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New HIV Entry Inhibitor Program Announced
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"Samaritan Progresses PII/III Study of Novel HIV "Oral" Entry Inhibitor Drug"
Today, Tuesday this company distributed a press release announcing development of HIV entry inhibitors.
The company says this about their drug, on their website:
About SP-01A : Samaritan believes SP-01A cripples HIV's ability to enter cells by blocking the proteins on Human T Cells that would, otherwise, facilitate HIV's entry into those cells. SP-01A is an antiviral adjuvant indicated in the treatment of HIV-infected individuals. In Phase II clinical trials, SP-01A proved itself to be highly effective in significantly reducing viral load and improving quality of life without compromising the health or safety of HIV-infected patients.
SP-01A is an easy-to-take, twice-a-day capsule that is well-tolerated in HIV-infected patients. SP-01A prevents the entry of the HIV virus into target cells by protecting the cells as opposed to combating the virus. For this reason, the virus does not develop resistance to SP-01A. The combination of superior efficacy, the inability of the virus to confer resistance, and a favorable safety profile positions SP-01A as the treatment of choice for (1) treatment na•ve HIV-infected patients; (2) treatment-experienced HIV-infected patients with minimal viral load on stable regimens; and (3) treatment-experienced HIV-infected patients who have failed other therapies due to viral mutations.
Today's NEED FOR SP-10
This compound,SP-10, addresses the needs as described for SP-01A as well as the need for a small molecule. In addition to efficacy and safety, the size of a molecule or compound plays an important role in the treatment of HIV-associated illnesses as well as in the delivery of treatments for HIV-infected individuals. For example, Enfuvirtide (Fuzeonª, Hoffman-La Roche), the first of a new class of HIV treatment therapies called fusion or entry inhibitors, is a peptide (an extremely large molecule) that must be injected in order to be properly absorbed by the body. Its size also contributes to the development of infection at the injection site. Notably, research has specifically shown that brain cells are among the first to be attacked and infected by the HIV virus. However, because the brain is protected by a blood brain barrier (BBB), a highly selective "gatekeeper", and because most approved antiviral treatments are too large to cross the BBB, there is nothing to protect the brain cells from the virus.
Tomorrow's PROPOSED SOLUTION
SP-10 is a small molecule antiviral adjuvant indicated in the treatment of HIV-infected individuals, along with individuals suffering from HIV-associated neurocognitive disorders. In preclinical in vivo studies, SP-10 demonstrated superior or comparable efficacy as an antiviral adjuvant when specifically compared to classic antiviral treatments. Contrasting the classic antiviral treatments, SP-10 repeatedly and effectively inhibited viral replication in every HIV-1 resistant mutant strain tested. Finally, SP-10 provided evidence to be considerably less toxic than the classic antiviral treatments.
UNIQUE ADVANTAGE AND BENEFIT
SP-10 is presently being formulated as an easy-to-take capsule. SP-10 is a small molecule that prevents the access of the HIV virus into target cells by protecting the cells as opposed to struggling with the virus. For this reason, the virus should not develop resistance to SP-10. The combination of superior efficacy, a small molecule size, the inability of the virus to confer resistance, and an encouraging safety profile positions SP-10 as the treatment of choice for (1) treatment na•ve HIV-infected patients; (2) treatment-experienced HIV-infected patients with minimal viral load on stable regimens; (3) treatment-experienced HIV-infected patients who have failed other therapies due to viral mutations; and (4) HIV-infected patients suffering from HIV-associated neurocognitive disorder.
This COMPANY PRESS RELEASE was distributed today.
LAS VEGAS--(BUSINESS WIRE)----Samaritan Pharmaceuticals Inc:
-- Only Small Cap in Race to Be First to Market with Pill to Block AIDS Virus Entry
-- Selected Sites Being Readied to Commence Monotherapy Trial 2Q05
-- Industry Analyst Project a Successful Drug Could Generate Sales as Much as $500-$700 Million a Year
Samaritan Pharmaceuticals Inc. a developer of innovative drugs announced today it is rapidly progressing with its PII/III study of SP-01A, a new kind of pill that, Samaritan believes, blocks the AIDS virus before it ever enters the human cell.
Four sites have been selected to conduct Samaritan's trial for HIV-infected patients experiencing resistance to antiretroviral therapy. In addition, Internal Review Boards responsible for protecting study patients have almost completed their reviews; the Principal Investigators, the Central Lab and Study Monitors are all in place, along with the Study Director, with all anticipating the start of the study.
Dr. Janet Greeson, CEO of Samaritan stated, "When you think about who we are competing against to win, companies like Pfizer, GlaxoSmithKline, Schering-Plough, and being headquarted in Vegas, it makes you feel as though we are playing Texas Hold-em against Big Pharma. If you can imagine, we are holding pocket deuces and they're holding pocket aces, pocket kings, and big slick; none of us know what the flop is going to be and that is the way it is with study trials. Of course, we know we are the underdog but we see the flop as deuce, deuce and an ace and have the perseverance to win; who knows, maybe we will be the next million dollar baby."
About Drug Resistance
It is estimated that some 78% of HIV patients are resistant to at least one of the four classes of HIV drugs; and 50% are resistant to at least two classes. In addition, 10-20% of newly infected patients already have resistance to one or more HIV Drugs.
Samaritan Pharmaceuticals: "A Cure Is Closer Than You Think."
Samaritan, a small Biopharmaceutical company and against all odds, 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. Samaritan's HIV oral, entry inhibitor, drug is projected to enter PII/III clinical trials in 2005.
Visit our Web site at 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 14, 2004. The company undertakes no duty to update forward-looking statements.
Samaritan Pharmaceuticals, Inc. Gene Boyle, 702-735-7001 Fax: 702-737-7016 GeneBoyle@SamaritanPharma.com
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