Healthcare Industry News: paclitaxel
News Release - October 24, 2007
AngioChem Announces IND Clearance From the US FDA for its Lead Product, ANG1005, for the Treatment of Brain CancerMONTREAL, CANADA--(Healthcare Sales & Marketing Network)--Oct 24, 2007 -- AngioChem is pleased to announce that it has received clearance from the US Food and Drug Administration to move its lead drug candidate, ANG1005, into Phase 1/2 clinical development targeting primary (glioblastoma) and metastatic brain tumors. ANG1005 consists of a proprietary vector that transports drugs across the blood-brain barrier (BBB) conjugated to three molecules of paclitaxel - a well-known anti-cancer drug. AngioChem believes that its vector will allow paclitaxel to extend its treatment potential to forms of cancer that remain virtually untreatable to date.
AngioChem is ready to start two parallel phase 1/2 studies involving approximately 30 patients per study: one study treating recurrent glioblastoma, and a second study treating brain metastasis. The primary endpoint of both studies is safety, tolerability and determination of the maximum tolerated dose (MTD). Secondary endpoints include determination of the pharmacokinetic profile of ANG1005, a preliminary assessment of efficacy, as well as the measurement of ANG1005 levels in surgically removed tumors from glioblastoma patients. Both studies will be conducted at multiple sites in the United States.
"We anticipate that these studies with ANG1005 will confirm the positive efficacy and the excellent tolerability profile we observed in preclinical studies," said Dr. Jean-Paul Castaigne, Chief Executive Officer of AngioChem. "Moreover, we expect the data to support our efforts to validate our platform vector technology against untreatable brain cancers and other diseases of the central nervous system."
About ANG1005 and the AngioPep vector technology
The key challenge to treating brain diseases is the blood-brain barrier (BBB), which prevents more than 95% of drugs from penetrating the brain. AngioChem has developed a physiological way for drugs to reach the brain by engineering a family of peptides that acts as vectors. AngioChem believes that its AngioPep vectors will allow many drugs (i.e. from small molecules to monoclonal antibodies) to get past the BBB hurdle and ultimately express their full treatment potential. Accordingly, AngioChem conjugated one of its vectors to paclitaxel, a widely-used drug over the past 10 years in a number of cancer treatments. AngioChem believes that combining paclitaxel with an AngioPep vector will unlock the potential of this drug to treat brain cancer. In addition, choosing paclitaxel as a first conjugate offers a number of potential advantages in terms of quicker time to market and lower development risk, including potential for fast track status.
To date, preclinical data for ANG1005 in animals has been very encouraging. ANG1005 brings at least 50 times more paclitaxel molecules to the brain as compared to paclitaxel alone, it has significantly superior activity, ANG1005 is 3 to 4 times better tolerated than paclitaxel in GLP toxicology studies and finally, ANG1005 is developed in a cremophor-free formulation
About brain cancer
Brain metastasis occurs in 10-15% of cancer patients, with breast, lung and melanoma being the most common cancers to spread to the brain. The predominant, and most aggressive, form of primary brain tumors is glioblastoma. Once diagnosed, the patients' life expectancy is measured in months. Each year, more than 200,000 people in the United States are diagnosed with a primary (20,000) or metastatic brain tumor. Treatment options are scarce and prohibitive, making the cure rate significantly lower than that of many other types of cancer.
AngioChem is a Montreal-based biotechnology company dedicated to creating and developing novel therapies to treat brain diseases. The Company leverages a breakthrough vector technology capable of transporting any size of molecule across the blood-brain barrier (BBB). AngioChem's lead drug candidate is ANG1005, a conjugate consisting of paclitaxel (known as TaxolŽ) with a proprietary peptide vector for the treatment of primary (glioblastoma) and metastatic brain tumors. The Company's portfolio also includes other programs in preclinical stage: ANG-MAb addressing brain cancer and neurodegenerative diseases, and ANG-siRNA for the treatment of neurodegenerative diseases. A detailed description of AngioChem's activities is available at www.angiochem.com
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