Re: Info on Pfizer Exubera (FUSE) Presentation in Barcelona
in response to
by
posted on
Sep 04, 2012 11:48AM
Edit this title from the Fast Facts Section
OPC,
If you are misreading it ,so am I.When this is released it will be used by the shorts.We should remember however....
"Even if there was a real signal of lung cancer risk in Exubera (which there was not, by any means), that is no reason to jump to the conclusion that there is an across-the-board problem with inhaled insulin. I would point out that Exubera has been found to irritate the lungs of those who took it causing coughing, and worse, a decrease in lung function (i.e. the ability to breathe). Mannkind’s Technosphere Insulin does not have those problems. You can’t just lump all inhaled insulin into one basket. You have to look at the scientific data carefully and judge each product based on its merits, and you can bet that the FDA and its scientific advisers are sophisticated enough to do that.
Mannkind has stated categorically that they have not found any more lung cancer in Technosphere Insulin-using patients than that in the general population. In their May 5th conference call, Mannkind said that up till then they have had 4,849 patients in 25 completed and 7 ongoing trials, 2,684 which used Technosphere Insulin and 2,165 which were controls. In patient-years, they have so far had 2,182 patient-years using Technosphere Insulin and 1,708 patient-years using controls. In all that, they have found 1 case of lung cancer, plus 1 case of lung involvement in metastatic colorectal cancer. A metastatic cancer is one in which the tumor has spread from its primary site in the body to another site. This patient was found to have colorectal cancer which then spread to the lung, and clearly does not reflect at all on the lung cancer risk with Technosphere Insulin. One case (who was a former smoker, by the way) out of 2,182 patient-years comes out to a cancer rate of .046%, lower than that normally found in the general population.
In addition, Technosphere Insulin has gone through carcinogenicity studies (unlike Exubera, which did not). These involved a 2-year study in rats which inhaled either Technosphere Insulin or the Technosphere particles alone for 2 years. Standard carcinogenic studies generally involve 2 species. For the second species, Mannkind did a 6-month study in transgenic mice (mice genetically engineered so as to be more susceptible to cancer), in which they were injected with Technosphere Insulin or Technosphere particles alone. In both studies, no carcinogenic effect at all was found. "
http://seekingalpha.com/article/80843-mannkind-overlooked-biotech-with-excellent-prospects-part-ii