6. NanoBio Corporation Presents Preclinical and Interim Clinical Data on Topical Treatments for Herpes Labialis and Onychomycosis at AAD 2008
7. Interim Analysis Supports Continuation of Cell Genesys VITAL-1 Phase 3 Clinical Trial of GVAX Immunotherapy for Prostate Cancer
8. Interim Safety Analysis Supports Continuation of Allos Therapeutics Pivotal Phase 2 PROPEL Trial of PDX in Patients with Peripheral T-cell Lymphoma
9. Novavax Announces Favorable Interim Results from Human Clinical Trial for Its Pandemic Influenza Vaccine Program
10. Grantees of the Avon Foundation Breast Cancer Prevention Research Initiative Gather in Houston to Report Interim Findings
11. Leading Physicians Present Interim Results from Multi-Center Studies of VNUS ClosureFAST Catheter at VEITHsymposium
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/20/2017)... PARIS , April 20, 2017 ... EyeCET platform, the first non-viral gene expression technology that ... in the eye to address a wide range of ... UK Medicines and Healthcare products Regulatory Agency (MHRA) to ... ...
(Date:4/19/2017)... , April 19, 2017 The Mobile X-Ray ... showcase a healthy CAGR during the forecast period ... in the global digital mobile X-Ray devices market, which is ... in 2017, expanding at a CAGR of 7% over the ... $ opportunity of more than US$ 100 Mn in 2017 ...
(Date:4/19/2017)... -- The Global Effective Microorganisms (EM) Market by ... covered and analysed the potential of Global Effective Microorganisms (EM) ... and growth factors. The report identifies and analyses the emerging ... global market. ... Tables and Figures, 6 Major Company Profiles, spread across 124 ...
Breaking Medicine Technology:
(Date:4/21/2017)... ... April 21, 2017 , ... Young Asset Protection, an insurance ... throughout the greater Pittsburgh metropolitan region, is joining forces with the local chapter ... differently-abled children. , Variety the Children’s Charity is a national organization dedicated to ...
(Date:4/21/2017)... ... April 21, 2017 , ... The adage “Show, don’t tell” ... next project in the company’s esteemed VISION House demonstration project series. Manifesting the concept ... amount of resources they need to live affordably and abundantly without unduly taxing the ...
(Date:4/21/2017)... ... April 21, 2017 , ... The VIA Agency , ... for Theravent, Inc. , the makers of a revolutionary new device clinically ... is now working to expand distribution in anticipation of a national launch. VIA ...
(Date:4/21/2017)... ... April 21, 2017 , ... Crossover Symmetry ... O2X , an active lifestyle company that provides Human Performance Training and education ... police offers, first responders, military officers and others in service through the development ...
(Date:4/21/2017)... ... 21, 2017 , ... Alive for Wellness is a group of ... health struggles. The Alive team uses advanced behavioral sciences treatment modalities to accomplish ... a mental health struggle is based on 10 modalities of treatment that ...
Breaking Medicine News(10 mins):