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Aegera is committed to conducting rigorous clinical trials that demonstrate the safety and efficacy of our product candidates. We design our trials to provide us with robust and relevant data to understand how our products can have the most meaningful impact in the appropriate patients.

If you are a patient or clinician and would like further information regarding any Aegera clinical trial, you can find more information on the Clinical Trials website:

http://clinicaltrials.gov/ct2/results?term=AEG35156

or please contact the respective trial sites

Product: AEG35156
Phase: I / II
Protocol Number: AEG35156-204
Area of Investigation: Relapsed or Refractory Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Follicular Lymphoma
Status: Starting in April 2008
Trial Site(s):
Hôpital Princess Margaret, Toronto, Canada

Summary:
This single agent, rising dose, Phase I trial is designed to determine the tolerability and safety of AEG35156 administered by daily 2-hour infusions for 3 days followed by once weekly 2-hour infusions in order to select an effective therapeutic dose range for Phase II trials.

Product: AEG35156
Phase: I / II
Protocol Number: AEG35156-203
Area of Investigation: Advanced non small cell lung cancer
Status: Ongoing
Trial Site(s):
Rocky Mountain Cancer Centers, Denver, CO; Central Indiana Cancer Centers, Indianapolis, IN; Virginia Oncology Associates, Norfolk VA; Cancer Centers of the Carolina, Greenville, SC; Dayton Oncology & Hematology, PA, Kettering, OH; Northwest Cancer Specialists – Vancouver, WA.

Summary:
This Phase I/II trial is an open-label study of AEG35156 administered by daily 2-hour infusions for 3 days prior to chemotherapy with carboplatin and paclitaxel followed by once weekly 2-hour infusions of AEG35156 in patients with advanced NSCL cancer. The trial is designed to find an effective and safe dose to treat NSCL cancer patients and to determine the response rate in this patient population.

Product: AEG35156
Phase: I / II
Protocol Number: AEG35156-201
Area of Investigation: Advanced Pancreatic Cancer
Status: Ongoing
Trial Site(s):
Scottsdale Healthcare, Scottsdale, AZ; Mayo Clinic, Scottsdale AZ.; University of Arizona, Tucson, AZ

Summary:
This Phase I/II trial is an open-label study of AEG35156 administered by daily 2-hour infusions for 3 days prior to chemotherapy with gemcitabine followed by once weekly 2-hour infusions of AEG35156 in patients with advanced pancreas cancer. The trial is designed to find an effective and safe dose to treat pancreas cancer patients and to determine the response rate in this patient population. This trial will also provide Aegera with information regarding the pharmacokinetic properties of AEG35156 for future Phase II / III clinical trials.

Product: AEG35156
Phase: I
Protocol Number: AEG35156-104
Area of Investigation: Advanced cancers
Status: Ongoing
Trial Site(s):
Christie Hospital, Manchester, UK

Summary:
This single agent, rising dose, Phase I trial is designed to determine the tolerability, safety and pharmacodynamic and pharmacokinetic properties of AEG35156 administered by daily 2-hour infusions for 3 days followed by once weekly 2-hour infusions in order to select an effective therapeutic dose range for Phase II trials.

Product: AEG35156
Phase: I / II
Protocol Number: AEG35156-103
Area of Investigation: Refractory or relapsed acute myeloid leukemia (AML)
Status: Ongoing
Trial Site(s):
The University of Texas M. D. Anderson Cancer Center, Houston, Texas, Johns Hopkins Hospital, Baltimore, Northwestern University Hospital, Chicago, UCLA Medical Center, Los Angeles and Princess Margaret Hospital - University Health Network, Toronto, Hopital Maisonneuve Rosemont, Montreal, Canada.

Summary:
This Phase I/II trial is an open-label study of AEG35156 administered by daily 2-hour infusions for 3 days prior to chemotherapy with ara-C and idarubicin followed by once weekly 2-hour infusions of AEG35156 in patients with refractory or relapsed AML. The trial is designed to find an effective and safe dose to treat leukemia patients and to determine the response rate in this patient population. This trial will also provide Aegera with information regarding the pharmacokinetic and pharmacodynamic properties of AEG35156 for future Phase II / III clinical trials.

Product: AEG35156
Phase: I
Protocol Number: AEG35156-102B
Area of Investigation: Solid tumor patients for whom docetaxel therapy is indicated
Status: Enrolment closed
Trial Site(s):
Jewish General Hospital, Montreal, Canada; Princess Margaret Hospital/University Health Network, Toronto, Canada; BC Cancer Agency, Vancouver, Canada.

Summary:
The trial is studying AEG35156 administered by daily 2-hour infusions for 3 days prior to docetaxel (Taxotere®) treatment followed by once weekly 2-hour infusions of AEG35156 and every 3-week administration of docetaxel in patients with solid tumors for whom docetaxel therapy is indicated. The main objective of this study is to determine the recommended Phase II dose of AEG35156 to be administered in combination with docetaxel for future clinical research studies. This multicenter trial is being coordinated by the National Cancer Institute of Canada Clinical Trials Group at Queen’s University, a research group supported by funding from the Canadian Cancer Society.

Product: AEG35156
Phase: I
Protocol Number: AEG35156-101
Area of Investigation: Advanced tumors
Status: Closed
Trial Site(s):
Christie Hospital, Manchester, UK; University of Edinburgh Cancer Research Centre, UK.

Summary:
This single agent, rising dose, Phase I trial is designed to determine the tolerability, safety and pharmacodynamic and pharmacokinetic properties of AEG35156 administered by continuous intravenous infusions in order to select an effective therapeutic dose range for Phase II trials. The trial is conducted under the auspices of Cancer-Research UK.

 
 

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