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Post by babaoriley on Dec 13, 2013 1:40:46 GMT -5
I was discussing MNKD with a guy who is a doctor. He told me that he remembers a while back - he figures it must have been when Exubera was coming out - concerns about lung toxicity / side effects from repeatedly putting insulin, presumably with other junk, down there. I told him that I believe there has been no problem with lung toxicity for Afrezza, but could not point him at anything in particular. Can any of you help me on that issue? Thanks.
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Post by Chris on Dec 13, 2013 4:16:40 GMT -5
I was discussing MNKD with a guy who is a doctor. He told me that he remembers a while back - he figures it must have been when Exubera was coming out - concerns about lung toxicity / side effects from repeatedly putting insulin, presumably with other junk, down there. I told him that I believe there has been no problem with lung toxicity for Afrezza, but could not point him at anything in particular. Can any of you help me on that issue? Thanks. "The pharmacokinetic profile of Afresa sets it apart from all other insulin products. The large surface area of the lung provides unique access to the circulatory system. The pH-sensitive Afresa particles immediately dissolve upon contact with the lung surface, releasing insulin monomers that rapidly enter the bloodstream." www.drugs.com/clinical_trials/mannkind-reports-positive-results-final-two-pivotal-phase-3-clinical-studies-type-1-type-2-diabetes-6365.html"“We are encouraged by this long-term study which demonstrates that over four years, AFRESA maintained glycemic control with changes in lung function comparable to that seen in diabetic patients treated with injectable and oral therapies,” said Peter Richardson, Corporate Vice President and Chief Scientific Officer, MannKind Corporation. “These findings add to the growing body of clinical evidence that AFRESA is a promising therapeutic option for this patient population.” www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1337942&highlight= |
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Post by babaoriley on Dec 13, 2013 10:44:32 GMT -5
Muchas gracias, Chris!
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Post by Chris on Dec 13, 2013 14:34:52 GMT -5
No problemo mi amigo, Baba! |
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Post by afrezzamiracle on Dec 16, 2013 22:27:20 GMT -5
"It seems to me that the concern about lung cancer should have ended by now since there is no factual basis for such concern. Even for Exubera, there was no conclusion as to causality or acceleration and AFRESA is so very, very different. In relation with AFRESA, it is certainly less risky than for some other chronically entailed drugs and even less so than breathing in a large city. An advisory committee has dismissed any risk of lung cancer from AFRESA. While we are seriously concerned about this risk, all of the data gives us confidence that any concern about lung cancer with AFRESA is without foundation and is bogus. Nevertheless, we must address some perceptions that have been created."
-Alfred Mann
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MannKind has also undertaken a more comprehensive examination of the toxicology profile of Technosphere(R) Insulin than has been reported for any other inhaled insulin. Last year, MannKind completed a two-year carcinogenicity study in rats in which Technosphere(R) Insulin, and large doses of Technosphere(R) particles alone, were well tolerated after daily inhalations for 104 consecutive weeks. There were no indications in these studies that either Technosphere(R) Insulin or Technosphere(R) particles alone had any carcinogenic potential or caused any cellular proliferation in the lungs. MannKind also recently completed a six-month carcinogenicity study in transgenic mice, finding no macroscopic indications of carcinogenicity in animals given daily subcutaneous injections of Technosphere(R) Insulin or Technosphere(R) particles for 26 consecutive weeks. In addition, MannKind plans to submit data from over 100 preclinical studies supporting the safety of our product, the vast majority of which have already been completed.
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"We also did high-definition CT scans on the 600 patients in our study. That’s the best you can do with people. We saw no change in their lungs, and some of them have been using the product for up to 5 years now."
-Al Mann
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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.
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Post by babaoriley on Dec 16, 2013 23:01:08 GMT -5
Good stuff, miracle, I've passed it on already!
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