MONTREAL, CANADA and GLENEDEN BEACH, OREGON--(Marketwire - March 19, 2009) - AngioChem, a biotechnology company discovering and developing drugs that are uniquely capable of crossing the blood-brain barrier, today announced the presentation of preliminary safety and tolerability 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 a favorable safety and tolerability profile, as evidenced by laboratory and neurocognitive data, and does not show evidence of eliciting an immune response. Additionally, the company presented preclinical data demonstrating the compound’s unique ability to cross the blood-brain barrier to effectively deliver potent therapeutic doses. These data were presented in poster sessions at the Fifteenth Annual Blood-Brain Barrier Consortium Meeting in Oregon, being held March 19 to 21, 2009.
ANG1005 is a novel taxane derivative with the structure of an engineered peptide compound (EPiC) that is designed to cross the blood-brain barrier (BBB) by receptor-mediated transcytosis, overcoming the BBB’s normal function of blocking foreign substances which prevents more than 95 percent of all drugs from reaching the brain.
“We are highly encouraged by these findings - particularly the preliminary clinical efficacy data which has shown encouraging tumor responses - which illustrate the unique ability of ANG1005 to successfully cross the BBB to treat brain cancers,” said Jean-Paul Castaigne, M.D., President and Chief Executive Officer of AngioChem. “We look forward to presenting additional efficacy data from the Phase 1/2 studies of ANG1005 at a medical meeting in April, as well as advancements with product programs in our pipeline for other brain diseases and disorders.”
Key findings from the clinical and preclinical studies presented at the Fifteenth Annual Blood-Brain Barrier Consortium Meeting include:
- ANG1005 showed a favorable safety and tolerability profile based on data for all 63 study patients dosed to date in the Phase1/2 studies;
- Adverse events were manageable and less severe than those engendered by paclitaxel in comparable dosages and included neutropenia and leucopenia;
- Data available from 31 study patients in the Phase1/2 studies indicated that ANG1005 does not elicit an immune response, as measured by Enzyme-Linked ImmunoSorbent Assays (ELISA);
- Neurocognitive data available for 18 patients in the Phase1/2 studies showed that ANG1005 does not show evidence of central nervous system toxicity;
- ANG1005 successfully and rapidly crossed the BBB into the brain tissues at a rate 100 times greater than paclitaxel and distributed homogeneously across all the brain regions; and,
- ANG1005 caused a regression of tumor size in rats as opposed to a progression in two control groups.
About ANG1005
ANG1005 is a novel taxane engineered peptide compound (EPiC) 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.
ANG1005 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. For recurrent malignant gliomas and metastatic brain cancer, treatment options for patients are limited and prognoses are dismal.
Phase 1/2 studies of ANG1005 in patients with primary and secondary brain cancers demonstrated that ANG1005 has an excellent safety and tolerability profile, as evidenced by laboratory and neurocognitive data, and does not show evidence of eliciting an immune response in humans.
About AngioChem
AngioChem is a clinical-stage biotechnology 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, psychiatric disorders, 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.
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