ANGIOCHEM TO PRESENT POSITIVE CNS and peripheral anti-tumor activity of ANG1005 IN PATIENTS WITH BRAIN METASTASES FROM BREAST CANCERS AND OTHER ADVANCED SOLID TUMORS AT ASCO (2014 ANNUAL MEETING)
Phase 2 Clinical Study of ANG1005 in HER2+ Breast Cancer Patients with Brain Metastases Initiated
Montreal, Canada, May 30, 2014 – Angiochem, a clinical stage biotechnology company developing drugs that are uniquely capable of crossing the blood-brain barrier (BBB), today announced the presentation of data for its lead drug candidate, ANG1005, a novel paclitaxel-peptide drug conjugate, at the American Society of Clinical Oncology 50th Annual Meeting in Chicago, IL. Phase 1 and Phase 2 clinical studies demonstrated promising signs of both CNS and peripheral anti-tumor activity of ANG1005 in patients with brain metastases including breast cancer patients. Based on these data, Angiochem also announced today that the company has initiated a Phase 2b clinical trial with ANG1005 designed to confirm this anti-tumor activity as a potential new approach to treating HER2+ breast cancer.
"The data being presented on our lead product candidate, ANG1005, underscores its potential utility in treating brain and peripheral metastases from breast cancer and other solid tumors," said Jean Paul Castaigne, M.D., President and CEO of Angiochem. "Effective management of patients with brain metastases continues to be a major clinical challenge. By actively penetrating the blood-brain barrier and cancer cells through LRP-1 receptor, ANG1005 elicits both CNS and peripheral tumor responses and provides a potential new treatment option for this difficult to treat patient population."
The data to be presented at ASCO includes results from a Phase 1 and initial Phase 2 clinical studies of ANG1005 in HER2+ positive and HER2-negative breast cancer patients and solid tumors with brain metastasis in which promising signs of anti-tumor activity were observed both in CNS and at the periphery. These studies support the advancement of the newly-initiated comprehensive Phase 2 clinical study for ANG1005 in HER2+ breast cancer patients with brain metastases.
ANG1005 represents a first-in-class oncology product that leverages the low density lipoprotein receptor-related protein 1 (LRP-1) pathway to cross the blood-brain barrier (BBB) and enter cancer cells. In addition to the newly-initiated comprehensive Phase 2 clinical study in patients with progressive or recurrent brain metastases from HER2+ breast cancer, ANG1005 is also being evaluated in an ongoing Phase 2 clinical study in patients with primary brain cancers such as recurrent glioblastoma multiforme (GBM) and anaplastic glioma.
In a poster presentation entitled "Evaluation of CNS and peripheral antitumor activity of ANG1005 in patients with brain metastases from breast tumors and other advanced solid tumors," Nancy U. Lin, M.D., Clinical Director Breast Oncology at the Dana Faber Cancer Institute will present Phase 1 and Phase 2 clinical data which demonstrated the anti-tumor activity of ANG1005 on CNS tumors and peripheral metastasis, providing additional patient benefit.
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In a Phase 1 dose escalating (30 to 700 mg/m2) clinical study of ANG1005 in solid tumors with progressive brain metastases 21 patients dosed with ANG1005 at ≥ 420 mg/m2 were evaluated for response including overall tumor response (CNS and peripheral).
- CNS: Four (22%) achieved partial responses (PR) and ten (56%) achieved stable disease
- Peripheral: Four (25%) achieved partial responses and 7 (44%) achieved stable disease
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In a Phase 2 open-label, single arms study with two cohorts (HER2+ and HER2-) breast cancer patients with brain metastases 61 and 32 patients were evaluated for CNS and peripheral tumor response per RECIST criteria at the dose of ANG1005 at 550 mg/m2 or 650 mg/m2
- CNS: 15 (25%) achieved partial responses and 34 (56%) achieved stable disease
- Peripheral: 8 (25%) achieved partial responses and 16 (50%) achieved stable disease
About ANG1005
ANG1005 is a novel paclitaxel-peptide drug conjugate that represents the first oncology product to leverage the low density lipoprotein receptor-related protein 1 (LRP-1) pathway to cross the blood-brain barrier (BBB) and enter cancer cells. ANG1005 has been studied in over 200 patients in three clinical studies; two phase 1 studies where the product has shown tolerability similar to paclitaxel and indications of activity, and a Phase 2 study for which the intent-to-treat (ITT) analysis demonstrated encouraging signs of anti-tumor activity and was reported at the 2013 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference. A multi-study Phase 2 clinical program is underway to further confirm the clinical activity of ANG1005 observed in these earlier studies, including a Phase 2 clinical study in patients with primary brain cancers such as recurrent glioblastoma multiforme (GBM) and anaplastic glioma and a Phase 2 clinical study in in HER2+breast cancer patients.
