Development of Koronis Pharmaceuticals’ KP-1461, an experimental antiretroviral (ARV), has been suspended after an analysis of existing data failed to show anti-HIV activity, according to a report by Project Inform. These results came as a surprise to Koronis and stand in contrast to the drug’s earlier lab studies that showed promise.
Though KP-1461 is technically a nucleoside reverse transcriptase inhibitor (NRTI), its mechanism of action is quite different from other drugs in this class of ARVs. Whereas current NRTIs are incorporated into developing DNA to stop the chains of genetic material from becoming fully formed and infectious, the integration of KP-1461 into developing chains of viral DNA causes the virus to produce defective, harmless versions of itself.
The U.S. Food and Drug Administration (FDA) had asked Koronis to do some additional lab studies to determine if HIV becomes resistant to KP-1461. During these lab studies, Koronis found that the drug had no measurable effect on HIV, a stark contrast to earlier studies that supported the drug’s clinical development. With the new results in hand, Koronis then analyzed blood samples from people enrolled in its ongoing clinical trial and, to their surprise, again found no anti-HIV activity.
Stephen Becker, MD, the lead investigator for Koronis, told Project Inform that the company is, “committed to understanding these discordant results and will attempt to validate the original 2002 research,” on KP-1461. Becker estimated that it will take at least two months to fully investigate this setback, and determine what comes next.
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comments 1 - 6 (of 6 total)
Lynette, Johannesburg, 2008-07-05 15:08:48
On behalf of LYNETTE
I'm 43yrs,female South African with HIV 5yrs now. CD count at 0 sometimes. Family revives me with CELLFOOD OLIVE LEAVE TINCTURE & MANGOSTEEN but can hardly afford it - I don't work, have a huge liver and a disfigured body and face from constant puss pimples. Please Help I need to sign on for Trial RALTEGRAVIR/ISENTRESS-do I qualify as a candidate or where can I sign on please?
I made it this far and I have so much to live for please help........God bless
Lynette
Jessica, , 2008-06-26 02:00:28
Someone suspect that Koronis presented false result to FDA (serial passagges to extinguish the virus ). If this is confirmed it will be not possible to trust anymore to FDA.
I remember what said Stephen Becker. Several series of in vitro experiments were done in cell cultures, using a very nasty strain of IV ( not HIV ? )After an average 15 serial passages, that virus was irreversibly extinguished -- repeatedly. Repeated, published experiments have demonstrated that you can collapse the hiv
paul, , 2008-06-20 06:09:17
I just got a confidential report from MIT in Boston.
In few words
The scientitist that were more involved -MIT- when the drug was invented, the chemistry phase, confirm that the kp-1212-1461,the 5-substituted cytosine, does extinguish HIV. They are very happy that the company is pushing ahead and they are pleased with the excellent safety profile for KP-1461 and
clinical results that show only occasional mild to moderate drug-related
adverse.
paul, , 2008-06-19 05:44:30
They asked the people, in a very bad condition, to stop 16 weeks the haart for which reason? to be enrolled in a trial to test a drug that is like water? IF yes .. it is crime. I think there is something really strange in all this "stuff".
I m looking forward for more deeply details from Koronispharma.
paul, , 2008-06-18 10:19:41
There has to be a twist.
It is not possible that FDA permit a clinical trial phase 2 for a hiv drug that is simple water. It is not possible at all.....FDA must have required all the possible datas before giving green light to Koronis for humans trial..There has to be a twist.
What about the pacific ventures funds? Big job for the lawyer on the horizon ?
johnny1, , 2008-06-18 02:33:38
In the projectinform report is written that few people experienced significant reductions in their HIV levels. Few people is completely different than no people. It means that kp-1461 in some(few people ) can really controll the hiv replication.
The mechanism's theory is valid, it is a matter of finding the correct chemical structure to be inserted into the virus' life cycle.
Beth Benne, RN, is HIV negative, but
the virus has impacted her life. She currently supervises a biannual HIV/AIDS awareness week as
the director of the student health center at Pierce College, a
community commuter school in Woodland Hills, California.
Woman of the Month is supported by exclusive advertising from Gilead.
Overheard in the Women's Forum
"I recently met a guy who is negative. I did tell him about my status and he decided to kiss me anyway (we didn't go further than that). But a day later, he called and said that he actually had a mouth ulcer that time when we kissed and he was very worried. Asked if he can get the virus from me that way. For that moment, I felt so insulted and yet I felt so bad. It was my first time having a contact with a "negative" guy."
