Thiotepa

Orca Bio Presents Promising Data on Orca-T in Two Oral Presentations at the 2024 Tandem Meetings of ASTCT® and CIBMTR®

Retrieved on: 
Friday, February 23, 2024
Research, Infectious Diseases, Clinical Trials, Stem Cells, Biotechnology, Health, Pharmaceutical, Science, Oncology, MAC, AML, Syndrome, MD, Assistant, Physician, RFS, NRM, MMF, Weill Cornell Medicine, Risk, Thiotepa, Graft-versus-host disease, Bone marrow, Society, BFT, MDS, CNI, Patient, Hematopoietic stem cell transplantation, NewYork-Presbyterian Hospital, Survival, Transplant, Acute myeloid leukemia, Weill Cornell Medical Center, Cancer, Busulfan, Pharmaceutical industry

In the first of two oral presentations, findings from a retrospective analysis compared historical outcomes between Orca-T and a standard of care allogeneic stem cell transplant (alloHSCT) plus post-transplant cyclophosphamide (PTCy)-based graft versus host disease (GvHD) prophylaxis in patients with hematologic malignancies receiving myeloablative conditioning (MAC).

Key Points: 
  • In the first of two oral presentations, findings from a retrospective analysis compared historical outcomes between Orca-T and a standard of care allogeneic stem cell transplant (alloHSCT) plus post-transplant cyclophosphamide (PTCy)-based graft versus host disease (GvHD) prophylaxis in patients with hematologic malignancies receiving myeloablative conditioning (MAC).
  • Within the non-randomized cohorts of varying conditioning regimens and disease types, Orca-T demonstrated favorable results across clinical outcomes including relapse-free survival (RFS), non-relapse mortality (NRM) and overall survival (OS).
  • The analysis included patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) who had a median follow-up time of 15 months and 12 months in the Orca-T and PTCy cohorts, respectively.
  • The outcomes at 12 months are summarized in the table below:

Orca Bio Presents Positive Data Demonstrating the Potential for Orca-T and Orca-Q to Expand Treatment to Additional Patient Groups at the 65th ASH Annual Meeting

Retrieved on: 
Saturday, December 9, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, MAC, Thiotepa, NRM, Safety, Toxicity, CTCAE, Incidence, ASH, Acute myeloid leukemia, Acute leukemia, Syndrome, Risk, University, Mortality, Patient, Busulfan, Infection, BFT, RFS, MDS, Graft-versus-host disease, HSCT, Cancer, Trial of the century, CML, Toxic epidermal necrolysis, Bone marrow, AML, RIC, MD Anderson Cancer Center, Physician, OS, Quality of life, Society, ALL, Face, Pharmaceutical industry, Vaccine, Dentistry, Medical imaging

The results presented at the 65th American Society of Hematology (ASH) Annual Meeting showed promising data with the use of Orca Bio’s cell therapies across several patient groups where there is significant unmet medical need.

Key Points: 
  • The results presented at the 65th American Society of Hematology (ASH) Annual Meeting showed promising data with the use of Orca Bio’s cell therapies across several patient groups where there is significant unmet medical need.
  • Results highlighted in an oral presentation showed Orca-T’s ability to deliver similar outcomes in older patients undergoing myeloablative conditioning (MAC) as younger patients.
  • In this subgroup from the ongoing multi-center Phase 1b clinical trial, Orca-T demonstrated promising results in this patient population (n=16).
  • The estimated incidence of CTCAE grade 2 and greater than grade 3 infections at one year were 9% and 15%, respectively.

Akari Therapeutics Announces Presentation of a Case Study from Phase 3 Part A Clinical Trial of Nomacopan in Pediatric HSCT-TMA as a Late-Breaker at The Transplantation & Cellular Therapy Tandem Meetings

Retrieved on: 
Tuesday, February 21, 2023
DSM-IV codes, Royal Manchester Children's Hospital, AML, PRES, CH50, Thrombocytopenia, Hope, HSCT, Viremia, LTB4, Diagnosis, Leukotriene B4, NHS foundation trust, Thrombotic microangiopathy, Maintenance, GVHD, Division, Hematopoietic stem cell transplantation, Patient, Hospital, Clinical trial, Inflammation, Center for International Blood and Marrow Transplant Research, TMA, University, Research, Therapy, Male, Hypertension, TCA, Death, University of Manchester, Thiotepa, End organ damage, Manchester University NHS Foundation Trust, Cytomegalovirus, System, Transplant, Society, Syndrome, Hot game, Rosenthal, CMV, Pharmaceutical industry, Dentistry, Pediatrics

The case study, Clinical Response to Nomacopan in the Pediatric HSCT-TMA Setting, was presented on Thursday February 16, at 5:45 pm ET at the Transplantation & Cellular Therapy Tandem Meetings in Orlando, Florida.

