Burzynski Research (BZYR) 0.1100 $BZYR
Burzynski Research Institute awarded US FDA's approval to begin new clinical trial in Diffuse Intrinsic Brainstem Glioma
M2 - Mon Oct 27, 6:20AM CDT
Biopharmaceutical company Burzynski Research Institute (Other OTC:BZYR) revealed on Friday that it has received approval from the US Food and Drug Administration (FDA) to conduct an open-label study of Antineoplastons A10 and AS2-1 in patients > three months of age with a diffuse intrinsic brainstem glioma (DIPG), the most common brainstem tumor in children.
Burzynski Research Institute, Inc. Announces FDA Permission to Launch a New Clinical Trial in Diffuse Intrinsic Brainstem Glioma
PR Newswire - Fri Oct 24, 4:50PM CDT
Burzynski Research Institute, Inc. (BRI) announced today that the U.S. Food and Drug Administration (FDA) has given the company permission to conduct an open-label study of Antineoplastons A10 and AS2-1 in patients > 3 months of age with a diffuse intrinsic brainstem glioma (DIPG). Study subjects will be placed in one of five treatment groups based on their age and whether or not they have received prior treatment for DIPG. The primary study endpoint is a decrease in the size of the tumor, either a partial response (greater-than or equal to 50% decrease in the size of the tumor) or a complete response (disappearance of the tumor). The study is in its final organizational stage and will begin accruing patients as soon as this organizational stage is completed.
Burzynski Research Institute, Inc. Announces Presentations at the 16th International Symposium on Pediatric Neuro-Oncology
PR Newswire - Fri Jun 27, 12:08PM CDT
The Burzynski Research Institute, Inc. (BRI) announced today that it will present data on two of the Company's clinical-stage product candidates, Antineoplaston A10 injections (Atengenal®) and Antineoplaston AS2-1 injections (Astugenal®), at the 16th International Symposium on Pediatric Neuro-Oncology held in Singapore from June 28, 2014 to July 2, 2014. Abstracts and presentations are now available to the public in an online supplement in the journal, Neuro-Oncology (Neuro Oncol 2014 June; 16(Suppl 1): i1-i157). The abstract numbers are CT-004, HG-017, and MB-039. The journal's TOC web address is http://neuro-oncology.oxfordjournals.org/cont...uppl_1.toc.
Burzynski Research Institute, Inc. Announces Lifting of the FDA Partial Clinical Hold - Phase 3 Clinical Study Agreed Upon
PR Newswire - Mon Jun 23, 3:07PM CDT
The Burzynski Research Institute, Inc. (BRI) announced today that U.S. Food and Drug Administration (FDA) has notified the company that its partial clinical hold on its IND for Antineoplastons A10/AS2-1 Injections has been lifted. The FDA has determined that under its IND the Company may initiate its planned Phase 3 study in newly diagnosed diffuse, intrinsic, brainstem glioma. The Company is continuing discussions with the Agency in an effort to finalize additional details of the phase 3 study protocol for the potential clinical trial.
Burzynski Research Institute awarded US FDA's approval to begin new clinical trial in Diffuse Intrinsic Brainstem Glioma
M2 - Mon Oct 27, 6:20AM CDT
Biopharmaceutical company Burzynski Research Institute (Other OTC:BZYR) revealed on Friday that it has received approval from the US Food and Drug Administration (FDA) to conduct an open-label study of Antineoplastons A10 and AS2-1 in patients > three months of age with a diffuse intrinsic brainstem glioma (DIPG), the most common brainstem tumor in children.
Burzynski Research Institute, Inc. Announces FDA Permission to Launch a New Clinical Trial in Diffuse Intrinsic Brainstem Glioma
PR Newswire - Fri Oct 24, 4:50PM CDT
Burzynski Research Institute, Inc. (BRI) announced today that the U.S. Food and Drug Administration (FDA) has given the company permission to conduct an open-label study of Antineoplastons A10 and AS2-1 in patients > 3 months of age with a diffuse intrinsic brainstem glioma (DIPG). Study subjects will be placed in one of five treatment groups based on their age and whether or not they have received prior treatment for DIPG. The primary study endpoint is a decrease in the size of the tumor, either a partial response (greater-than or equal to 50% decrease in the size of the tumor) or a complete response (disappearance of the tumor). The study is in its final organizational stage and will begin accruing patients as soon as this organizational stage is completed.
Burzynski Research Institute, Inc. Announces Presentations at the 16th International Symposium on Pediatric Neuro-Oncology
PR Newswire - Fri Jun 27, 12:08PM CDT
The Burzynski Research Institute, Inc. (BRI) announced today that it will present data on two of the Company's clinical-stage product candidates, Antineoplaston A10 injections (Atengenal®) and Antineoplaston AS2-1 injections (Astugenal®), at the 16th International Symposium on Pediatric Neuro-Oncology held in Singapore from June 28, 2014 to July 2, 2014. Abstracts and presentations are now available to the public in an online supplement in the journal, Neuro-Oncology (Neuro Oncol 2014 June; 16(Suppl 1): i1-i157). The abstract numbers are CT-004, HG-017, and MB-039. The journal's TOC web address is http://neuro-oncology.oxfordjournals.org/cont...uppl_1.toc.
Burzynski Research Institute, Inc. Announces Lifting of the FDA Partial Clinical Hold - Phase 3 Clinical Study Agreed Upon
PR Newswire - Mon Jun 23, 3:07PM CDT
The Burzynski Research Institute, Inc. (BRI) announced today that U.S. Food and Drug Administration (FDA) has notified the company that its partial clinical hold on its IND for Antineoplastons A10/AS2-1 Injections has been lifted. The FDA has determined that under its IND the Company may initiate its planned Phase 3 study in newly diagnosed diffuse, intrinsic, brainstem glioma. The Company is continuing discussions with the Agency in an effort to finalize additional details of the phase 3 study protocol for the potential clinical trial.
