Bone marrow

Australian biotech company Starpharma announces positive interim results from the prostate cancer cohort in its ongoing phase 2 trial of DEP® cabazitaxel

Friday, November 26, 2021 - 9:43am

DEP cabazitaxel is a patented, detergent (polysorbate-80[1])-free, nanoparticle version of the conventional cancer drug, Jevtana - a leading oncology agent used to treat advanced prostate cancer.

Key Points: 
  • DEP cabazitaxel is a patented, detergent (polysorbate-80[1])-free, nanoparticle version of the conventional cancer drug, Jevtana - a leading oncology agent used to treat advanced prostate cancer.
  • Starpharma 's interim results in Stage IV prostate cancer show that one or more efficacy signals[2] were observed in 100% of patients assessed following DEP cabazitaxel treatment.
  • DEP cabazitaxel is one of Starpharma's three internal clinical-stage DEP assets, alongside DEP docetaxel and DEP irinotecan, which Starpharma intends to licence following phase 2.
  • [2]Efficacy in the prostate cancer cohort in the trial was assessed referencing the applicable aspects of the internationally recognised Prostate Cancer Working Group (PCWG3) guidelines.

Apollomics Inc. Doses First Patient in Phase 3 Clinical Trial in China of GlycoMimetics’ Uproleselan for the Treatment of AML

Tuesday, November 23, 2021 - 9:30pm

GlycoMimetics, Inc. (Nasdaq: GLYC) announced today that Apollomics has dosed the first patient in China in a Phase 3 clinical trial of APL-106 (uproleselan injection) for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML).

Key Points: 
  • GlycoMimetics, Inc. (Nasdaq: GLYC) announced today that Apollomics has dosed the first patient in China in a Phase 3 clinical trial of APL-106 (uproleselan injection) for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML).
  • Apollomics Phase 3 trial with APL-106 is part of the overall development program for Apollomics in China that also includes an ongoing Phase 1 pharmacokinetics (PK) and tolerability study.
  • The trial will enroll approximately 140 adult patients with primary refractory AML or relapsed AML (first or second untreated relapse) and eligible to receive induction chemotherapy.
  • Apollomics expects to conduct this study at approximately 20 blood cancer clinical research centers across China.

Cell Therapy Markets, 2030 - ResearchAndMarkets.com

Tuesday, November 23, 2021 - 3:29pm

This report describes and evaluates cell therapy technologies and methods, which have already started to play an important role in the practice of medicine.

Key Points: 
  • This report describes and evaluates cell therapy technologies and methods, which have already started to play an important role in the practice of medicine.
  • Cell therapy is bound to become a part of medical practice.
  • Cell therapy technologies overlap with those of gene therapy, cancer vaccines, drug delivery, tissue engineering, and regenerative medicine.
  • Safety is an essential consideration of any new therapy and regulations for cell therapy are those for biological preparations.

$3.94 Bn Hematology Analyzer Markets - Global Opportunity Analysis and Industry Forecast, 2021-2030. - ResearchAndMarkets.com

Tuesday, November 23, 2021 - 12:20pm

The "Hematology Analyzer Market by Product & Service, Type and End User: Global Opportunity Analysis and Industry Forecast, 2021-2030."

Key Points: 
  • The "Hematology Analyzer Market by Product & Service, Type and End User: Global Opportunity Analysis and Industry Forecast, 2021-2030."
  • The global hematology analyzer market was valued at $1,962.40 million in 2020 and is projected to reach $3,941.10 million by 2030 registering a CAGR of 7.30% from 2021 to 2030.
  • In addition, technological advancements in hematology analyzers, and growth in demand for automated hematology analyzer coupled with rising preference towards high sensitivity hematology analyzer further boost the growth of the hematology analyzer market.
  • In contrast, growth opportunities in emerging economics expected to offer lucrative growth opportunities for players in the hematology analyzer market.

GlycoMimetics Appoints Regulatory Veteran Lisa DeLuca as Vice President, Regulatory Affairs

Monday, November 22, 2021 - 9:15pm

GlycoMimetics, Inc. (Nasdaq: GLYC) announced today that Lisa DeLuca, Ph.D., has joined its executive leadership team as Vice President, Regulatory Affairs.

Key Points: 
  • GlycoMimetics, Inc. (Nasdaq: GLYC) announced today that Lisa DeLuca, Ph.D., has joined its executive leadership team as Vice President, Regulatory Affairs.
  • Dr. DeLuca is a veteran regulatory expert who has previously led the strategy-formation and execution of multiple global NDA submissions and product registrations.
  • Most recently she was the head of regulatory affairs at Nuvation Bio and a member of its executive leadership team.
  • Lisa is a seasoned executive who brings to GlycoMimetics significant expertise in regulatory strategy and agency interactions.

