RTT

Blue Earth Diagnostics Highlights Presentations on Axumin® (Fluciclovine F 18) at Upcoming 2021 ASCO Genitourinary Cancers Symposium (ASCO GU)

Retrieved on: 
Monday, February 8, 2021

Blue Earth Diagnostics invites participants at the ASCO 2021 Genitourinary Cancers Symposium (ASCO GU) to attend the presentations above and to visit Blue Earth Diagnostics commercial exhibit in the Virtual Exhibit hall.

Key Points: 
  • Blue Earth Diagnostics invites participants at the ASCO 2021 Genitourinary Cancers Symposium (ASCO GU) to attend the presentations above and to visit Blue Earth Diagnostics commercial exhibit in the Virtual Exhibit hall.
  • A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence.
  • Formed in 2014, Blue Earth Diagnostics is led by proven experts in nuclear medicine, who have expanded and advanced its robust oncology portfolio.
  • 18F-fluciclovine has a broad range of other potential applications in cancer imaging and Blue Earth Diagnostics is investigating the molecule for other cancers, including in neuro-oncology.

Lannett Begins Marketing Chlorpromazine Hydrochloride Tablets

Retrieved on: 
Monday, February 8, 2021

PHILADELPHIA, Feb. 8, 2021 /PRNewswire/ --Lannett Company, Inc. (NYSE: LCI) today announced that it has begun marketing Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 25 mg, 50 mg, 100 mg and 200 mg.

Key Points: 
  • PHILADELPHIA, Feb. 8, 2021 /PRNewswire/ --Lannett Company, Inc. (NYSE: LCI) today announced that it has begun marketing Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 25 mg, 50 mg, 100 mg and 200 mg.
  • "Chlorpromazine Hydrochloride Tablets, an internally developed product,is used to treat psychotic disorders such as schizophrenia or manic-depression in adults," said Tim Crew, chief executive officer of Lannett.
  • "We expect Chlorpromazine Hydrochloride Tablets will be a solid addition to our product offering, with margins above our company average."
  • Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 25 mg, 50 mg, 100 mg and 200 mg is the therapeutic equivalent of the reference listed drug Thorazine Tablets10 mg, 25 mg, 50 mg, 100 mg and 200 mg of GlaxoSmithKline.

DGAP-News: MagForce AG: MagForce USA, Inc. Announces Completion of Patient Treatment in Stage 2a of Pivotal U.S. Single-Arm Study for the Focal Ablation of Intermediate Risk Prostate Cancer with the NanoTherm Therapy System

Retrieved on: 
Monday, February 8, 2021

Announces Completion of Patient Treatment in Stage 2a of Pivotal U.S. Single-Arm Study for the Focal Ablation of Intermediate Risk Prostate Cancer with the NanoTherm Therapy System

Key Points: 
  • Announces Completion of Patient Treatment in Stage 2a of Pivotal U.S. Single-Arm Study for the Focal Ablation of Intermediate Risk Prostate Cancer with the NanoTherm Therapy System
    The issuer is solely responsible for the content of this announcement.
  • Upon FDA approval, this streamlined procedure will allow patient treatment to be completed within a single day.
  • Stage 2b will focus on offering a treatment alternative to immediate risk prostrate cancer patients to that of definitive therapy.
  • Clearly, early diagnosis and MagForce's focal therapy have a strong chance to reduce the death rate for prostate cancer.

AC Immune Initiates Clinical Study of First-in-class Diagnostic for Parkinson’s Disease

Retrieved on: 
Monday, February 8, 2021

AC Immune expects to report the results of the study in Q3 2021.

Key Points: 
  • AC Immune expects to report the results of the study in Q3 2021.
  • The clinical study is supported by the Michael J.
  • Fox Foundation for Parkinsons Research (MJFF), building on The Foundations significant funding of AC Immunes program since 2015.
  • AC Immune SA is a Nasdaq-listed clinical-stage biopharmaceutical company, which aims to become a global leader in precision medicine for neurodegenerative diseases.

Seneca Therapeutics Expands Product Pipeline Adding Six New SVV-001 Armed Constructs Targeting TEM 8 Expression

Retrieved on: 
Monday, February 8, 2021

Each of these new gene therapy technologies uses SVV to exclusively target cancer cells with TEM 8 expression.

Key Points: 
  • Each of these new gene therapy technologies uses SVV to exclusively target cancer cells with TEM 8 expression.
  • Normal cells lack significant expression of TEM 8 and are therefore not infected by SVV-001, and so the armed transgene will not express in normal cells.
  • Studies in multiple human tumor types indicates TEM 8 expression is an adverse indicator of long-term survival and is associated with cancer metastasis.
  • The SVV-001 Armed Construct for Neo-antigens program plans to use patient specific neo-antigens to take advantage of the rapid two-week development cycle for SVV-001 Armed Constructs.

