7+3

Arbutus Reports First Quarter 2021 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, May 5, 2021
Antiviral drugs, Medical specialties, Virology, Sarbecovirus, Antigens, HBsAg, Hepatitis B virus, Coronavirus, Coronavir, Severe acute respiratory syndrome coronavirus 2, 7+3, Medicine

This progress reflects our objective to develop a combination regimen that provides a functional cure for people living with HBV.

Key Points: 
  • This progress reflects our objective to develop a combination regimen that provides a functional cure for people living with HBV.
  • We were also gratified to establish an innovative collaboration with X-Chem, Inc. and Proteros biostructures GmbH.
  • The objective of this alliance is to expedite our efforts to discover an effective oral antiviral therapy against coronaviruses including SARS-CoV-2 targeting the main protease.\xe2\x80\x9d\nMr.
  • Efficacy results to date suggest that repeat dosing using the 60 mg dose every 4 weeks resulted in a continuous and robust mean HBsAg decline at week 24 (-1.84 log10 IU/mL, N=7).

Biosight to Present Updated Clinical Data from Ongoing Phase 2b Study of Aspacytarabine (BST-236) at the 2021 ASCO Annual Meeting

Retrieved on: 
Wednesday, April 28, 2021
Cancer treatments, Clinical medicine, Cancer, Arabinosides, Cytarabine, Nucleosides, 7+3, IA, Antibody-drug conjugates

It is composed of cytarabine covalently bound to asparagine, acting as a pro-drug of cytarabine.

Key Points: 
  • It is composed of cytarabine covalently bound to asparagine, acting as a pro-drug of cytarabine.
  • Due to its unique pharmacokinetics and metabolism, aspacytarabine enables high-dose therapy with lower systemic exposure to free cytarabine and relative sparing of normal tissues.
  • For more information regarding the Phase 2b clinical study of BST-236, please visit www.clinicaltrials.gov .\nBiosight is a private Phase 2 clinical stage biotech company developing innovative therapeutics for hematological malignancies and disorders.
  • Additional Phase 2 studies to be initiated in 2021 include a study in relapsed/refractory AML and MDS, including a study in collaboration with the European cooperative group, GFM.

Trillium Therapeutics Provides Data Update, Announces Phase 1b/2 Program Priorities Across Hematologic Malignancies and Solid Tumors, and Reports Governance Changes

Retrieved on: 
Wednesday, April 28, 2021
Health sciences, Life sciences, Pharmacokinetics, Pharmacy, Dat, Ade, 7+3, Dose, Ice, Dosing, Health

In parallel, we are continuing to evaluate less frequent dosing regimens than our current weekly dosing.

Key Points: 
  • In parallel, we are continuing to evaluate less frequent dosing regimens than our current weekly dosing.
  • \xe2\x80\x9cBob has played a pivotal role in transitioning the CEO leadership in 2019, and positioning the company for our subsequent transformation program in 2020.
  • Trillium would not be where it is today without Bob\xe2\x80\x99s leadership, hands-on contributions and personal sacrifices.
  • Pharmacokinetic data demonstrated dose-proportional increases in drug exposure between 8 and 18 mg/kg, and support evaluating less frequent dosing.

JCRI-ABTS and USMI Successfully Use Canady Helios™ Cold Plasma in Combination with FOLFIRINOX for the Treatment of Cholangiocarcinoma

Retrieved on: 
Wednesday, April 28, 2021
Research, Medical devices, FDA, Clinical trials, Other Health, Biotechnology, General Health, Health, Science, Oncology, Cancer treatments, Cancer, Clinical medicine, Chemotherapy regimens, FOLFIRINOX, FOLFIRI, Chemotherapy, 7+3, JCRI-ABTS, US Medical Innovations, JCRI-ABTS, US MEDICAL INNOVATIONS

Current treatments include systemic chemotherapeutic regimens such as FOLFIRINOX.

Key Points: 
  • Current treatments include systemic chemotherapeutic regimens such as FOLFIRINOX.
  • A limitation of this chemotherapy regimen is its toxicity and adverse events.
  • There exists a need for therapies to alleviate the toxicity of a FOLFIRINOX regimen while enhancing, or not altering, its anticancer properties.\nAccording to Jerome Canady, MD, and Chief Science Officer, \xe2\x80\x9cOur analysis of cell viability, proliferation, and the cell cycle demonstrated that CHCAP in combination with FOLFIRINOX is more effective than either treatment alone.
  • USMI is dedicated to expanding the boundaries of plasma medicine by pioneering new technologies for the development of state-of-the-art medical devices that advance patient outcomes and improve human lives.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210428005762/en/\n'

Bristol Myers Squibb Receives Positive CHMP Opinion for Onureg® (azacitidine tablets; CC-486) as Frontline Oral Maintenance Therapy for Adults with Acute Myeloid Leukemia in First Remission

Retrieved on: 
Friday, April 23, 2021
Other Health, Research, General Health, Pharmaceutical, Oncology, Infectious diseases, Clinical trials, Science, Biotechnology, FDA, Other Science, Health, Medical specialties, Clinical medicine, Cancer, Orphan drugs, Lactams, Azacitidine, Nucleosides, Triazines, Acute myeloid leukemia, Febrile neutropenia, 7+3, Neutropenia

A subgroup analysis showed consistency in the OS benefit for patients in either CR or CRi.

Key Points: 
  • A subgroup analysis showed consistency in the OS benefit for patients in either CR or CRi.
  • Serious adverse reactions in \xe2\x89\xa52% of patients who received Onureg included pneumonia (8%) and febrile neutropenia (7%).
  • One fatal adverse reaction (sepsis) occurred in a patient who received Onureg.
  • Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission (QUAZAR AML-001).

