- |||||||||| prexigebersen (BP1001) - Bio / Path
INTERIM SAFETY AND EFFICACY OF BP1001 IN A PHASE II ACUTE MYELOID LEUKEMIA STUDY (Poster Area (Hall 7)) - May 15, 2024 - Abstract #EHA2024EHA_1347; P2a Since >5 responses are observed in both cohorts, the study will continue with enrollment up to 98 and 54 evaluable patients in cohorts 1 and 2, respectively. Efficacy data are encouraging in a challenging population of frontlineadverse-risk, sAML and R/R patients.
- |||||||||| prexigebersen (BP1001) - Bio / Path
Interim safety and efficacy of BP1001 in a phase II acute myeloid leukemia (AML) study. (E450b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1148; P2a Since >5 responses are observed in both cohorts, the study will continue with enrollment up to 98 and 54 evaluable pts in cohorts 1 and 2, respectively. Efficacy data are encouraging in a challenging population of frontline adverse-risk, sAML and R/R pts.
- |||||||||| BP1002 - Bio / Path
Trial completion date, Trial primary completion date, IO biomarker, Metastases: A Clinical Trial of BP1002 in Patients With Advanced Lymphoid Malignancies (clinicaltrials.gov) - Oct 12, 2023 P1, N=30, Recruiting, Trial completion date: Jan 2025 --> Jan 2026 Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Sep 2023 --> Sep 2024
- |||||||||| prexigebersen-A (BP1001-A) - Bio / Path
Enrollment open, Trial completion date, Trial primary completion date, Metastases: BP1001-A in Patients With Advanced or Recurrent Solid Tumors (clinicaltrials.gov) - Aug 23, 2022 P1, N=50, Recruiting, Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Trial completion date: Oct 2023 --> Oct 2024 | Trial primary completion date: Jul 2023 --> Jul 2024
- |||||||||| BP1002 - Bio / Path
Trial completion date, Trial primary completion date, IO biomarker, Metastases: A Clinical Trial of BP1002 in Patients With Advanced Lymphoid Malignancies (clinicaltrials.gov) - Mar 10, 2022 P1, N=30, Recruiting, Initiation date: Apr 2022 --> Jul 2022 Trial completion date: Aug 2022 --> Jan 2024 | Trial primary completion date: Feb 2022 --> Sep 2023
- |||||||||| prexigebersen (BP1001) - Bio / Path
Trial completion date, Trial primary completion date, Combination therapy: BP1001-201-AML: Clinical Trial of BP1001 in Combination With With Venetoclax Plus Decitabine in AML (clinicaltrials.gov) - Jan 4, 2022 P2a, N=108, Recruiting, Together these results strongly suggest that BP1003 combination therapy is a novel strategy for patients with advanced solid tumors. Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022
- |||||||||| prexigebersen-A (BP1001-A) - Bio / Path
Trial completion date, Trial primary completion date, Metastases: BP1001-A in Patients With Advanced or Recurrent Solid Tumors (clinicaltrials.gov) - Dec 22, 2021 P1, N=50, Not yet recruiting, Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022 Trial completion date: Oct 2022 --> Oct 2023 | Trial primary completion date: Jul 2022 --> Jul 2023
- |||||||||| prexigebersen (BP1001) - Bio / Path
Review, Journal: The Challenges and Strategies of Antisense Oligonucleotide Drug Delivery. (Pubmed Central) - May 1, 2021 Focusing on liposomal delivery, we will specifically describe liposome-incorporated growth factor receptor-bound protein-2 (Grb2) antisense oligodeoxynucleotide BP1001...Additionally, its enhanced biodistribution makes it an attractive therapeutic modality for hematologic malignancies as well as solid tumors. A detailed understanding of the obstacles that ASOs face prior to reaching their targets and continued advances in methods to overcome them will allow us to harness ASOs' full potential in precision medicine.
