AGENNIX AG

EANS-News: AGENNIX AG /

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Research & Development

@@start.t2@@Heidelberg (euro adhoc) - Agennix AG Provides Update on
                                         Development of Talactoferrin

Planegg/Munich (Germany), Princeton, NJ  and  Houston,  TX,  August  5,  2010  -@@end@@

Agennix AG (Frankfurt Stock Exchange: AGX)  today  provided  an   update  on  its development status and plans for oral talactoferrin.

Enrollment on track in Phase III FORTIS-M trial in non-small cell lung cancer The Company reported that, as of July 31, 2010, 45% of   patients  (327)  in  the FORTIS-M trial had been enrolled.  The total planned enrollment in the study  is 720 patients. FORTIS-M is evaluating talactoferrin  plus  best  supportive  care compared to placebo plus best supportive care in patients  with  non-small  cell lung cancer, whose disease has progressed following two or more prior treatment regimens.  The trial remains on track with enrollment expected  to  complete  in the first half of 2011 and topline data expected by the end of 2011, should  all proceed as anticipated.

Phase III registration plan in severe sepsis The Company also reported that it has held an End-of-Phase II meeting  with  the U.S. Food & Drug Administration (FDA) to discuss future  development   plans  for talactoferrin in severe  sepsis.    The  Company  plans  to meet  with  European regulatory authorities within the next few months  to  discuss  its  development plans in this indication. In its discussions with the Company, the FDA  strongly recommended that Agennix conduct two  adequate  and  well-controlled  Phase  III studies to support a potential Biologic License Application (BLA) submission.

Agennix plans to start an initial randomized,  double-blind,   placebo-controlled Phase III trial evaluating oral talactoferrin  in adult  patients  with  severe sepsis (sepsis plus one or more organ dysfunctions) in early 2011. In  order  to maximize the chances of success, the Company intends to base the design of  this initial Phase III  trial  closely  on  the  randomized,  double-blind,   placebo- controlled Phase II trial, the  topline  results  of  which were  announced  in December  2009.  In  the  Phase  III  trial,  the Company    plans    to    accrue approximately 930 adult patients with severe sepsis  at  100-150  leading  sites worldwide for the treatment of sepsis.  Similar  to  the  Phase  II  trial,  all potentially eligible  patients  for  the  Phase  III  trial  will  be centrally screened  prior  to  enrollment  to  confirm  that  they   meet  the  eligibility criteria.    Patients  will  be  randomized  to receive  oral  talactoferrin  or placebo.  Patients in both arms will also receive  standard  of  care  treatment for severe sepsis  in  an intensive  care  unit  (ICU)  setting.    The  primary endpoint of the Phase  III  trial  will  be  28-day  all-cause  mortality,  with secondary endpoints to include longer-term survival. The FDA has confirmed  that the proposed  primary  endpoint  is  acceptable  and indicated  that  secondary endpoints should include assessment of mortality at 3, 6 and 12 months.

Rajesh Malik, M.D., Chief Medical Officer of Agennix, said, "We are   excited  to advance the development of talactoferrin in severe   sepsis.    This  is  a  life- threatening condition that, with an estimated mortality rate of 30%  or  higher, is urgently in need of new, effective therapies.  We look forward to  initiating a Phase III trial in early 2011 in this important indication."

Data update from Phase II trial in severe sepsis The Company also reported that, as part of an independent  final  audit  of  the Phase II trial with talactoferrin  in  severe  sepsis  prior  to  preparing for publication of the results, it was determined that one   additional  patient  was affected by the previously disclosed drug labeling and randomization error.  The identified patient had mistakenly been included in the placebo  arm  and  should have been included in the talactoferrin arm.  Thus, there were  97  patients   in the talactoferrin arm and 93 patients in the placebo  arm   (previously  reported as 96 patients in the talactoferrin arm  and   94  in  the  placebo  arm).    This change did not have a material effect on the outcome  of  the  trial.    Baseline characteristics of patients entering the study were mostly balanced between  the talactoferrin and placebo groups.

The final primary endpoint results are now as follows:  46%  relative reduction (13% absolute reduction)  in  28-day  all-cause  mortality from  26.9%  in  the placebo arm to 14.4% in the talactoferrin arm (two-tailed p-value  adjusted  for cardiovascular dysfunction = 0.05, odds ratio by logistic regression analysis  = 0.48). These results reflect a slightly larger improvement in mortality  in  the talactoferrin arm when compared to the placebo arm than earlier reported.[1] Talactoferrin continued to appear to show an effect over the  longer  term,  at three and six months. These results reflect a slightly  larger  improvement  in three- and six-month mortality in the talactoferrin arm  when  compared  to  the placebo arm than earlier reported.  Three-month all-cause  mortality  was  29.7% in the placebo arm compared to 17.9%  in  the  talactoferrin  arm,  an   absolute reduction of 12% and relative reduction of 40% (adjusted   two-tailed  p-value  = 0.08,  odds  ratio  =  0.54).[2]  At  six   months,  there  was  a  statistically significant reduction in all-cause mortality from 35.6% in the  placebo  arm  to 21.1% in the talactoferrin arm,  an  absolute  reduction  of  15%  and  relative reduction of 41% (adjusted two-tailed p-value = 0.04, odds ratio = 0.50).[3]

Talactoferrin continued to appear to show a substantial trend toward a  decrease in 28-day all-cause mortality in the upper two  baseline APACHE  II  score  (an assessment of the severity of the condition) quartiles, with a  slight  decrease in the second quartile and a slight increase in patients in  the  lowest  APACHE II quartile (scores 0-19), i.e., the least sick patients. It  should  be  noted, however, that, for each of the lower two quartiles, the difference was only  one death between the arms. None of the differences was   statistically  significant. In addition, there appears to have been no effect on mortality in women in  this trial, although it is unclear whether this outcome would be  seen  in  a  larger Phase III trial or whether it is merely a consequence of  the  relatively   small number of patients in this trial.