Global Acute Myeloid Leukemia (AML) Disease Analysis Report 2021 - ResearchAndMarkets.com

Retrieved on: 
Friday, April 9, 2021
Health, General Health, Acute myeloid leukemia, Leukemia, Devimistat, 7+3, Clinical medicine, Oncology, Cancer, Antibody-drug conjugates, Entospletinib, Lintuzumab

The "Disease Analysis: Acute Myeloid Leukemia (AML)" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Disease Analysis: Acute Myeloid Leukemia (AML)" report has been added to ResearchAndMarkets.com's offering.
  • "Acute" means that the leukemia may progress rapidly - AML generally spreads quickly to the bloodstream and can then spread to other parts of the body including the lymph nodes, spleen, central nervous system, and testicles.
  • Key upcoming catalysts for 2021 include topline results from Phase III trials for devimistat, Iomab-B, uproleselan, and Zeltherva, and a possible NDA submission for FT-2102.
  • AML drugs, on average, take 10.8 years from Phase I to approval, compared to 9.6 years in the overall oncology space.

Phase 1/2 Trial Initiated for Daiichi Sankyo’s Menin Inhibitor DS-1594 in Patients with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia

Retrieved on: 
Wednesday, April 7, 2021
Biotechnology, Pharmaceutical, Health, Oncology, Cancer treatments, Cancer, Companies, Acute myeloid leukemia, Daiichi Sankyo, Acute lymphoblastic leukemia, 7+3, Antibody-drug conjugates, Antineoplastic drugs, Orphan drugs, Camidanlumab tesirine, Antibody-drug conjugate, the Study, Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, MLL, NPM1 and Menin, DS-1594, Daiichi Sankyo

Daiichi Sankyo Company, Limited (hereafter Daiichi Sankyo) today announced the first patient has been dosed in the first-in-human phase 1/2 study of DS-1594, a selective small-molecule menin inhibitor, in adults with relapsed/refractory acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL).

Key Points: 
  • Daiichi Sankyo Company, Limited (hereafter Daiichi Sankyo) today announced the first patient has been dosed in the first-in-human phase 1/2 study of DS-1594, a selective small-molecule menin inhibitor, in adults with relapsed/refractory acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL).
  • The trial is being conducted by The University of Texas MD Anderson Cancer Center under an existing strategic research collaboration.
  • Together with MD Anderson, we will evaluate DS-1594 as a potential therapeutic option for patients with AML or ALL who have exhausted standard treatments.
  • DS-1594 is a potent and selective small molecule menin inhibitor in clinical development in the Alpha portfolio of Daiichi Sankyo.

Jazz Pharmaceuticals Announces FDA Approval of Additional Indication for Vyxeos® (daunorubicin and cytarabine) for the Treatment of Secondary Acute Myeloid Leukemia in Pediatric Patients

Retrieved on: 
Tuesday, March 30, 2021
Acute myeloid leukemia, 7+3, Acute eosinophilic leukemia, Myeloid sarcoma

"While pediatric patients represent a relatively small percentage of total AML patients, there is a critical need for more effective therapies in this setting.

Key Points: 
  • "While pediatric patients represent a relatively small percentage of total AML patients, there is a critical need for more effective therapies in this setting.
  • 1The use of Vyxeos for this indication is supported by evidence of effectiveness from study CPX351-301 in adult patients.
  • Secondary acute myeloid leukemia has a worse outcome than de novo AML, even taking into account cytogenetics and age.
  • Kern W, Haferlach T, Schnittger S, Hiddemann W, Schoch C. Prognosis in therapy-related acute myeloid leukemia and impact of karyotype.J Clin Oncol.2004 Jun 15;22(12):2510-1.

Jazz Pharmaceuticals Announces FDA Approval of Additional Indication for Vyxeos® (daunorubicin and cytarabine) for the Treatment of Secondary Acute Myeloid Leukemia in Pediatric Patients

Retrieved on: 
Tuesday, March 30, 2021
Acute myeloid leukemia, 7+3, Acute eosinophilic leukemia, Myeloid sarcoma

"While pediatric patients represent a relatively small percentage of total AML patients, there is a critical need for more effective therapies in this setting.

Key Points: 
  • "While pediatric patients represent a relatively small percentage of total AML patients, there is a critical need for more effective therapies in this setting.
  • 1The use of Vyxeos for this indication is supported by evidence of effectiveness from study CPX351-301 in adult patients.
  • Secondary acute myeloid leukemia has a worse outcome than de novo AML, even taking into account cytogenetics and age.
  • Kern W, Haferlach T, Schnittger S, Hiddemann W, Schoch C. Prognosis in therapy-related acute myeloid leukemia and impact of karyotype.J Clin Oncol.2004 Jun 15;22(12):2510-1.

INVESTOR ALERT: Kaplan Fox Investigates Potential Securities Fraud at AstraZeneca PLC

Retrieved on: 
Wednesday, March 24, 2021
Dose, Toxicology, 7+3, Clinical trials, Health sciences, Health, COVID-19 vaccines, Adenoviridae

On Nov. 23, 2020, AstraZeneca announced an interim analysis of its trial, revealing that the Company used two different dosing regimens in two smaller scale trials.

Key Points: 
  • On Nov. 23, 2020, AstraZeneca announced an interim analysis of its trial, revealing that the Company used two different dosing regimens in two smaller scale trials.
  • In one trial, patients received a half dose followed by a full dose (resulting in 90% efficacy).
  • Kaplan Fox & Kilsheimer LLP, with offices in New York, San Francisco, Los Angeles, Chicago and New Jersey, has many years of experience in prosecuting investor class actions.
  • For more information about Kaplan Fox & Kilsheimer LLP, you may visit our website at www.kaplanfox.com .