Angiochem is a clinical-stage biotechnology company discovering and developing new breakthrough peptide drug conjugates that leverage the LRP-1 mediated pathway to cross the BBB to treat neurological diseases. These new compounds have the potential to address significant medical needs, many of which are insurmountable due to the fundamental physiological challenge posed by the BBB.
Angiochem is developing a focused product pipeline, including small molecules and biologics, for the potential treatment of a wide range of CNS diseases, including primary brain cancer, brain metastases, lysosomal storage diseases and pain. Founded in 2003, Angiochem maintains headquarters in Montreal, Canada. For additional information about the Company, please visit http://www.angiochem.com.
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ANGIOCHEM INITIATES PHASE 2 CLINICAL STUDY FOR LEAD DRUG CANDIDATE, ANG1005, IN HER2+ BREAST CANCER WITH BRAIN METASTASES
Novel Peptide Drug Conjugate to Target HER2+ Breast Cancer Patients with Progressive or Recurrent Brain Metastases, a Cancer with High Unmet Medical Need
Montreal, Canada, May 30, 2014 – Angiochem, a clinical stage biotechnology company developing drugs that are uniquely capable of crossing the blood-brain barrier (BBB), today announced the initiation of a Phase 2 clinical study with ANG1005, a novel paclitaxel-peptide drug conjugate, in HER2+breast cancer patients. This study is designed to evaluate the anti-tumor activity of ANG1005 as a new approach to treating HER2+ breast cancer patients with progressive or recurrent brain metastases. This Phase 2 clinical study follows three separate, previously completed, clinical studies of ANG1005 in patients with a variety of solid tumor cancers including a Phase 2 clinical study in HER2-positive and HER2-negative breast cancer patients with brain metastasis in which promising signs of anti-tumor activity were observed supporting the Company's decision to advance the ANG1005 clinical development program.
"We are excited to advance ANG1005 into further clinical development for HER2+ breast cancer," said Jean-Paul Castaigne, MD, CEO of Angiochem. "Progressive or recurrent brain metastases in this patient population continues to be a major clinical challenge and area of significant unmet need for innovative new treatments. In preclinical and early clinical studies, ANG1005 has demonstrated the ability to cross the blood-brain barrier, offering the potential for significant benefit to this patient population with a very challenging cancer."
This Phase 2 clinical study is designed to evaluate the anti-tumor activity of ANG1005 in up to 40 patients with progressive or recurrent HER2+ breast cancer at approximately 10 U.S. clinical sites. Study endpoints include objective response rate, progression-free survival, overall survival and duration of response, in addition to safety and tolerability. For more information about the study please refer to www.clinicaltrials.gov.
About ANG1005
ANG1005 is a novel paclitaxel-peptide drug conjugate that represents the first oncology product to leverage the low density lipoprotein receptor-related protein 1 (LRP-1) pathway to cross the blood-brain barrier (BBB) and enter cancer cells. ANG1005 has been studied in over 200 patients in three clinical studies; two phase 1 studies where the product has shown tolerability similar to paclitaxel and indications of activity, and a Phase 2 study for which the intent-to-treat (ITT) analysis demonstrated encouraging signs of anti-tumor activity and was reported at the 2013 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference. A multi-study Phase 2 clinical program is underway to further confirm the clinical activity of ANG1005 observed in these earlier studies, including a Phase 2 clinical study in patients with primary brain cancers such as recurrent glioblastoma multiforme (GBM) and anaplastic glioma and a Phase 2 clinical study in in HER2+breast cancer patients.
Angiochem is a clinical-stage biotechnology company discovering and developing new breakthrough peptide drug conjugates that leverage the LRP-1 mediated pathway to cross the BBB to treat neurological diseases. These new compounds have the potential to address significant medical needs, many of which are insurmountable due to the fundamental physiological challenge posed by the BBB.