- |||||||||| BP1002 - Bio / Path
Trial completion date, Trial primary completion date, IO biomarker, Metastases: A Clinical Trial of BP1002 in Patients With Advanced Lymphoid Malignancies (clinicaltrials.gov) - Jan 27, 2021 P1, N=30, Recruiting, These promising preclinical results suggest that the BP1002 plus decitabine combination is a potential treatment for patients who have relapsed from frontline venetoclax-based therapies. Trial completion date: Aug 2021 --> Aug 2022 | Trial primary completion date: Feb 2021 --> Feb 2022
- |||||||||| prexigebersen-A (BP1001-A) - Bio / Path
Trial completion date, Trial primary completion date, Metastases: BP1001-A in Patients With Advanced or Recurrent Solid Tumors (clinicaltrials.gov) - Jan 26, 2021 P1, N=50, Not yet recruiting, Trial completion date: Aug 2021 --> Aug 2022 | Trial primary completion date: Feb 2021 --> Feb 2022 Trial completion date: Oct 2021 --> Oct 2022 | Trial primary completion date: Jul 2021 --> Jul 2022
- |||||||||| BP1003 - Bio / path, liposomal Bcl2 (BP1002) - Bio / path, prexigebersen (BP1001) - Bio / path
[VIRTUAL] Bio-Path Holdings Inc. () - Jun 9, 2020 - Abstract #BIO2020BIO_130; Bio-Path is initiating a Phase 1 study of its 2nd pipeline candidate, BP1002 (liposomal Bcl-2), in the 1st half of 2020 to evaluate the ability of BP1002 to treat refractory/relapsed lymphoma and chronic lymphocytic leukemia patients. And BioPath is nearing completion of IND-enabling studies of BP1003, a novel liposome- incorporated STAT3.
- |||||||||| prexigebersen (BP1001) - Bio / Path
Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date, Combination therapy: Clinical Trial of BP1001 (Liposomal Grb2 Antisense Oligonucleotide) in Combination With Dasatinib in Patients With Ph + CML Who Have Failed TKI, Ph+ AML, Ph+ MDS (clinicaltrials.gov) - May 28, 2020 P1/2, N=0, Withdrawn, And BioPath is nearing completion of IND-enabling studies of BP1003, a novel liposome- incorporated STAT3. N=46 --> 0 | Trial completion date: Dec 2021 --> May 2020 | Recruiting --> Withdrawn | Trial primary completion date: Dec 2020 --> May 2020
- |||||||||| BP1002 - Bio / Path
Trial initiation date, IO biomarker, Metastases: A Clinical Trial of BP1002 in Patients With Advanced Lymphoid Malignancies (clinicaltrials.gov) - May 27, 2020 P1, N=30, Not yet recruiting, N=46 --> 0 | Trial completion date: Dec 2021 --> May 2020 | Recruiting --> Withdrawn | Trial primary completion date: Dec 2020 --> May 2020 Initiation date: Feb 2020 --> Jun 2020
- |||||||||| liposomal Bcl2 (BP1002) - Bio / path
[VIRTUAL] A phase I clinical trial to study the safety, pharmacokinetics, and efficacy of BP1002 (L-Bcl-2) antisense oligonucleotide in patients with advanced lymphoid malignancies (Virtual Meeting: All Session Times Are U.S. EDT) - Apr 13, 2020 - Abstract #AACRI2020AACR-I_421; The dose below that will be the maximum tolerated dose (MTD). The RP2D will be determined using the MTD data and all information regarding safety, biological activity, PK and pharmacodynamics.Primary objectives: To determine•Safety and tolerability of escalating doses of BP1002•RP2D of BP1002•PK of BP1002•BP1002 activity on Bcl-2 expressionSecondary objectives: To obtain evidence of tumor response (overall response rate = complete remission + partial remission + minor response), and estimates for other response parameters (time to progression, progression-free survival, event-free survival)Exploratory objectives: To correlate treatment response with biological activity, cytogenetic and molecular characteristicsSafety assessments will include identification of DLTs, serious adverse events, treatment-emergent adverse events and treatment-emergent laboratory abnormalitiesResponse assessments will be determined per the 2018 International Workshop Group on CLL (iwCLL) response criteria, the International Working Group consensus response evaluation criteria in lymphoma (RECIL 2017), or the Eighth International Workshop for Waldenströms Macroglobulinemia response criteria.
- |||||||||| prexigebersen (BP1001) - Bio / Path
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy: BP1001-201-AML: Clinical Trial of BP1001 in Combination With With Venetoclax Plus Decitabine in AML (clinicaltrials.gov) - Jan 25, 2019 P2a, N=108, Recruiting, Trial completion date: Dec 2019 --> Dec 2021 | Trial primary completion date: Dec 2019 --> Dec 2021 N=54 --> 108 | Trial completion date: Dec 2018 --> Dec 2019 | Trial primary completion date: Dec 2018 --> Dec 2019
- |||||||||| prexigebersen (BP1001) - Bio / Path
Trial primary completion date: Clinical Trial of BP1001 (L-Grb-2 Antisense Oligonucleotide) in CML, AML, ALL & MDS (clinicaltrials.gov) - Jan 18, 2018 P1, N=60, Active, not recruiting, To further explore this anti-leukaemic activity, the efficacy of BP1001 plus low-dose cytarabine combination is being investigated in an ongoing phase 2 study in patients with previously untreated acute myeloid leukaemia who are ineligible for intensive induction therapy. Trial primary completion date: Sep 2017 --> Dec 2019
|