Replies to post #9604 on GTC Biotherapeutics (fka GTCB)

[genisi]

These are not the final results. Those will be available on Aug. BLA will be submitted by year end, FDA approval another 7-10 months. Time to market mid-end 09. The stock is up 13% as I type.

[oldberkeley]

Dew or Genisi:

I more-or-less :-) understand that GTC has a recombinant product as opposed to Kamada's plasma-derived AAT.

Is the posting of their news simply a prudent and valuable continuation of the "keeping track of the competition" strategy, or are you posting it because it might have immediate relevance to GTC's stock price or ongoing partnership discussions? If the latter, could you elaborate? TIA.

[biopearl]

Dew, I find this a very interesting post. Can you estimate how many units of collected human plasma would be required for a therapeutic dose? I assume out goat A1AT is a "biosimilar" not a bioequivalent. None the less one would think Kamada would be very interested in GTCBs technology as a way to provide pure, high quality product that did not require human plasma to produce. The common contact with the Alpha 1 Foundation is interesting and one would think they in particular would try to find a way to build a bridge between the two companies, to support GTCBs ongoing efforts. (Of course I thought the same thing about Bill Gates and Gtcb's dormant/read dead, malaria vaccine...) If the goat A1AT were a bioequivalent wouldn't that be a good thing (the planned half life issues I suppose would make that impossible)? My already shrunken 'nads are now the size of raisens but I would still buy more if I could. Regards to all, bp

[keitern]

"Oddly, this PR does not say that a BLA will be submitted forthwith for the hereditary deficiency indication"

http://investorshub.advfn.com/boards/read_msg.asp?message_id=28121695

Perhaps, in light of the recent trouble with inhaled insulin, this program will be shelved as well.

[genisi]

Alpha1-Antitrypsin Deficiency Carriers, Tobacco Smoke, Chronic Obstructive Pulmonary Disease, and Lung Cancer Risk

Ping Yang, MD, PhD; Zhifu Sun, MD; Michael J. Krowka, MD; Marie-Christine Aubry, MD; William R. Bamlet, MS; Jason A. Wampfler, BS; Stephen N. Thibodeau, PhD; Jerry A. Katzmann, PhD; Mark S. Allen, MD; David E. Midthun, MD; Randolph S. Marks, MD; Mariza de Andrade, PhD

http://archinte.ama-assn.org/cgi/content/short/168/10/1097

Arch Intern Med. 2008;168(10):1097-1103.

Background: Genetic susceptibility in lung cancer risk has long been recognized but remains ill defined, as does the role of tobacco smoke exposure and chronic obstructive pulmonary disease (COPD).

Methods: Using a dual case-control design, we tested whether alpha1-antitrypsin deficiency ({alpha}1ATD) carriers are predisposed to a higher risk of lung cancer, adjusting for the effects of tobacco smoke exposure and COPD. A total of 1856 patients with incident lung cancer were included in the study; 1585 community residents served as controls. A second control group was composed of 902 full siblings of the patients. We first modeled 1585 case-control pairs without the {alpha}1ATD variable using multiple logistic regression analysis and then modeled the {alpha}1ATD allele type in the presence of other known risk factors of lung cancer.

Results: We found a significantly increased lung cancer risk among {alpha}1ATD carriers from 2 parallel case-control comparisons: when patients were compared with unrelated controls, {alpha}1ATD carriers had a 70% higher risk of developing lung cancer than noncarriers (odds ratio, 1.7; 95% confidence interval, 1.2-2.4). In a further comparison of patients with their cancer-free siblings, we found a 2-fold increased lung cancer risk in {alpha}1ATD carriers (95% confidence interval, 1.4-2.7). Stratified analysis by tumor histologic subtypes showed a significant increase for adenocarcinoma and squamous cell carcinoma among {alpha}1ATD carriers.

Conclusion: Our results suggest that {alpha}1ATD carriers are at a 70% to 100% increased risk of lung cancer and may account for 11% to 12% of the patients with lung cancer in our study.