Aegera Therapeutics Initiates Four Phase I/II Clinical Trials for AEG35156



    MONTREAL, Oct. 2 /CNW Telbec/ - Aegera Therapeutics announced today the
initiation of four new clinical oncology studies for AEG35156, a second
generation anti-sense therapeutic targeting the X-Linked Inhibitor of
Apoptosis (XIAP), a key member of the Inhibitor of Apoptosis protein (IAP)
family.
    Following completion of several Phase I trials, Aegera has initiated an
open-label Phase II study in acute myeloid leukemia (AML) with AEG35156 given
in combination with ara-C and idarubicin. This study is being performed at six
sites across North America including MD Anderson (Texas), Princess Margaret
Hospital (Ontario), Johns Hopkins Medical Center (Maryland), Northwestern
Memorial Hospital (Illinois), University of California in Los Angeles
(California) and Maisonneuve-Rosemont Hospital (Quebec).
    In addition, three other multicenter open-label Phase I/II studies have
been initiated with AEG35156 in pancreatic cancer, advanced breast cancer and
advanced non-small cell lung cancer. In these studies, AEG35156 will be
combined with current standard of care chemotherapeutics. The Phase I arm of
these trials will determine the recommended dose of AEG35156 to be used in
combination with the respective chemotherapeutic agents. The Phase II arm of
each study will evaluate the effects of combining AEG35156 with chemotherapy
on the expected response rate in these patient populations.
    "The mechanism of action of AEG35156 strongly suggests that it will be
effective in combination with chemotherapeutics across a wide spectrum of
cancer types," commented Aegera's Chief Executive Officer, Dr. Michael
Berendt, "Our initial Phase II studies in AML, pancreatic, breast, and
non-small cell lung cancer were chosen based on the preclinical data, our
understanding of the relevance of the XIAP target, clinical correlates and the
considerable medical need for improved treatment in these cancer types."
    "Early clinical evidence indicates that AEG35156 reduces XIAP mRNA and
protein levels in some solid tumors and hematologic cancers," stated Dr. Bruce
Chabner, Aegera Clinical Advisory Board member. "The biological activity of
AEG35156, if it is borne out in these trials, should make cancer cells more
susceptible to standard chemotherapeutics."

    About AEG35156

    Cancer cells acquire multiple mutations that disable their normal
response to apoptotic triggers. AEG35156, a second generation anti-sense which
targets XIAP, is designed to lower the apoptotic threshold of cancer cells,
enhancing their sensitivity to intrinsic death and chemotherapy, without
harming healthy cells. Aegera's published data with AEG35156, both in vitro
and in vivo, strongly supports this hypothesis, and validates XIAP as a novel
drug target for the development of anti-cancer therapeutics. AEG35156 has
demonstrated strong efficacy in models of lung, breast, ovarian, colorectal
and prostate cancers.

    About Aegera Therapeutics Inc.

    Aegera Therapeutics is a clinical stage biotechnology company focused on
developing drugs that control apoptosis to address major unmet medical needs.
Multiple programs are in development to induce apoptosis to kill cancer cells
and to prevent apoptosis to save injured neuronal cells:

    
    - AEG35156 targets the key anti-apoptotic protein XIAP, and is currently
      in multiple human clinical trials for the treatment of solid tumors and
      leukemia;
    - LS104 is a novel, non-ATP competitive, small molecule tyrosine kinase
      inhibitor targeting therapeutically significant kinases including JAK2
      and Bcr-Abl;
    - AEG40826 is a potent small molecule that neutralizes the activity of
      key Inhibitor of Apoptosis Proteins (IAPs), and has begun definitive
      IND-enabling preclinical toxicology studies as an anti-cancer
      therapeutic;
    - AEG33773 is a novel, orally bioavailable small molecule developed to
      treat painful diabetic neuropathy; definitive IND-enabling preclinical
      toxicology testing has been initiated.
    

    Website: www.aegera.com




For further information:

For further information: Donald Olds, MSc, MBA, Chief Operating Officer
& CFO, Aegera Therapeutics Inc., (514) 288-5532 *295, donald.olds@aegera.com

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AEGERA THERAPEUTICS INC.

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