7+3

Immune-Onc Therapeutics Announces First Patient Dosed in Phase I Trial Evaluating IO-202, a First-In-Class Antibody for the Treatment of Acute Myeloid Leukemia

Retrieved on: 
Wednesday, September 16, 2020
Oncology, Health, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Cancer, RTT, Acute myeloid leukemia, Monocytic leukemia, Chronic myelomonocytic leukemia, Leukemia, CMML, Myeloid leukemia, 7+3, Acute myeloblastic leukemia with maturation, Acute eosinophilic leukemia

The Phase I dose escalation and expansion trial will evaluate IO-202 in patients with acute myeloid leukemia (AML) with monocytic differentiation and in chronic myelomonocytic leukemia (CMML).

Key Points: 
  • The Phase I dose escalation and expansion trial will evaluate IO-202 in patients with acute myeloid leukemia (AML) with monocytic differentiation and in chronic myelomonocytic leukemia (CMML).
  • In preclinical studies, IO-202 has shown evidence of activating T cell cytotoxicity against leukemia cells and blocking leukemia infiltration.
  • The dose-escalation phase of the trial will identify the optimal dose of IO-202.
  • Despite advances in treatment, less than 30 percent of acute myeloid leukemia patients are alive five years after initial diagnosis.

Menarini Ricerche Announces Initiation of Cohort Expansion for the Clinical Study of SEL24/MEN1703 in Acute Myeloid Leukemia

Retrieved on: 
Wednesday, September 16, 2020
Menarini, 7+3, Economy of Italy

The above cohort expansion had already started in the US, with the first patient being treated as of 21 July 2020.

Key Points: 
  • The above cohort expansion had already started in the US, with the first patient being treated as of 21 July 2020.
  • DIAMOND-01 is a first-in-Human, Phase I/II dose escalation and cohort expansion trial of SEL24/MEN1703 in AML relapsed or refractory as well as previously untreated patients unsuitable for chemotherapy.
  • Through the work of Menarini Silicon Biosystems, Menarini is also developing advanced technologies and products to study rare cells with single-cell precision.
  • The Menarini Group is a leading international pharmaceutical and diagnostics company, with turnover of 3.793 billion and over 17,000 employees.

Global Acute Myeloid Leukemia (AML) Disease Analysis 2020: Average Probability a Drug Advances from Phase III is 54.2%

Retrieved on: 
Monday, September 14, 2020
RTT, Acute myeloid leukemia, 7+3, Cancer, Oncology, Leukemia, Organic compounds, Clinical medicine, Devimistat, CD135

DUBLIN, Sept. 14, 2020 /PRNewswire/ -- The "Disease Analysis: Acute Myeloid Leukemia (AML)" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Sept. 14, 2020 /PRNewswire/ -- The "Disease Analysis: Acute Myeloid Leukemia (AML)" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • A Phase III trial is enrolling patients with intermediate or unfavorable cytogenetic risk (74% of patients eligible for intensive chemotherapy).
  • The overall likelihood of approval of a Phase I AML asset is 7.5%, and the average probability a drug advances from Phase III is 54.2%.
  • AML drugs, on average, take 10.7 years from Phase I to approval, compared to 9.4 years in the overall oncology space.

Cleave Therapeutics Announces Preclinical Research Collaboration With Jazz Pharmaceuticals in Acute Myeloid Leukemia (AML)

Retrieved on: 
Wednesday, September 9, 2020
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Drugs, RTT, Clinical medicine, Daunorubicin/cytarabine, Acute myeloid leukemia, Daunorubicin, Jazz Pharmaceuticals, Oncology, 7+3, Cytarabine, Vyxeos® (daunorubicin and cytarabine), Cleave Therapeutics and CB-5339

Cleave Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on VCP/p97 as a novel target in oncology, announced that it has entered into a preclinical research collaboration with Jazz Pharmaceuticals, a global biopharmaceutical company developing life-changing medicines for people with serious diseases.