The above analyses were conducted on  a  modified  intent-to-treat   basis  (also referred  to  as  intent-to-treat  as  treated),   meaning  that  patients    were evaluated based on  the  treatment   they  actually  received  (talactoferrin  or placebo) during their first week of treatment.

Talactoferrin was shown  to  be  very  well  tolerated  in  the   study  with  no significant differences in adverse events between the two  treatment  arms.  Of those adverse events considered to be possibly related to  treatment,  the  most frequently reported category  in  both  treatment  groups  was  gastrointestinal disorders (5.5% of patients in the talactoferrin arm and  5.4%  in   the  placebo

@@start.t3@@arm).  There were  no  serious  adverse  events  considered  to  be  related  to treatment with talactoferrin.

The Company expects the final  results  from  the  trial  to  be  submitted  for publication in a peer-reviewed journal.

About talactoferrin Talactoferrin  is  an  oral    biologic    therapy    with    immunomodulatory    and@@end@@

antibacterial properties, which is being studied for  the  treatment
of  cancer and severe  sepsis.  Talactoferrin  has  demonstrated  
activity  in  randomized, double-blind, placebo-controlled Phase II
studies in non-small cell lung  cancer (NSCLC), as well as in severe
sepsis. As a result of the promising results  from Phase II studies,
two Phase III trials with talactoferrin  in  NSCLC  have  been
initiated.  NSCLC is one of the most common types of cancer  
worldwide  and  the most  frequent  cause  of  cancer  death.      
Agennix  also  plans    to    develop talactoferrin further for the
treatment of  severe  sepsis.    Talactoferrin  has been shown to be
very well tolerated in these patient populations.

About Agennix Agennix AG is a publicly listed biopharmaceutical company  that  is  focused  on the development of novel therapies that  have  the  potential  to  substantially improve the length and quality of life of critically ill patients  in  areas  of major unmet medical need. The Company´s most advanced program is  talactoferrin, an oral therapy that has  demonstrated  activity  in  randomized,   double-blind, placebo-controlled Phase II studies in non-small cell lung cancer,  as  well  as in severe sepsis. Talactoferrin is currently in Phase  III  clinical  trials  in non-small cell lung cancer, and Agennix plans to develop  this  program  further for the treatment of severe sepsis. Other clinical development programs   include RGB-286638, a multi-targeted kinase inhibitor  in  Phase  1   testing;  the  oral platinum-based compound satraplatin; and a topical  gel  form  of  talactoferrin for diabetic foot ulcers. Agennix´s registered seat is in  Heidelberg,  Germany. The Company has three sites of operation:  Planegg/Munich,  Germany;  Princeton, New Jersey and Houston, Texas. For  additional  information,  please visit  the Agennix Web site at www.agennix.com.

This press  release  contains  forward-looking  statements,  which   express  the current  beliefs  and  expectations  of  the  management of  Agennix  AG.  Such statements are based on current  expectations and  are  subject  to  risks  and uncertainties, many of which are beyond our control,  that  could  cause  future results, performance or achievements to differ significantly from  the  results, performance  or  achievements  expressed  or  implied  by  such   forward-looking statements. There can be no guarantee that the Company will  move  talactoferrin forward in development for severe sepsis in a timely manner, if at all, or  that talactoferrin will ultimately be  approved  for  sale  in  any  country.  Actual results could differ materially  depending  on  a  number  of  factors,  and we caution investors not to place undue reliance on the forward-looking  statements contained in this press release. Forward-looking statements  speak  only  as  of the date on which they are made and Agennix undertakes no obligation  to  update these forward-looking statements, even if new information becomes   available  in the future.

----------------------- [1] Previously, the reported 28-day all-cause mortality results were as follows: 26.6% in the placebo group compared to 14.6% in the talactoferrin group, a 12% absolute and 45% relative reduction (two-tailed adjusted p-value = 0.06, odds ratio = 0.49).

[2] Previously, the reported three-month all-cause mortality was 29.3% in the placebo arm compared to 18.1% in the talactoferrin arm (adjusted two-tailed p- value = 0.09, odds ratio = 0.55).

[3] Previously, the reported six-month all-cause mortality was 35.2% in the placebo arm versus 21.3% in the talactoferrin arm (adjusted two-tailed p-value = 0.05, odds ratio = 0.51).

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ots Originaltext: AGENNIX AG
Im Internet recherchierbar: http://www.presseportal.ch

Further inquiry note:
Agennix AG
Investor Relations & Corporate Communications
Phone: +49 (0)89 8565 2693
ir@agennix.com

In the U.S.: Laurie Doyle
Director, Investor Relations & Corporate Communications
Phone: +1 609 524 5884
laurie.doyle@agennix.com

Additional media contact for Europe:
MC Services AG
Raimund Gabriel
Phone: +49 (0) 89 210 228 0
raimund.gabriel@mc-services.eu

Additional investor contact for Europe:
Trout International LLC
Lauren Williams, Vice President
Phone: +44 207 936 9325
lwilliams@troutgroup.com

Branche: Pharmaceuticals
ISIN:      DE000A1A6XX4
WKN:        A1A6XX
Index:    CDAX, Prime All Share, Technology All Share
Börsen:  Frankfurt / regulated dealing/prime standard
              Berlin / free trade
              Hamburg / free trade
              Düsseldorf / free trade
              Hannover / free trade
              München / free trade



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