FDA Grants Orphan Drug And Fast Track Status To Angiochem's Ang1005 For Brain Tumors
By Cyndi Root
Angiochem announced in a press release that the Food & Drug Association (FDA) has granted Orphan Drug and Fast Track designation to ANG1005. The paclitaxel-peptide drug conjugate is for the treatment of glioblastoma multiforme (GBM), a tumor that spreads to brain tissue. Fast Track allows more frequent communications with the FDA and Orphan status provides marketing exclusivity if the drug is approved, among other benefits.
Jean Paul Castaigne, MD, CEO of Angiochem, said, “These are important regulatory milestones for the program. We will continue to work closely with the FDA as we advance ANG1005 through clinical development and the associated regulatory processes."
Ang1005
Ang1005 is a drug conjugate that uses the low density lipoprotein receptor-related protein 1 (LRP-1) pathway. By leveraging this pathway, the drug is able to cross the blood-brain barrier (BBB) and engage the glioblastoma multiforme (GBM).
ANG1005 is the first (LRP-1) agent and is currently in Phase II studies. In three clinical studies of 200 patients, Ang1005 showed tolerability and anti-tumor activity. Results were reported at the 2013 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference. The Phase II program for Ang1005 is a multi-study clinical program. Studies will confirm earlier study results including studies with GBM, anaplastic glioma, and HER2+ breast cancer patients.
Glioblastoma Multiforme
Glioblastoma multiforme (GBM), also known as glioblastoma, is an invasive type of glial tumor that grows quickly and invades brain tissue. The tumor develops from astrocytes — glial cells that support nerve cells — though the tumor may also develop from other cells such as oligodendrocytes. Most common in older adults, tumors usually occur in the frontal and temporal lobes. GBMs are aggressive and deadly, usually causing death within 15 months after diagnosis. Over 20,000 cases of GBM are diagnosed annually.
About Angiochem
Angiochem is headquartered in Montreal, Canada and was founded in 2003. The company focuses on clinical stage discovery of new peptide drug conjugates. Its compounds leverage the LRP-1 mediated pathway and can cross the blood-brain barrier, a significant hurdle in treating neurological diseases. Angiochem also develops small molecules and biologics. Areas of focus include CNS diseases, such as brain cancer and pain.