Key Points: 
  • The case study, Clinical Response to Nomacopan in the Pediatric HSCT-TMA Setting, was presented on Thursday February 16, at 5:45 pm ET at the Transplantation & Cellular Therapy Tandem Meetings in Orlando, Florida.
  • The patient received 7 granulocyte infusions peri-transplant as part of an experimental protocol to augment the graft-versus-leukemia effect.
  • His immediate post-transplant course was complicated by engraftment syndrome, acute gut graft-versus-host disease (GVHD) grade 3 and cytomegalovirus (CMV) viraemia.
  • Nomacopan was stopped for 3 days and restarted after the diagnosis was deemed to be unrelated to nomacopan treatment.

Orca Bio Presents Positive Data Reinforcing Clinical Profile of Orca-T and Orca-Q at 2023 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR

Retrieved on: 
Thursday, February 16, 2023
Biotechnology, Health, Oncology, BFT, Bone marrow, AML, MD Anderson Cancer Center, Rated R, Abstract, University, ASH, Busulfan, Patient, Infection, Acute leukemia, HLA, Mortality, Risk, Toxic epidermal necrolysis, Graft-versus-host disease, ALL, Survival, MDS, Thiotepa, Acute myeloid leukemia, Society, Transplant, GRFS, Bio, Syndrome, Cancer, Pharmaceutical industry, Dentistry

Outcomes with Orca-T appeared to be further enhanced in patients who received a conditioning regimen of busulfan, fludarabine and thiotepa (BFT).

Key Points: 
  • Outcomes with Orca-T appeared to be further enhanced in patients who received a conditioning regimen of busulfan, fludarabine and thiotepa (BFT).
  • These data were previously presented at the 64th American Society of Hematology (ASH) Annual Meeting in December 2022.
  • In a second oral presentation, new data highlighted how expanding the donor pool may help address disparities in access to transplant.
  • While this early data is encouraging, more studies of Orca-T in this patient population are ongoing and will provide additional clinical data in this setting.

Orca Bio Presents Data Demonstrating its Lead Investigational High-Precision Cell Therapy Orca-T Significantly Improved Relapse-Free Survival at 64th ASH Annual Meeting

Retrieved on: 
Saturday, December 10, 2022
Oncology, Health, Clinical Trials, Research, Science, Biotechnology, Busulfan, Physician, Microdeletion syndrome, Food, Center for International Blood and Marrow Transplant Research, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Thiotepa, Society, Patient, Cancer, RFS, ALL, Degenerative disease, Overalls, Acute leukemia, Quality of life, Bio, Survival, AML, BFT, Lymphatic system, Mortality, MDS, Acute myeloid leukemia, GRFS, Toxic epidermal necrolysis, Blood, ASH, Pharmaceutical industry, Vaccine

Orca Bio, a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer, genetic blood disorders and autoimmune diseases, today presented updated positive clinical data on its lead investigational cell therapy, Orca-T, during an oral presentation at the 64th American Society of Hematology (ASH) Annual Meeting.

Key Points: 
  • Orca Bio, a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer, genetic blood disorders and autoimmune diseases, today presented updated positive clinical data on its lead investigational cell therapy, Orca-T, during an oral presentation at the 64th American Society of Hematology (ASH) Annual Meeting.
  • These new data continue to reinforce the potential of this high-precision cell therapy to become a better treatment option for patients and transplant physicians.
  • Orca Bio is a late-stage biotechnology company developing purified, high-precision cell therapies for the treatment of cancer, autoimmune diseases and genetic blood disorders.
  • At Orca Bio, we hope to not only replace patients' blood and immune systems with healthy ones, but restore their quality of life.

Fresenius Kabi Announces U.S. Availability of Cancer Therapeutic Thiotepa

Retrieved on: 
Friday, July 29, 2022
Biotechnology, Pharmaceutical, Oncology, General Health, Health, FDA, Medical Devices, Health Technology, Fetus, Infection, Skin, Diarrhea, Toxicity, Mucositis, Urinary bladder, Industry, Ovary, Bleeding, Cytomegalovirus, CEO, Thiotepa, USP, Incidence, Hematuria, Risk, Multimedia, Kidney, Pregnancy, Rash, Injection, FDA, Patient, LinkedIn, Life, Hypersensitivity, Adenocarcinoma, Fresenius (company), Thyroid cancer, Thrombocytopenia, Liver, LLC, Breast, Bone marrow suppression, Anemia, Neutropenia, Vaccine, Medical imaging, Pharmaceutical industry, Medical device

Fresenius Kabi announced today it has introduced Thiotepa for Injection, USP, in the United States.

