AngioChem Presents New Positive Clinical Data on ANG1005 for Brain Cancers at AACR
- Data Demonstrate Encouraging Tumor Responses -
- Proprietary compounds cross the blood-brain-barrier through novel receptor-based approach -
MONTREAL, CANADA and Denver, CO, April 21, 2009 – AngioChem, a biotechnology company discovering and developing drugs that are uniquely capable of crossing the blood-brain barrier, today presented promising new safety, tolerability and preliminary efficacy data for its lead drug candidate, ANG1005, from two separate Phase 1/2 studies in patients with recurrent malignant glioma and in patients with advanced solid tumors and brain metastases. The data demonstrated that ANG1005 has potential efficacy as evidenced by tumor regression and the halting of tumor progression; has a favorable safety and tolerability profile; and has the ability to cross the blood-brain barrier toeffectively deliver active therapeutic concentrations. These data were presented at the annual meeting of the American Association for Cancer Research (AACR), being held in Denver, Colorado, from April 18-22, 2009.
Primary (glioma) and secondary (metastases from other solid tumors) brain cancers are highly aggressive and fatal cancers that affect approximately 200,000 patients annually in the United States. Treatment options for brain cancer patients are limited and prognoses are dismal due to the effective role the blood-brain barrier (BBB) serves as the natural guardian of the brain, preventing more than 95 percent of drugs from reaching the brain. AngioChem, leveraging its proprietary Engineered Peptide Compound (EPiC) platform, is developing ANG1005 as its first clinical compound within a deep and broad pipeline of product candidates uniquely capable of crossing the BBB to treat a wide range of brain diseases.
“We are very excited by the encouraging tumor responses ANG1005 has produced in a trial that was designed primarily to assess safety and tolerability,” said Jean-Paul Castaigne, M.D., President and Chief Executive Officer of Angiochem. “While we recognize that this is a study on a relatively small population of patients, these encouraging tumor responses support our belief that ANG1005 has the unique ability to successfully cross the BBB and has the remarkable potential to treat brain cancers in a completely new way. We look forward to receiving the final data and, with the right partner, initiating a larger and possibly pivotal clinical trial early next year to further explore the potential of ANG1005.”
ANG1005, a novel taxane derivative, is currently being evaluated in two separate Phase 1/2 multicenter, open-label, dose escalation studies to explore the maximum tolerated dose and obtain data on safety, tolerability and preliminary evidence of efficacy in patients with recurrent malignant glioma and in patients with advanced solid tumors and brain metastases.
AngioChem presented preliminary data from these two studies based on available data from 32 patients in the malignant glioma study and 42 patients in the advanced solidtumor and brain metastases study. Enrollment in these studies continues. Key findings from the data from these patients, presented at AACR, include:
- Tumor response data, as measured by magnetic resonance imaging (MRI) or computerized tomography ( CT), show that ANG1005 has potential efficacy as evidenced by tumor regression and the halting of tumor progression;
- In the seven advanced solid tumor patients with brain metastases who received ANG1005 at a dose of >300mg/m^2 , five patients experienced a response, including one partial response, two minorresponses and two had their disease stabilize;
- In the 22 malignant glioma patients who received ANG1005 at sixsub-therapeutic dose levels evaluated to date, seven patients experienced a response at this preliminary analysis, while dose escalation continues;
- Safety and tolerability data show that adverse events from treatment with ANG1005 were manageable and less severe than those engendered by paclitaxel in comparable dosages and included neutropenia, leucopenia, thrombocytopenia and anemia;
- Immunogenicity data, as measured by Enzyme-Linked ImmunoSorbent Assays(ELISA), show that ANG1005 does not elicit an immune response, including in patients who have received up to six treatment cycles;
- Neurocognitive data show that ANG1005 does not show evidence of central nervous system toxicity;
- One patient with advanced solid tumors with brain metastases, whoachieved a minor response, showed significant improvement in memory, processing speed and executive function after six, 12 and 24 weeks oftherapy.
- Tumor sample data show that the active therapeutic concentration of ANG1005was approximately 20 times greater than that of paclitaxel, as measured in theparenchyma of a tumor sample that was collected from a patient after receipt of asingle 200mg/m 2 dose of ANG1005 and preliminary data from a second tumor sample and different patient confirms this trend.
About AngioChemAngioChem is a clinical-stage biotechnology company discovering and developing new breakthrough drugs that are uniquely capable of crossing the blood-brain barrier to treat brain diseases. These new Engineered Peptide Compounds (EPiC) have the potential toaddress significant medical needs, many of which cannot be effectively addressed due to the fundamental physiological challenge the blood-brain barrier presents fortherapeutic intervention. AngioChem’s lead product candidate, ANG1005, is in two separate Phase 1/2 clinical studies in patients with primary brain cancers and in cancer metastases. Additionally, AngioChem is developing a deep and broad product pipeline, including small and large molecules, for the treatment of a wide range of brain diseasesand related disorders, including brain cancer, cancer metastases, neurodegenerative and metabolic diseases. Founded in 2006, AngioChem maintains headquarters in Montreal, Canada. For additional information about the Company, please visit
http://www.angiochem.com.