Samaritan Starts Enrolling for Its PII Stage 2 (28 Day Monotherapy) Study of ''Oral'' Entry Inhibitor SP-01A
02 5์ 2006 - 10:15PM
Business Wire
Samaritan Pharmaceuticals (AMEX:LIV): -- Completed Phase II Stage 1
(10 Day Monotherapy) -- Expect to Report Stage I Preliminary
Results at Shareholders Meeting May 31st -- Expect Final PII Stage
I Report July -- Currently Enrolling Phase II Stage 2 Samaritan
Pharmaceuticals Inc. (AMEX:LIV) a developer of innovative drugs,
announced today, it completed a Phase II Stage 1 (10 day
monotherapy study) with 34 patients in which SP01A was being
evaluated as an adjunct therapy for treatment-experienced HIV
patients who are failing on their current anti-viral therapy.
Samaritan also notes it has started enrolling for its Stage 2 (28
day monotherapy trial) and numerous Stage 1 evaluates are rolling
over to Stage 2 which will count toward the 60 evaluates Samaritan
intends to enroll for the Phase II Stage 2. Dr. Janet Greeson, CEO
of Samaritan stated, "Completing this 10 day HIV monotherapy study
of SP01A is a significant milestone in its clinical development. We
anticipate locking the data from this study at the end of this
month and with a bit of luck will report preliminary results at the
shareholders meeting, May 31, 2006. We expect to submit the (10 day
monotherapy) final report to the FDA in July 2006. We remain
resilient in advancing SP01A through FDA clinical trials hoping it
might serve as a life-saving drug for HIV drug resistant patients."
Previously Completed Trial Phase I/II Proof of Concept Study: An
8-week, Phase I/II study, conducted at AIDS Research Alliance in
Hollywood, CA, was concluded and reported in July of 2003. SP01A
was associated with reductions in HIV-1 viral load in patients with
measurable HIV-1 in a dose dependent manner. In the high dose
group, mean HIV-1 viral load reduction of 1.34 log10 copies/ml was
observed; 100% of the patients achieved HIV-1 viral loads below the
limit of detection and a greater than 1.0 log reduction was
observed in 80% of the patients by Week 8. This level of reduction
in viral load is clinically relevant, particularly since patients
continued on background antiretroviral therapy throughout the
clinical trial. Consistent with a treatment effect of SP01A, HIV-1
viral load measurements showed a rebound increase when high dose
SP01A treatment was discontinued. For more information on this
clinical trial, please go to the FDA Clinical Trials Website at
www.clinicaltrials.gov. Samaritan Pharmaceuticals: "We LIV....to
Save Lives." Samaritan is a small-cap Biotech, driven to discover,
develop, and commercialize, innovative therapeutics' for AIDS,
Alzheimer's, Cancer and Heart disease. Look at
www.samaritanpharma.com. Please register on Website so we can
notify you of upcoming conference calls, news and events.
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 Website. 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. NOTE TO EDITORS: in the term "log10"
the 10 is subscript. It was changed for transmission purposes only.
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