Key Points: 
  • Fresenius Kabi announced today it has introduced Thiotepa for Injection, USP, in the United States.
  • View the full release here: https://www.businesswire.com/news/home/20220729005063/en/
    Fresenius Kabi Thiotepa for Injection, USP is a generic equivalent to Tepadina (Photo: Business Wire)
    Fresenius Kabi Thiotepa for Injection, USP is available immediately in 100 mg single-dose vials.
  • We are pleased to add Thiotepa for Injection, USP to our portfolio of generic oncology medicines, said John Ducker, president and CEO of Fresenius Kabi USA.
  • To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-8005517176, option 5, or FDA at 1800FDA1088 or www.fda.gov/medwatch.com .

LIPAC Oncology Announces Presentation of Data from Phase 1/2a Study of LiPax in Patients with Highly Recurrent Bladder Cancer

Retrieved on: 
Monday, May 18, 2020
Organic compounds, Clinical medicine, Medicine, RTT, Taxanes, Bristol-Myers Squibb, Paclitaxel, Bladder cancer, Transurethral resection of the prostate, Mark Soloway, Thiotepa

Trial results showed 100% (6/6) of patients treated with Transurethral Resection of Bladder Tumor (TURBT) and LiPax achieved a complete response three, six and nine months after the start of therapy.

Key Points: 
  • Trial results showed 100% (6/6) of patients treated with Transurethral Resection of Bladder Tumor (TURBT) and LiPax achieved a complete response three, six and nine months after the start of therapy.
  • The 12-month recurrence free survival rate was 85% (5/6) and 100% (3/3) for all patients that reached the 18-month mark.
  • LiPax (paclitaxel) for intravesical instillation is an investigational drug formulation of paclitaxel in Phase 2 development for the treatment of NMIBC.
  • LIPAC Oncology is a pharmaceutical company utilizing the proprietary proliposomal delivery system to enhance and reformulate proven cancer drugs into more effective treatments.

Novadoz Pharmaceuticals Increases Presence in the Generic Oncology Market with an FDA Approval of Thiotepa 15mg &100mg Vials for Injection

Retrieved on: 
Friday, March 6, 2020
Health, Pharmaceuticals policy, Articles, Cancer treatments, Orphan drugs, Aziridines, Thiotepa, Pharmaceutical industry in China, Generic drug

PISCATAWAY, N.J., March 6, 2020 /PRNewswire/ -- Novadoz Pharmaceuticals, the U.S based sales & marketing affiliate for MSN Labs, based in Hyderabad India, received FDA approval for their generic version of Thiotepa 15mg and 100mg vials for injection.

Key Points: 
  • PISCATAWAY, N.J., March 6, 2020 /PRNewswire/ -- Novadoz Pharmaceuticals, the U.S based sales & marketing affiliate for MSN Labs, based in Hyderabad India, received FDA approval for their generic version of Thiotepa 15mg and 100mg vials for injection.
  • The combined Thiotepa brand and generic sales are trending over $36.5mil during the previous 12 months according to recent published sales data.
  • Thiotepa for injection is indicated for treatment of adenocarcinoma of the breast or ovary.The recommended dose of Thiotepa for injection for treatment of adenocarcinoma of the breast or ovary is 0.3 to 0.4 mg/kg intravenously.
  • Seshu Akula, Novadoz President North America Generics, quotes, "MSN's approval for generic Thiotepa 15mg & 100mg vials for injection, increases the company's basket of specialty injectable products, moving forward our commitment to the generic oncology space.

Accord and ADIENNE Enter into Exclusive Distribution Agreement for TEPADINA®

Retrieved on: 
Monday, November 18, 2019
Cancer, Medicine, Clinical medicine, Cancer treatments, Aziridines, Thiotepa, Oncology, Chemotherapy, Freeze-drying, ENH

LONDON and LUGANO, Switzerland, Nov. 18, 2019 /PRNewswire/ --Accord Healthcare Limited ("Accord") and ADIENNE Pharma & Biotech S.A. ("ADIENNE") have entered into an exclusive licencing and distribution agreement for the commercialisation of TEPADINA(thiotepa) 15mg and 100mg lyophilized powder for injections.

Key Points: 
  • LONDON and LUGANO, Switzerland, Nov. 18, 2019 /PRNewswire/ --Accord Healthcare Limited ("Accord") and ADIENNE Pharma & Biotech S.A. ("ADIENNE") have entered into an exclusive licencing and distribution agreement for the commercialisation of TEPADINA(thiotepa) 15mg and 100mg lyophilized powder for injections.
  • ADIENNE is also working on a new delivery presentations for TEPADINA (thiotepa) and other oncology and cytotoxic drugs to improve and enhance the healthcare professional and patient experience.
  • The new delivery presentations for TEPADINA will be commercialized by Accord in Europe and India.
  • Accord will begin selling TEPADINA across select markets in the European region such as Italy, Spain, UK, Ireland, Benelux and Portugal.