tomorrows news today, page-15

Stocky, one thing you cited was Gamma Globulin. Forgot about that. I have posted this before, but here is what I have on it. You are right and Baxter have their Gammagard in human trials phase3 funded by NIH. If approved I think it would be more of a problem for Bapi, figures for PBT2 so far show it superior.

Gammagard and Bapi are infusions and PBT2 a pill.

If Baxter can repeat the results in their 18 month phase2 in their current phase 3 I think it has to be approved. At 18 months patients on Gammagard declined 9.15 less than the Placebo in patients who recieved uninterrupted GAMMAGARD for a period of 18 months.

The original PBT1 did similar at 84 weeks after only 36 week trial.

[The outperformance of PBT1 continued well beyond one year. An openlabel extension study beyond the original 36 week trial period studied patients out to week 84, with results announced by PBT in October 2004. By this stage the notional ADAS-cog gap between treated and untreated had
widened to 10 points, so that while the treated patients were still declining cognitively, PBT1 appeared to have cut the expected rate of disease progression in half.]
From SCE analyst report on www.Pranabio.com web site.


By Bob DeMarco
Alzheimer's Reading Room

Alzheimer's disease patients treated with Baxter International's (BAX.N) Gammagard for 18 months:

Showed better cognitive function and less brain enlargement than those given a placebo.
Patients with mild to moderate Alzheimer's disease who received the intravenous medication in a Phase II study averaged about 1.36 points higher than patients who initially received a placebo on a test of mental abilities.
On a second cognitive performance test, patients who received Gammagard declined by about 9.15 fewer points than placebo patients.
MRI analyses also showed patients treated with Gammagard saw a 6.7 percent decrease in annual ventricular enlargement in their brains, compared to a 12.3 percent rate in patients on a placebo.

The data were presented at a meeting of the American Academy of Neurology in Toronto.

Baxter might be able to file for FDA approval in 2012 if Phase 3 trials go well.

If you are interested in participating in the ongoing Phase 3 trial go here for more information -- Intravenous Immune Globulin (IVIg) -- Phase 3 Clinical Trial.


Baxter and New York-Presbyterian/Weill Cornell Announce 18-Month Data from Phase II Study of GAMMAGARD in Patients with Alzheimer's Disease

Baxter International Inc. (NYSE: BAX) and New York-Presbyterian Hospital/Weill Cornell Medical Center today announced results of an 18-month Phase II clinical study of GAMMAGARD LIQUID and GAMMAGARD S/D [Immune Globulin Intravenous (Human)] (marketed as KIOVIG outside of the U.S.) for mild-to-moderate Alzheimers disease. This marked the first announcement of clinical trial results measuring function and cognition in patients who received uninterrupted GAMMAGARD for a period of 18 months.

The study measured function using the Alzheimers Disease Cooperative Study-Clinical Global Impression of Change rating (ADCS-CGIC) and measured cognition using the Alzheimers Disease Assessment Scale-Cognitive Subscale score (ADAS-Cog). After 18 months, patients (n=14) who received GAMMAGARD continuously averaged approximately 1.36 points higher than patients (n=7) who initially received placebo (-0.64 vs. -2.0, p=0.011) on the ADCS-CGIC. Patients (n=14) who received GAMMAGARD continuously declined by approximately 9.15 fewer ADAS-Cog points than patients (n=6) who initially received placebo (approximately 6 point decline vs. 15 point decline, p=0.013).

Here is product info from a 2005 approval for Gammagard for imunodeficiencies.Its pretty safe but you will notice there are some renal damage warnings for older patients. It is made from human blood and can contain infectious agents.
http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm089392.htm

Supply has been a problem in the past, but I have no idea how they will handle supply to all Alzheimers patients. This article cites off label use. Could some of that be for Alzheimers already.
http://www.secscg.nhs.uk/home/specialised-services/ivig-immunoglobulin/

There have been problems with manufacture of immunoglobulin producte even at current levels.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm223968.htm

Another interesting point from an investors point of view is that there are several manufacturers of immunoglobulins already. How will that work?
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm105922.htm

Not a medical professional so all above could be wrong or misinterpreted so please do your own research.