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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 74 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 to effectively 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 created from the EPiC platform, 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 solid tumor 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/m2, five patients experienced an objective response, including one partial response, two minor responses and two had their disease stabilize;
- In the 22 malignant glioma patients who received ANG1005 at six sub-therapeutic dose levels evaluated to date, seven patients experienced an objective response at this preliminary analysis, while dose escalation
- 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, who achieved a minor response, showed significant improvement in memory, processing speed and executive function after six, 12 and 24 weeks of therapy.
- Tumor sample data collected from a patient after receipt of a single 200mg/m2 dose of ANG1005 show that the tumor parenchymal concentration of ANG1005 was approximately 20 times greater than that reported for paclitaxel. This value is expected to be significantly higher at MTD.Preliminary data from a second patient’s tumor sample confirms this trend with an estimated ANG1005 concentration in the tumor relative to blood exceeding 25%.
About ANG1005 // ANG1005 is a novel taxane derivative, created from AngioChem’s proprietary Engineered Peptide Compound (EPiC) platform, that is designed to cross the BBB. Studies have shown that ANG1005 gains entry into the brain compartment by targeting the low-density lipoprotein receptor-related protein (LRP), which is one of the most highly expressed receptors on the surface of the BBB. Once inside the brain, ANG1005 enters tumor cells using the same receptor-mediated pathway through LRP, which is upregulated in various cancer cells including malignant glioma and metastatic cancers in the brain.
About AngioChem //AngioChem 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 to address significant medical needs, many of which cannot be effectively addressed due to the fundamental physiological challenge the blood-brain barrier presents for therapeutic 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 diseases and 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.