Key Points: 
  • Cleave Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on VCP/p97 as a novel target in oncology, announced that it has entered into a preclinical research collaboration with Jazz Pharmaceuticals, a global biopharmaceutical company developing life-changing medicines for people with serious diseases.
  • CB-5339 plays a key role in DNA damage repair and has demonstrated impressive preclinical activity and synergy in combination with DNA-damaging agents.
  • In Europe, Vyxeos Liposomal (daunorubicin/cytarabine) is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
  • Cleave Therapeutics is a clinical-stage biopharmaceutical company focused on VCP/p97 as a novel target in protein homeostasis and cellular stress pathways for therapeutic use in cancer.

2020 Disease Analysis on Acute Myeloid Leukemia (AML) - ResearchAndMarkets.com

Retrieved on: 
Monday, September 7, 2020
Pharmaceutical, Health, Oncology, Cancer, Clinical medicine, RTT, Nucleosides, Antineoplastic drugs, Lactams, Triazines, 7+3, Hypomethylating agent, Decitabine, Acute myeloid leukemia, Azacitidine

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

Key Points: 
  • The "Disease Analysis: Acute Myeloid Leukemia (AML)" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • The publisher estimates that in 2018, there were 158,400 incident cases of acute myeloid leukemia (AML) worldwide, and expects that number to increase to 169,000 incident cases by 2027.
  • Approximately 60% of newly diagnosed patients are eligible for intensive chemotherapy, such as the 7+3 regimen of cytarabine and daunorubicin.
  • Gone is the era where all front-line patients received either 7+3 chemotherapy or a hypomethylating agent (decitabine or azacitidine).

Kite and HiFiBiO Therapeutics Partner to Discover Novel Targets and Antibodies Against Acute Myeloid Leukemia

Retrieved on: 
Thursday, September 3, 2020
Biotechnology, Hospitals, Health, Pharmaceutical, Oncology, RTT, 7+3, AML, Acute myeloid leukemia

Kite, a Gilead Company (Nasdaq: GILD), and HiFiBiO Therapeutics announced the companies have entered into a two-year research collaboration and license agreement in acute myeloid leukemia (AML).

Key Points: 
  • Kite, a Gilead Company (Nasdaq: GILD), and HiFiBiO Therapeutics announced the companies have entered into a two-year research collaboration and license agreement in acute myeloid leukemia (AML).
  • Through this collaboration, HiFiBiO will use its proprietary technology platforms to identify novel AML targets and anti-AML specific antibodies for Kites use in cell therapies.
  • To date, most efforts to identify AML-specific targets have focused on mining proteomic datasets, as opposed to individual AML patient samples.
  • We look forward to working with Kite to identify disease-relevant targets directly from AML patient samples, said Liang Schweizer, PhD, President and CEO of HiFiBiO Therapeutics.

New Preclinical GlycoMimetics Data Suggests Uproleselan With Venetoclax/HMA in AML May Prolong Survival

Retrieved on: 
Monday, August 31, 2020
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical trials, Chemical compounds, Organic compounds, RTT, Breakthrough therapy, Chloroarenes, Piperazines, Sulfonamides, Venetoclax, 7+3, Leukemia, Uproleselan (GMI-1271), GlycoMimetics, Inc.

In this model, the addition of uproleselan to the treatment regimen demonstrated robust anti-leukemic activity and a statistically significant prolongation of survival.

Key Points: 
  • In this model, the addition of uproleselan to the treatment regimen demonstrated robust anti-leukemic activity and a statistically significant prolongation of survival.
  • The research strongly supports the opportunity for additional clinical evaluation of the triple combination of uproleselan, venetoclax and HMA in the frontline, unfit AML patient population.
  • This preclinical study shows that by blocking this activity with uproleselan, we can enhance the sensitivity to venetoclax/HMAs.
  • In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed or refractory patients with AML.