Apollomics Inc. Doses First Patient in Phase 3 Clinical Trial with APL-106 (Uproleselan Injection) in Chinese Patients with Relapsed/Refractory Acute Myeloid Leukemia

Monday, November 22, 2021 - 1:40am

"AML is a highly aggressive hematological cancer, and the prognosis of patients with relapsed or refractory disease is extremely poor.

Key Points: 
  • "AML is a highly aggressive hematological cancer, and the prognosis of patients with relapsed or refractory disease is extremely poor.
  • This combined treatment approach could have a meaningful impact on the lives of patients living with relapsed or refractory AML."
  • The Phase 3 trial with APL-106 is part of the overall development program for Apollomics in China that also includes an ongoing Phase 1 pharmacokinetics (PK) and tolerability study.
  • The U.S. Food and Drug Administration granted Breakthrough Therapy Designation to uproleselan for the treatment of adults with relapsed or refractory acute myeloid leukemia.

Apollomics Inc. Doses First Patient in Phase 3 Clinical Trial with APL-106 (Uproleselan Injection) in Chinese Patients with Relapsed/Refractory Acute Myeloid Leukemia

Monday, November 22, 2021 - 12:10pm

AML is a highly aggressive hematological cancer, and the prognosis of patients with relapsed or refractory disease is extremely poor.

Key Points: 
  • AML is a highly aggressive hematological cancer, and the prognosis of patients with relapsed or refractory disease is extremely poor.
  • This combined treatment approach could have a meaningful impact on the lives of patients living with relapsed or refractory AML.
  • The Phase 3 trial with APL-106 is part of the overall development program for Apollomics in China that also includes an ongoing Phase 1 pharmacokinetics (PK) and tolerability study.
  • The U.S. Food and Drug Administration granted Breakthrough Therapy Designation to uproleselan for the treatment of adults with relapsed or refractory acute myeloid leukemia.

Bionano Genomics Announces Peer-Reviewed Publication from Johns Hopkins University Outlining a Stepwise Approach to the Adoption of Optical Genome Mapping for Cancer Analysis

Monday, November 22, 2021 - 1:00pm

Sensitivity compared to CMA was 96% (22/23 CNVs detected) excluding copy neutral loss of heterozygosity calls.

Key Points: 
  • Sensitivity compared to CMA was 96% (22/23 CNVs detected) excluding copy neutral loss of heterozygosity calls.
  • OGM was also used in the study to provide high resolution analysis of subjects with complex karyotypes exhibiting chromothripsis.
  • Bionano is a provider of genome analysis solutions that can enable researchers and clinicians to reveal answers to challenging questions in biology and medicine.
  • The Companys mission is to transform the way the world sees the genome through OGM solutions, diagnostic services and software.

BioRestorative Therapies Enters into Letter of Intent with PRC Clinical

Friday, November 19, 2021 - 11:00am

MELVILLE, N.Y., Nov. 19, 2021 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (the “Company" or “BioRestorative”) (NASDAQ:BRTX), a life sciences company focused on adult stem cell-based therapies, today announced that it has entered into a letter of intent with PRC Clinical, a CRO specializing in clinical trial management, with regard to PRC Clinical providing startup clinical project management activities for the Company’s BRTX-100 Phase 2 clinical trial to treat chronic lumbar disc disease.

Key Points: 
  • MELVILLE, N.Y., Nov. 19, 2021 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (the Company" or BioRestorative) (NASDAQ: BRTX ), a life sciences company focused on adult stem cell-based therapies, today announced that it has entered into a letter of intent with PRC Clinical, a CRO specializing in clinical trial management, with regard to PRC Clinical providing startup clinical project management activities for the Companys BRTX-100 Phase 2 clinical trial to treat chronic lumbar disc disease.
  • We are pleasedto announce that we have entered into a letter of intent for PRC Clinical to provide startup activities for our Phase 2 study.
  • PRC has extensive experience and expertise in managing clinical studies in the stem cell and regenerative medicine space.
  • We are committed to supporting BioRestoratives development of BRTX-100 and its clinical application, said Curtis Head, CEO of PRC Clinical.

U.S. Food and Drug Administration Approves Longeveron’s Lomecel-B for Rare Pediatric Disease Designation to Treat Life-Threatening Infant Heart Condition

Thursday, November 18, 2021 - 1:00pm

Lomecel-B, an investigational allogeneic, bone marrow-derived medicinal signaling cell (MSC) product, is currently being evaluated in a Phase 2 trial.

Key Points: 
  • Lomecel-B, an investigational allogeneic, bone marrow-derived medicinal signaling cell (MSC) product, is currently being evaluated in a Phase 2 trial.
  • We are encouraged by our Phase 1 clinical data, and the progress being made in the ongoing Phase 2 trial.
  • Lomecel-B represents a unique cell therapy approach that could potentially be administered at the same time as surgery in these critically impacted infants.
  • Longeveron recently reported clinical results from its safety-focused Phase I clinical study of Lomecel-B in HLHS patients.