Clinical Trials
Active ProgramsIniparib (BSI-201) Milestones
Metastatic triple-negative breast cancer - Expanded Access Protocol (EAP)
Iniparib (BSI-201) Expanded Access Protocol Approved
BiPar Sciences and sanofi-aventis recently obtained U.S. Food and Drug Administration (FDA) approval for an Expanded Access Protocol (EAP) for iniparib, the United States Adopted Name (USAN) for the investigational PARP1 inhibitor, BSI-201, in metastatic triple negative breast cancer (mTNBC). Women in the United States with no comparable or satisfactory treatment options for mTNBC, and who do not qualify for an appropriate clinical trial, have the opportunity to access to the investigational compound BSI-201 through the EAP. It is important to note that iniparib has not yet been approved by the FDA as safe and effective.
The company is now working with oncologists to open the EAP at sites around the country. Sites will open at different times, depending on a variety of issues, including approval by local institutional review boards. To enroll in the EAP, a woman must meet specific clinical criteria which her healthcare professional will assess. A random selection process will ensure that all women with mTNBC who meet these criteria have equal opportunity to access the compound.
Patients and healthcare professionals can learn more about the iniparib EAP at clinicaltrials.gov or by calling the information hotline +1 866 668 2232.
For more information about the iniparib EAP, click here.
Metastatic triple negative breast cancer (mTNBC) - Phase 3
BiPar Sciences initiated a Phase 3 clinical trial in triple negative metastatic breast cancer in July 2009. This study has now completed enrollment.
This study is investigating the safety and efficacy of iniparib in combination with gemcitabine and carboplatin as first-, second-, and third-line therapy for patients with metastatic TNBC. All eligible patients enrolled have the opportunity to receive iniparib at some point during the study.
Squamous Cell Lung Cancer - Phase 3
BiParSciences is investigating iniparib in combination with chemotherapy as first-line therapy for patients with advanced squamous cell lung cancer.
See information about the lung cancer study at clinicaltrials.gov or call the BiPar Sciences Call Center at 1-866-668-2232.
Triple negative breast cancer (neoadjuvant study) - Phase 2
Iniparib is being evaluated as a neoadjuvant combination with chemotherapy in a Phase 2 clinical trial for patients with triple negative breast cancer. The study will investigate whether patients are responsive to treatment with iniparib prior to surgery.
See information about the neoadjuvant breast cancer study on clinicaltrials.gov.
Ovarian Cancer - Phase 2
Two Phase 2 studies evaluating iniparib in combination with gemcitabine/carboplatin in platinum-sensitive and platinum-resistant ovarian cancers began in December 2009. A Phase 2a study of iniparib 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 iniparib 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 iniparib 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 iniparib 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.
Information about all clinical studies of iniparib is available on clinicaltrials.gov.
Recent BSI-201 Clinical Milestones
March 2010 - Phase 3 clinical trial for squamous cell lung cancer initiated
This study is investigating the safety and efficacy of iniparib in combination with gemcitabine/carboplatin as first-line therapy for patients with advanced squamous cell lung cancer.
July 2009 - Phase 3 clinical trial for metastatic triple-negative breast cancer initiated
This study is investigating the safety and efficacy of iniparib in combination with gemcitabine/carboplatin as first-, second-, and third-line therapy for patients with metastatic TNBC. Enrollment for the trial is now closed.
May 2009 - Safety and efficacy profile reported from Phase 2 TNBC study
Preliminary safety and efficacy data from a Phase 2 study of iniparib in combination with chemotherapy in patients with metastatic TNBC were 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 iniparib in combination with chemotherapy in patients with metastatic TNBC. 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 iniparib in patients with advanced solid tumors demonstrated. 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 iniparib 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 iniparib 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 demonstrated activity in ovarian cancer models with iniparib both as a single agent and in combination with topotecan. Administered as monotherapy, iniparib significantly delayed tumor growth and improved survival. In combination with topotecan, iniparib 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 iniparib in the brain tumor setting is enabled by BSI-201's product attributes: iniparib crosses the blood-brain barrier and has a mechanistic basis for synergizing with standard treatment of GBM. Investigators from the Adult Brain Tumor Consortium (ABTC, formerly 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.