>> C'mon you AGPHite's...what do we make of this news? Is their drug a potential blockbuster of any kind? <<
Of course. The question has always been, will it work?
AGPH loses $12 million upfront. Quite respectful for a 50:50 deal. This is pretty interesting. I need some digestion time, but, for active immunization of infected patients, I lean toward efforts with a whole virus.
"Europe and certain other countries?" That would imply that we could see fireworks later this month. AGPH is acting as JT, 50:50, if you like. So...... here's the key..... "Prominent among these data were encouraging preliminary results from a small study of REMUNE taken in combination with highly active antiretroviral drugs -- results that will be presented at the upcoming 12th World AIDS Conference in Geneva later this month."
I used to criticize IMNR, believing that an inactivated virus would never be used in naive patients. However, it seemed very reasonable to attempt to immunize virus-positive patients in combination with HAART. Let us not forget, however, that attempts to immunize antigen-(viral-)positive patients, shades of old Cytel and HBV, are controversial. I'll post the "Walker" abstract in my next post.
What has AGPH done? They've guaranteed that, if active vaccination in virus-positive patients is proven to be beneficial, they'll be a dominant player in HIV. Please, Dear George Rathman, manage a DMP-266 alignment. Johnson is playing $12 million (plus) for a chance to call the shots for the foreseeable future. This is a "limit the downside, leverage the potential" play. I suspect that it's only a part of what's going on.
The vaccine is sort of the exact opposite of the GNE vaccine (VacTex, or whatever the spinoff is called).......
Vaccine 1998 Jan;16(2-3):119-129
Characterization of highly purified, inactivated HIV-1 particles isolated by
anion exchange chromatography.
Richieri SP, Bartholomew R, Aloia RC, Savary J, Gore R, Holt J, Ferre F, Musil R, Tian HR, Trauger R, Lowry P,
Jensen F, Carlo DJ, Maigetter RZ, Prior CP
Immune Response Corporation, King of Prussia, PA 19406, USA.
[Medline record in process]
This report characterizes inactivated, gp120 depleted, HIV-1 particles purified by an anion exchange chromatography
production process. This antigen formulated with incomplete Freund's adjuvant constitutes Remune, which is being evaluated in
a phase III clinical endpoint trial to determine the effect of this immune-based therapy on clinical progression of HIV-1
seropositive patients. Multiple production lots of the inactivated HIV-1 antigen strain HZ321, isolated by anion exchange
chromatography, exhibit purity of > 95% by gel filtration. These findings are corroborated by thin section electron microscopy
showing a homogenous field of intact particles. Analyses of the purified virus particles for protein, lipid, carbohydrate and RNA
show structural retention of the envelope proteins, lipid bilayer and core components after large scale processing. The
qualitative identification of at least 85% of total HIV-1 protein is determined by ELISA, Western blot, HPLC and amino acid
sequencing analyses. Quantitative values are assigned to 50% of these proteins. The data confirm the presence of virally
encoded proteins p6, p7, pI15, p17, p24, p32, pI39Gag, gp41, pp55Gag, p66/51, Vpr, Vif and Nef. Excellent consistency
between production lots and equivalency to HIV-1 preparations purified by sucrose density gradient sedimentation has been
established for protein and lipid composition, and overall purity. These findings further establish that non-viral encoded proteins
and lipids are integral structural components of the intact virion and are not contaminants unique to a particular isolation method.
The data confirm the presence of multicomponent antigens in the viral particles for stimulating a broad HIV-1 specific immune
response. Finally, the work demonstrates that the two inactivation procedures (beta-propiolactone and gamma irradiation),
which achieve efficient viral inactivation meeting US FDA guidelines, do not damage the protein antigens of the viral particles.
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