New Data Demonstrate Long-Term Benefit of IMBRUVICA® (ibrutinib) as First-Line Treatment for High-Risk Chronic Lymphocytic Leukaemia

Retrieved on: 
Sunday, December 6, 2020

Janssen Biotech, Inc.; Janssen-Cilag Ltd., Middle East; and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Key Points: 
  • Janssen Biotech, Inc.; Janssen-Cilag Ltd., Middle East; and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
  • Real-world prognostic biomarker testing, treatment patterns and dosing among 1461 patients (pts) with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) from the informCLL prospective observational registry.
  • Ibrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab in first-line treatment of chronic lymphocytic leukaemia (iLLUMINATE): a multicentre, randomised, open-label, phase 3 trial.
  • Chronic lymphocytic leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.

Combined Data from Multiple Phase 3 Studies of IMBRUVICA® (ibrutinib) Show Efficacy and Safety in High-Risk, Previously Untreated Chronic Lymphocytic Leukemia (CLL) and Real-World Data Indicating Low Biomarker Testing Rates for These Patients

Retrieved on: 
Sunday, December 6, 2020

In RESONATE-2 (NCT01722487), patients aged 65 years without del(17p) were randomized to single-agent IMBRUVICA or chlorambucil.

Key Points: 
  • In RESONATE-2 (NCT01722487), patients aged 65 years without del(17p) were randomized to single-agent IMBRUVICA or chlorambucil.
  • In iLLUMINATE (NCT02264574), patients aged 65 years, or
  • The integrated analysis included 498 patients treated with first-line IMBRUVICA -based or chlorambucil-based therapy (n=249 each) with a median follow-up of 49.1 months.
  • Eighty-nine patients with TP53 aberrations receiving first-line IMBRUVICA treatment were included in this pooled analysis.

MacroGenics Presents Flotetuzumab Data in Patients with Refractory Acute Myeloid Leukemia at the 2020 ASH Annual Meeting

Retrieved on: 
Sunday, December 6, 2020

Within the PIF/ER6 population, five of ten patients with TP53MUT AML achieved CR/CRh/CRi responses, three of whom went on to receive HSCT.

Key Points: 
  • Within the PIF/ER6 population, five of ten patients with TP53MUT AML achieved CR/CRh/CRi responses, three of whom went on to receive HSCT.
  • More detailed flotetuzumab clinical data in the TP53MUT AML population is available via a separate poster presentation at ASH (see TP53 Abnormalities Correlate with Immune Infiltration and Associate with Response to Flotetuzumab Immunotherapy in Acute Myeloid Leukemia, Session 617).
  • The most common treatment-related adverse event (TRAE) was infusion-related reaction/cytokine release syndrome (IRR/CRS), which occurred in all patients.
  • In addition to the above data provided in an oral presentation, five additional presentations related to flotetuzumab and AML have or will be presented at ASH.

Magrolimab Demonstrates Clinical Responses in Ongoing Phase 1b Trial of Previously Untreated Acute Myeloid Leukemia Patients

Retrieved on: 
Sunday, December 6, 2020

Magrolimab is an investigational, potential first-in-class, anti-CD47 monoclonal antibody being studied in previously untreated acute myeloid leukemia (AML) patients who are ineligible for intensive chemotherapy, including patients with TP53-mutant AML.

Key Points: 
  • Magrolimab is an investigational, potential first-in-class, anti-CD47 monoclonal antibody being studied in previously untreated acute myeloid leukemia (AML) patients who are ineligible for intensive chemotherapy, including patients with TP53-mutant AML.
  • In the study, 64 patients were treated with magrolimab plus azacitidine, including 47 patients with the TP53 mutation, a treatment-refractory and poor-prognosis population.
  • For patients with the TP53 mutation, 69% (n=20/29) achieved a response, 45% (n=13/29) achieved a CR and 14% (n=4/29) achieved a CRi.
  • All patients in the trial received a magrolimab 1 mg/kg priming dose, coupled with intrapatient dose escalation, to mitigate on-target anemia.

Fate Therapeutics Presents Patient Case Study Demonstrating Clinical Activity of FT596 in Refractory Diffuse Large B-cell Lymphoma

Retrieved on: 
Sunday, December 6, 2020

The case study described a heavily pre-treated patient with diffuse large B-cell lymphoma (DLBCL) who achieved a partial response following administration of a single-dose treatment cycle of FT596 as a monotherapy in the first dose cohort of 30 million cells.

Key Points: 
  • The case study described a heavily pre-treated patient with diffuse large B-cell lymphoma (DLBCL) who achieved a partial response following administration of a single-dose treatment cycle of FT596 as a monotherapy in the first dose cohort of 30 million cells.
  • Approximately 3.5 months from last prior therapy, the patient enrolled into the first dose cohort of FT596 as a monotherapy at 30 million cells.
  • The patient underwent fludarabine and cyclophosphamide lympho-conditioning and was administered a single dose of FT596 as a monotherapy at 30 million cells (Study Day 1).
  • Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders.