Samaritan Readies Promising HIV Drug to Move into Late-Stage Clinical Trials
Tuesday January 11, 8:01 am ET
LAS VEGAS--(BUSINESS WIRE)--Jan. 11, 2005--Samaritan Pharmaceuticals Inc. (AMEX:LIV - News):
HIV Drug SP-01A (sPHirewall technology) Appears to Stop Viral Entry Early in the Infection Process Even Before Fusion Inhibitors Making It an Excellent Candidate to Combat HIV Drug Resistance
Drug Resistance Remains the Single Most Important Reason for Virologic Failure and Rapidly Limits a Patients Treatment Options
Samaritan Pharmaceuticals Inc. (AMEX:LIV - News) a developer of innovative drugs announced today their most recent drug development accomplishments in readying their proprietary HIV drug SP-01A to move into late-stage clinical trials.
Samaritan has spent the past year, and still is conducting the FDA required preclinical, in vitro, in vivo studies, for its HIV drug SP-01A as antiviral drug. All of the below data has been presented to the FDA and others are being readied to present to the FDA to move forward into late-stage clinical trials.
Dr. Janet Greeson, CEO of Samaritan Pharmaceuticals stated, "We are truly grateful to the Georgetown University scientists for digging in and expediting this process to get to this milestone."
Clinical Trial Developments Presented to the FDA
Presented data from Samaritan's Phase Ib/IIa trial, a dose-escalating trial designed to evaluate the antiviral effects and safety of SP-01A, Samaritan's lead drug candidate for HIV-infected patients.
Presented Monotherapy protocol using SP-01A for failing treatment-experienced HIV-infected patients.
In the process of site selection, a central lab and study monitors for Monotherapy trial. Barring difficulty, patient enrollment for this trial is currently expected to start by the second Quarter of 2005.
Preclinical Studies Presented to the FDA
In vitro and in vivo studies have provided Samaritan with useful information in the designing of our planned late-stage clinical trials and helped us to analysis and predict SP-01A's role in the development of resistant viruses. Of the numerous studies completed and under way, the following studies have given Samaritan reason to move forward with SP-01A and supports its sPHirewall technology thesis,
-- Presented a "Mechanism of Action" study to the FDA.
Samaritan has a growing body of preclinical data suggesting
SP-01A as an Entry Inhibitor. Data suggests that SP01A reduces
HIV-1 virus replication by interfering with
cholesterol-dependent regulation mechanisms that permit the
HIV-1 replication, rendering therefore even impossible for the
virus to enter and infect the cell.
Click link to review peer review journal:
samaritanpharma.com
jpet.aspetjournals.org
The following confidential preclinical studies were presented to FDA and data will be disclosed upon publication.
Anti-HIV-1 Replication Activity Studies
Cell entry inhibition Studies
In Vitro Viral Replication Studies
In Vitro Cytotoxicity Studies
Samaritan Pharmaceuticals: "A Cure Is Closer Than You Think."
Samaritan is innovation-driven and focuses on the clinical advancement of its pipeline of novel drug discoveries. Samaritan's mission is to help cure and ease the suffering of patients with AIDS, Alzheimer's, Cancer and Cardiovascular disease with affordable drugs.
Visit our Web site at www.samaritanpharma.com |
