Angiochem`s ANG1005 Demonstrates Safety and Efficacy in Phase 1/2Brain Cancer Studies

Mon Oct 19, 2009 7:00am EDT
 
[-] Text [+]
- ANG1005 Crosses the Blood-Brain Barrier to Reduce Tumor Size and is Effective
in Resistant Tumors -

- Angiochem`s EPiC platform validated in humans: EPiC Drugs Cross Blood-Brain
Barrier -
MONTREAL & CHICAGO--(Business Wire)--
Angiochem, Inc. a clinical-stage biotechnology company developing drugs that are
uniquely capable of crossing the blood-brain barrier to treat brain diseases,
announced today that its lead drug candidate, ANG1005, has demonstrated a
favorable safety and efficacy profile in more than 100 patients with brain
cancer from two separate Phase 1 /2 clinical studies in patients with
progressive gliomas, including recurrent glioblastoma, and in patients with
progressive brain metastases. These data, which validates in humans Angiochem`s
peptide-based platform technology (EPiC), were presented at the Society for
Neuroscience Annual Meeting in Chicago on October 18, 2009. 

In the recently completed Phase 1/2 brain metastases clinical trial, greater
than 70% of patients receiving therapeutic doses experienced disease control
(stable disease or better) with more than half of them showing clear reduction
in tumor size. Furthermore, 78% of patients with taxane resistant tumors showed
responses, indicating ANG1005 has the potential to be effective against
resistant tumors. Of significance, therapeutic doses of ANG1005 were present in
patient brain tumor samples, indicating that the drug successfully crosses the
blood-brain barrier (BBB) and concentrates in the tumor, without showing central
nervous system (CNS) toxicity or immunogenicity. Similar trends in patient
responses have been observed to-date in the on-going Phase 1/2 recurrent
glioblastoma clinical trial with approximately 65% of patients experiencing
disease control. 

"It is highly encouraging to see that ANG1005 has shown the potential to be
effective in metastatic brain cancers and against drug resistant tumors, that
are highly aggressive and have few treatment options," commented Jan Drappatz,
MD, Center for Neuro-Oncology at Dana-Farber Cancer Institute, Department of
Neurology at Brigham and Women`s Hospital, and, Harvard Medical School, and lead
investigator for Boston-area study centers. "Furthermore, significant reductions
in tumor size and reversal of neurological deficits were observed in several
cases of patients with high-grade gliomas in the on-going clinical trial. We are
very encouraged by these efficacy signals and look forward to learning more
about the effects of ANG1005 in recurrent glioblastoma as the study progresses."


ANG1005 is a novel, next-generation taxane derivative, targeting the LRP pathway
to cross the blood-brain barrier and reach therapeutic concentrations in the
brain. The drug was created with Angiochem`s Engineered Peptide Compound (EPiC)
platform technology. Key findings to date from the clinical studies include:

* 71% of patients (15/ 21) demonstrated disease control at therapeutic doses
including seven partial responses (PR), four minor responses (MR) and four with
stable disease (SD). 
* 78% of patients with taxane resistant tumors (7/9) demonstrated responses
indicating ANG1005 is effective in resistant tumors, including three PRs and
four MRs. 
* Similar responses were observed in metastases located in other organs such as
liver, lung, lymph nodes and bone including two complete responses (CR), one in
liver and one in bone. 
* Therapeutic concentrations of ANG1005 were present in patient brain tumor
samples, indicating the drug successfully crosses the BBB and enters the tumor. 
* No CNS toxicity as measured by neurocognitive testing was observed. 
* No immunogenicity or antibody response was observed, even after repeated
dosing. 
* Superior side-effect profile compared to other taxanes was observed based on
literature references. 
* Similar trends in patient responses have been observed to date in the on-going
recurrent glioblastoma trial with 65% of patients experiencing disease control.

In addition to the ANG1005 clinical findings, Angiochem`s EPiC technology was
also highlighted at the Neurosciences meeting. In a presentation entitled
"Development of a New Engineered Peptide Compound (EPiC) Platform for the
Transport of Small and Large Therapeutics to the CNS", Jean-Paul Castaigne, MD,
discussed the science underlying the EPiC technology and disclosed evidence of
its ability to increase the amount of a variety of different therapeutics to
reach the brain, highlighting the potential neurological applications of this
technology and speed at which new drugs could be developed. 

"We are excited by our positive results to date with ANG1005, which strongly
validate our platform technology in humans," commented Jean-Paul Castaigne, MD,
MBA, President and CEO of Angiochem. "Through our peptide-based platform
technology, called EPiC, Angiochem creates new chemical entities that can cross
the human blood-brain barrier to reach therapeutic concentration in the brain.
By harnessing naturally-occurring receptors at the surface of the BBB, our EPiC
drugs have the potential to treat a variety of CNS diseases, including
neurodegenerative and metabolic diseases, brain cancer, psychiatric disorders
and many others." 

Scientific Breakfast Symposium // Angiochem is also sponsoring a Scientific
Breakfast Symposium during the Society for Neuroscience annual meeting, entitled
"Crossing The Blood-Brain Barrier: New Therapeutic Approaches", on Monday,
October 19, 2009, 6:30 - 8:30 a.m. CT., at the Hyatt Regency McCormick Place,
Room CC10CD - Level 1. This scientific symposium includes presentations and Q&A
with leading scientific, medical and industry experts in the areas of CNS and
oncology. The event will also be webcast and available after 11:30am on October
19 on the Angiochem website (http://www.angiochem.com) or directly at:
http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c#2273&eventID$82177.

About ANG1005 // ANG1005 is a novel, next-generation taxane derivative targeting
the LRP pathway. ANG1005 was engineered with the EPiC platform which was
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 gliomas and metastatic brain cancers. 

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 (BBB) to treat brain diseases. The company`s
proprietary Engineered Peptide Compounds (EPiC) technology creates drugs that
cross the BBB and reach therapeutic concentration in the brain, by harnessing
naturally-occurring receptors on the surface of the BBB. Angiochem`s lead
product candidate, ANG1005 is in two separate Phase 1/2 clinical studies in
patients with brain cancers and cancer metastases. Additionally, Angiochem is
developing a deep and broad product pipeline, including small and large
molecules, for the potential treatment of a wide range of CNS diseases,
including neurodegenerative and metabolic diseases, brain cancer, psychiatric
disorders and many others. Founded in 2006, Angiochem maintains headquarters in
Montreal, Canada. For additional information about the Company, please visit
http://www.angiochem.com. 

Copyright 2009 Angiochem, Inc. 

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Copyright Business Wire 2009

 

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