Angiochem is developing a focused product pipeline, including small molecules and biologics, for the potential treatment of a wide range of CNS diseases, including primary brain cancer, brain metastases, lysosomal storage diseases and pain. Founded in 2003, Angiochem maintains headquarters in Montreal, Canada. For additional information about the Company, please visit http://www.angiochem.com.
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Angiochem's ANG1005 Received Fast Track and Orphan Drug Designation from FDA for the Treatment of Glioblastoma Multiforme
Montreal, Canada, May 30, 2014 - Angiochem announced today that the Food & Drug Association (FDA) has granted both orphan drug and fast track designation to ANG1005 a novel paclitaxel-peptide drug conjugate leveraging the low density lipoprotein receptor-related protein 1 (LRP-1) pathway to cross the blood-brain barrier (BBB) and enter cancer, for the treatment of glioblastoma multiforme (GBM).
"We are pleased that the FDA supports our applications for both fast track and orphan drug designation for ANG1005 for the treatment of glioblastoma multiforme. These are important regulatory milestones for the program," commented Dr. Jean Paul Castaigne MD CEO of Angiochem. "We will continue to work closely with the FDA as we advance ANG1005 through clinical development and the associated regulatory processes."
Fast track designation is granted by the FDA to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designation confers some or all of the following benefits: more frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval, more frequent written correspondence from FDA about such things as the design of the proposed clinical trials and use of biomarkers, eligibility for accelerated approval and priority review, if relevant criteria are met, and rolling review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed.
Orphan drug status is granted by the FDA to promote the development of promising therapeutics for the treatment of rare diseases affecting fewer than 200,000 people in the US annually. Orphan drug designation includes benefits such as a seven-year period of marketing exclusivity in the United States after approval. Other potential advantages come in the form of protocol assistance, the ability to apply for research funding, tax credits for certain research expenses, and fee waivers for the regulatory procedures.
ANG1005 is a novel paclitaxel-peptide drug conjugate that represents the first oncology product to leverage the low density lipoprotein receptor-related protein 1 (LRP-1) pathway to cross the blood-brain barrier (BBB) and enter cancer cells is currently in phase 2 clinical development in high-grade gliomas and brain metastasis from breast cancer.
About Glioblastoma multiforme (GBM)
Glioblastoma multiforme (GBM) (also called glioblastoma) are fast-growing, invasive types of glial tumors, commonly spreading to nearby brain tissue. The National Cancer Institute estimates that there will be 23,380 new cases of brain and other nervous system tumors diagnosed in 2014. It also estimates that in 2014, 14,320 people will die of this disease.
About ANG1005
ANG1005 is a novel paclitaxel-peptide drug conjugate that represents the first oncology product to leverage the low density lipoprotein receptor-related protein 1 (LRP-1) pathway to cross the blood-brain barrier (BBB) and enter cancer cells. ANG1005 has been studied in over 200 patients in three clinical studies; two phase 1 studies where the product has shown tolerability similar to paclitaxel and indications of activity, and a Phase 2 study for which the intent-to-treat (ITT) analysis demonstrated encouraging signs of anti-tumor activity and was reported at the 2013 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference. A multi-study Phase 2 clinical program is underway to further confirm the clinical activity of ANG1005 observed in these earlier studies, including a Phase 2 clinical study in patients with primary brain cancers such as recurrent glioblastoma multiforme (GBM) and anaplastic glioma and a Phase 2 clinical study in in HER2+breast cancer patients.
Angiochem is a clinical-stage biotechnology company discovering and developing new breakthrough peptide drug conjugates that leverage the LRP-1 mediated pathway to cross the BBB to treat neurological diseases. These new compounds have the potential to address significant medical needs, many of which are insurmountable due to the fundamental physiological challenge posed by the BBB.
Angiochem is developing a focused product pipeline, including small molecules and biologics, for the potential treatment of a wide range of CNS diseases, including primary brain cancer, brain metastases, lysosomal storage diseases and pain. Founded in 2003, Angiochem maintains headquarters in Montreal, Canada. For additional information about the Company, please visit http://www.angiochem.com.