Clinical Trials
Active ProgramsBSI-201 Milestones
Triple negative breast cancer (TNBC) - Phase 3
BiPar Sciences initiated a Phase 3 clinical trial in triple negative metastatic breast cancer in July 2009. The study will investigate the safety and efficacy of BSI-201 in combination with gemcitabine and carboplatin as first-, second-, and third-line therapy for patients with metastatic TNBC. All eligible patients enrolled will have the opportunity to receive BSI-201 at some point during the study. The Phase 3 program has been guided by preliminary safety and efficacy data from a Phase 2 study in the same patient population.
For more information about the Phase 3 triple negative breast cancer study, please contact us at (866) 668-2232 or clinicaltrials@BiParSciences.com. You can find complete Phase 3 TNBC trial information at clinicaltrials.gov.
Triple negative breast cancer (neoadjuvant study) - Phase 2
BSI-201is being evaluated as a neoadjuvant combination with chemotherapy in a Phase 2 clinical trial for patients with metastatic triple negative breast cancer. The study will investigate whether patients are responsive to treatment with BSI-201 prior to surgery.
See information about the neoadjuvant breast cancer study on clinicaltrials.gov.
Ovarian Cancer - Phase 2
Two Phase 2 studies evaluating BSI-201 in combination with gemcitabine/carboplatin in platinum-sensitive and platinum-resistant ovarian cancers began in December 2009. A Phase 2a study of BSI-201 in combination with topotecan in patients with advanced ovarian cancer has completed enrollment. The Phase 2 program was guided by gene expression data demonstrating PARP upregulation in specific ovarian tumor classes.
See information about the ovarian cancer studies on clinicaltrials.gov.
Uterine cancer - Phase 2
BiPar Sciences is collaborating with the Gynecologic Oncology Group, a research organization sponsored by the National Cancer Institute, to evaluate BSI-201 in patients with advanced, persistent or recurrent uterine cancer. The Phase 2 program has been guided by gene expression data demonstrating PARP upregulation in specific uterine tumor classes.
See information about the uterine cancer study on clinicaltrials.gov.
Glioblastoma multiforme (GBM) - Phase 1/2
BiPar Sciences is collaborating with the New Approaches to Brain Tumor Therapy (NABTT) consortium, a research organization sponsored by the National Cancer Institute, to evaluate BSI-201 in patients with GBM, the most common brain cancer in adults.
See information about the glioma study at clinicaltrials.gov.
Pancreatic cancer - Phase 1B
BiPar Sciences is investigating BSI-201 in patients with pancreatic cancer with BRCA mutations. Pancreatic cancer is an aggressive disease with limited available treatment options.
See information about the pancreatic cancer study at clinicaltrials.gov.
Lung cancer - Phase 1B
BiPar Sciences is investigating BSI-201 in combination with chemotherapy in non-small cell lung cancer patients. BiPar Sciences is also actively exploring alternative approaches for potential future clinical study in this significant tumor type.
See information about the lung cancer study at clinical trials.gov.
Information about all clinical studies of BSI-201 is available on clinicaltrials.gov.
Recent BSI-201 Clinical Milestones
July 2009 - Phase 3 clinical trial for metastatic triple-negative breast cancer initiated
This study will investigate the safety and efficacy of BSI-201 in combination with gemcitabine/carboplatin as first-, second-, and third-line therapy for patients with metastatic TNBC.
May 2009 - Safety and efficacy profile reported from Phase 2 TNBC study
Preliminary safety and efficacy data from a Phase 2 study of BSI-201 in combination with chemotherapy in patients with triple negative metastatic breast cancer presented at the Plenary Session of the American Society of Clinical Oncology 2009 Annual Meeting held in Orlando, Florida.
December 2008 - Positive safety profile seen in interim Phase 2 results
Reported positive interim safety data from an ongoing Phase 2 study of BSI-201 in combination with chemotherapy in patients with metastatic triple negative breast cancer. BiPar Sciences also presented gene expression data that confirmed significant upregulation of PARP in the tumors of the first 50 patients enrolled in the study. The results were presented at the annual CTRC-AACR San Antonio Breast Cancer Symposium.
June 2008 - Positive Phase 1/1b results
Reported results from Phase 1 monotherapy and Phase 1b combination therapy studies of BSI-201 in patients with advanced solid tumors demonstrating excellent safety profiles and initial indications of clinical benefit. No significant drug-related toxicities were observed. Clinical benefit was reported in 65 percent (59 of 90) of patients. Significant physiological inhibition of PARP was sustained after one cycle of therapy. The clinical findings support the safety of BSI-201 as both monotherapy and in combination with standard-of-care chemotherapies. The results were presented at the annual meeting of the American Society of Clinical Oncology (ASCO).
May 2008 - Start of Phase 2 study in uterine cancer
Initiated Phase 2 study of patients with uterine carcinosarcoma. The multi-center, open-label, single-arm study is evaluating BSI-201 in combination with paclitaxel/carboplatin in patients with recurrent or advanced uterine carcinsarcoma.
May 2008 - Start of Phase 2 study in BRCA-associated ovarian cancer
Initiated Phase 2 study of BSI-201 in BRCA-associated ovarian cancers. Investigators from Memorial Sloan-Kettering Cancer Center are enrolling patients who have a mutation in their BRCA1 or BRCA2 gene.
April 2008 - Positive preclinical data in ovarian cancer
Reported preclinical data that demonstrate activity in ovarian cancer models with BSI-201 both as a single agent and in combination with topotecan. Administered as monotherapy, BSI-201 significantly delayed tumor growth and improved survival. In combination with topotecan, BSI-201 significantly inhibited tumor growth and increased the percentage of complete tumor regressions, compared with topotecan alone. The results were presented at the annual meeting of the American Association for Cancer Research (AACR).
April 2008 - Start of Phase 2 study in glioblastome multiforme
Initiated Phase 2 study in patients with glioblastome multiforme (GBM), the most common brain cancer in adults. The investigation of BSI-201 in the brain tumor setting is enabled by BSI-201's important product attributes: BSI-201 crosses the blood-brain barrier and has a mechanistic basis for synergizing with standard treatment of GBM. Investigators from the New Approaches to Brain Tumor Therapy (NABTT) consortium, a National Cancer Institute-funded research group are conducting the study.
November 2007 - Start of Phase 2 study in triple-negative breast cancer
Initiated Phase 2 study in patients with metastatic triple negative breast cancer. The study design is based on molecular biomarker data demonstrating upregulation of PARP1 in breast tumors that are negative for expression of estrogen-, progesterone-, and HER2 receptors.
November 2007 - Biomarker data show upregulation of PARP in triple negative breast cancer (TNBC)
Reported molecular biomarker data showing significant upregulation of the PARP1 gene in tumors negative for expression of estrogen-, progesterone-, and/or HER2 receptors, compared with receptor-positive subtypes. The data show that PARP1 is upregulated in several primary breast tumor subtypes, including TNBC. These findings support the rationale of PARP inhibition as an effective therapeutic approach to TNBC. The data were presented at the Annual Meeting on Molecular Markers in Cancer of the European Organisation for Research and Treatment of Cancer - National Cancer Institute - American Society for Clinical Oncology
October 2007 - Biomarker data show upregulation of PARP in multiple cancers
Reported molecular biomarker data showing significant upregulation of the PARP1 gene in multiple cancers, including ovarian, breast, and lung tumors. The data were presented at the International Conference on Molecular Targets and Cancer Therapeutics of the American Association for Cancer Research - National Cancer Institute - European Organisation for Research and Treatment of Cancer.