- A Previous Phase II Study plus Multiple Preclinical Studies Suggest
SP01A as Preventing HIV From Entering the Human Cell
- HIV is Notorious in its Ability to Change or Mutate Which in Itself can
Keep the Current HIV Drugs from Working, Making Drug Resistance the
Most Common Cause of Treatment Failure
- With Encouraging Monotherapy Data Samaritan Plans to Suggest SP01A as a
Drug to Include in 'Salvage Therapy' Hoping to be a Part of Saving the
Lives of HIV Drug Resistant Patients
LAS VEGAS, May 11 /PRNewswire-FirstCall/ -- Samaritan Pharmaceuticals Inc.
(Amex: LIV) a developer of innovative drugs announced today it has officially
initiated a Phase II double-blind, placebo controlled, multi-dose, monotherapy
study in treatment-experience HIV patients. The trial will assess SP01A's
safety and effect on viral load in HIV-1 positive individuals, with evidence
of increasing viral load despite treatment with other antiretroviral therapy.
Dr. Greeson, CEO of Samaritan Pharmaceuticals stated, "Our previous Phase
II study showed SP01A as safe and effective. It also encouraged us to explore
SP01A, as having a new mechanism of action and possibly the first oral entry
inhibitor drug; right now, the only approved FDA entry inhibitor is taken by
injection. Then, with our preclinical studies, SP01A appeared to demonstrate
an activity against multiple HIV strains which gives us so much optimism for
the potential of this drug to help HIV drug resistant patients who are running
out of treatment options."
HIV Monotherapy Clinical Trial Highlights
- The study will enroll 92 patients total in at least 4 groups.
- The treatment groups are placebo, 200mg SP01A daily, 400mg SP01A daily,
800mg SP01A daily.
- The study is expected to start shortly and finish enrollment in about
4 months (September time-frame).
- There is a 4 week wash-out period followed by 10 days of monotherapy
treatment and a 2 week observation period.
- The primary analysis for the study is the reduction in viral load
(log10) in each of the SP01A active and placebo arms, as measured from
Baseline to Study-End.
- Initial draft study results are expected to be available before the end
of the year.
Samaritan Pharmaceuticals: "A Cure Is Closer Than You Think."
Samaritan, a Biopharmaceutical company, is committed to winning the race
to approval for its life-saving affordable drugs. Samaritan, in collaboration
with Georgetown University, is advancing its proprietary compounds for AIDS,
Alzheimer's, Cancer and Cardiovascular disease.
For additional information, please contact:
Samaritan Pharmaceuticals, Inc.
Gene Boyle, 702-735-7001
Fax: 702-737-7016
Email: GeneBoyle@SamaritanPharma.com
Visit our Web site at http://www.samaritanpharma.com.
Disclaimer
The company disclaims any information that is created by an outside party
and endorses only information that is communicated by its press releases,
filings and Web site. This news release contains forward-looking statements
that reflect management's current beliefs about the potential for its drug
candidates, science and technology. However, as with any biopharmaceutical
under development, there are significant risks and uncertainties in the
process of development and regulatory review. There are no guarantees that
products will prove to be commercially successful. For additional information
about the factors that affect the company's business, please read the
company's latest Form 10-K filed April 15, 2005. The company undertakes no
duty to update forward-looking statements.
Available Topic Expert(s): For information on the listed expert(s), click
appropriate link.
Eugene Boyle
http://profnet.prnewswire.com/ud_public.jsp?userid=496296
SOURCE Samaritan Pharmaceuticals Inc.
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Company News On-Call:
http://www.prnewswire.com/comp/158311.html
Related links:
www.samaritanpharma.com
CONTACT:
Gene Boyle, Samaritan Pharmaceuticals, Inc.,
+1-702-735-7001, or fax, +1-702-737-7016,
GeneBoyle@SamaritanPharma.com
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