Smiths Medical Issues Worldwide Notification Regarding Potential for Inappropriate Bolus or Loading Dose Delivery in Certain Medfusion® 3500 and 4000 Infusion Pumps

Retrieved on: 
Wednesday, August 19, 2020
Medical Supplies, Medical devices, FDA, Health, Pharmaceutical, Biotechnology, Health, Pharmacology, Dosage forms, Routes of administration, Bolus, 7+3, Insulin pump

Due to a software error, if a bolus or loading dose is interrupted and a specific sequence of events occurs, over- or under- delivery of a bolus or loading dose may occur.

Key Points: 
  • Due to a software error, if a bolus or loading dose is interrupted and a specific sequence of events occurs, over- or under- delivery of a bolus or loading dose may occur.
  • Medfusion 4000 Syringe Pump Firmware Versions 1.5.0; 1.5.1; 1.6.0; 1.6.1; 1.7.0
    Affected Models listed above were distributed by Smiths Medical from 2013 to 2020.
  • In the Affected Models listed above, when an operator: (1) Programs a Bolus or Loading Dose, (2) Initiates the Bolus or Loading Dose, (3) Interrupts the Bolus or Loading Dose, (4) Primes the pump, and (5) Resumes the Bolus or Loading Dose instead of beginning a new infusion, over- delivery or under-delivery of medication may occur.
  • For any reason, when a bolus or loading dose delivery is interrupted and mechanically primed using the PRIME FUNCTION, cancel the bolus or loading dose and begin a new infusion to avoid potential over-delivery or under-delivery of medication.

Journal of Clinical Oncology Publishes Additional Data from Clovis Oncology’s TRITON2 Clinical Trial Evaluating Rubraca® (rucaparib) for the Treatment of mCRPC in Patients with BRCA1/2 Gene Mutations

Retrieved on: 
Monday, August 17, 2020
Research, Pharmaceutical, Oncology, Hospitals, Genetics, Public relations, Investor relations, Clinical trials, Science, Biotechnology, Communications, Medical Supplies, FDA, Health, RTT, Blood disorders, Clinical medicine, Medical specialties, Acute myeloid leukemia, Myelodysplastic syndrome, 7+3, Midostaurin, Atypical localization of immature precursors, Rubraca (rucaparib), Clovis Oncology

These additional data presented in this publication provide physicians important information to inform treatment decisions for their eligible patients.

Key Points: 
  • These additional data presented in this publication provide physicians important information to inform treatment decisions for their eligible patients.
  • Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) has occurred in patients treated with Rubraca, and are potentially fatal adverse reactions.
  • In TRITON2, MDS/AML was not observed in patients with mCRPC (n=209) regardless of homologous recombination deficiency (HRD) mutation.
  • Advise male patients not to donate sperm during therapy and for 3 months following the last dose of Rubraca.

Fera Pharmaceuticals Announces the Launch of Dexamethasone 4 mg Tablets USP in Unit Dose Packaging

Retrieved on: 
Monday, August 10, 2020
Infectious diseases, Other Health, Hospitals, Health, Pharmaceutical, Health, Packaging, Pharmacology, Articles, Labels, Blister pack, Packaging and labeling, Dose, Dosage form, 7+3, Pharmaceutical industry in China, Dosing

Fera is pleased to announce that, in addition to its already marketed 100-count bottle package size, it has now launched a 100-count unit dose blister package as well.

Key Points: 
  • Fera is pleased to announce that, in addition to its already marketed 100-count bottle package size, it has now launched a 100-count unit dose blister package as well.
  • The advantages of unit dose packaging include improved safety for hospital staff and patients and to help minimize inaccurate dosing.
  • Fera Pharmaceuticals is a privately held company.
  • The company goal is to realize opportunities via acquisitions, in-licensing, developing and marketing abbreviated new drug applications (ANDAs), new drug applications (NDAs) and 505(b)(2) NDA products.