Cyclophosphamide

Lipella Pharmaceuticals Announces FDA Type C Meeting for LP-10 for Hemorrhagic Cystitis

Retrieved on: 
Wednesday, April 3, 2024
Urinalysis, Type, HC, Patient, History, Tacrolimus, Urine, Ifosfamide, Nephrology, Breast cancer, Hemorrhagic cystitis, Safety, FDA, Cyclophosphamide, Food, Pharmaceutical industry

Lipella expects to meet with the FDA on May 21, 2024.

Key Points: 
  • Lipella expects to meet with the FDA on May 21, 2024.
  • HC is a serious, life-threatening form of gross hematuria (i.e.
  • Lipella published these results in the peer-reviewed journal, International Urology and Nephrology , in September 2023, and received preliminary guidance from the FDA regarding potential registration endpoints.
  • The company’s anticipated Type C meeting with the FDA will focus on reaching an agreement for the proposed Phase-2b trial design, which Lipella expects to be a 36-subject, prospective, double-blind, placebo-controlled study with a primary efficacy assessment derived from the reduction in patient-reported frequency of gross hematuria episodes over a seven-day period.

Panbela Provides Business Update and Reports Q4 and FY 2024 Financial Results

Retrieved on: 
Tuesday, March 26, 2024
Research, Topotecan, PBLA, Neuroblastoma, Patient, Data monitoring committee, Acquisition, Celecoxib, Doctor of Philosophy, AACR, MSN, CPP, Pancreatic cancer, Therapy, DSMB, Poster, DFMO, Cyclophosphamide, Pharmaceutical industry

MINNEAPOLIS, March 26, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (NASDAQ:PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today provides a business update and reports financial results for the quarter and full year ended December 31, 2023.

Key Points: 
  • MINNEAPOLIS, March 26, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (NASDAQ:PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today provides a business update and reports financial results for the quarter and full year ended December 31, 2023.
  • “Looking ahead, Panbela remains unwavering in its commitment to patients and in its pursuit of maximizing value for stockholders.
  • Notes payable, plus accrued interest, on the balance sheet, the result of the acquisition of CPP, totaled approximately $5.4 million.
  • Gross proceeds from the raise, which closed on January 31, 2024, were approximately $9 million.

Salarius Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Friday, March 22, 2024
Research, Topotecan, TC, LSD1, Survival, Bone marrow, Progression-free survival, DCR, Patient, Acquisition, Deuterium, NHL, IND, Myelodysplastic syndrome, Non-Hodgkin lymphoma, Clinical trial, Azacitidine, Chronic myelomonocytic leukemia, Probability, Cyclophosphamide, FDA, MD Anderson Cancer Center, Ewing sarcoma, Consultant, Food, Pharmaceutical industry

HOUSTON, March 22, 2024 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment options, today reported financial results for the three and 12 months ended December 31, 2023 and provided a business update.

Key Points: 
  • Cash and cash equivalents were $5.9 million as of December 31, 2023, compared with $12.1 million as of December 31, 2022.
  • In August 2023 Salarius announced a comprehensive review of strategic alternatives focused on maximizing shareholder value.
  • Research and development expenses were $0.06 million for the fourth quarter of 2023, compared with $4.7 million for the fourth quarter of 2022, reflecting the above-mentioned cost-savings plan.
  • Net cash used for operating activities during the fourth quarter of 2023 was $1.5 million, compared with $4.7 million during the same quarter in 2022, reflecting the above-mentioned cost-savings plan.

Cabaletta Bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 21, 2024
Research, MPV, IIM, MuSK protein, Toxicity, Conference, Disease, Dermatomyositis, Juvenile dermatomyositis, Federation, Patient, NOL, Observation, CRS, SLE, Health Canada, IND, Immunoglobulin therapy, Pemphigus, Investment, Investigational New Drug, Myopathy, Systemic scleroderma, Marketing, FDA, Clinical trial, Cytokine release syndrome, Cyclophosphamide, CD19, Food, Autoimmune disease, Pharmaceutical industry

In October 2023, Cabaletta received Investigational New Drug (IND) application clearance from the U.S. Food and Drug Administration (FDA) for the Phase 1/2 RESET-SSc trial.

Key Points: 
  • In October 2023, Cabaletta received Investigational New Drug (IND) application clearance from the U.S. Food and Drug Administration (FDA) for the Phase 1/2 RESET-SSc trial.
  • In November 2023, Cabaletta announced that its IND application for CABA-201 was allowed to proceed by the FDA for the Phase 1/2 RESET-MG trial.
  • Cabaletta anticipates reporting initial clinical data from the Phase 1/2 RESET-MG trial in the second half of 2024.
  • As of December 31, 2023, Cabaletta had cash, cash equivalents and short-term investments of $241.2 million, compared to $106.5 million as of December 31, 2022.

Allogene Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Update

Retrieved on: 
Thursday, March 14, 2024
Research, Kite Pharma, PIN, CLL, Disease, AID, Patient, EFS, Observation, Pivotal, Cancer, Renal cell carcinoma, Bank statement, News, RCC, Therapy, CRISPR, Projection, MRD, GAAP, Autoimmune disease, Cyclophosphamide, CD19, Pharmaceutical industry

These restated financial statements have no impact on the Company’s cash, cash equivalents and marketable investments, cash runway or business operations.

Key Points: 
  • These restated financial statements have no impact on the Company’s cash, cash equivalents and marketable investments, cash runway or business operations.
  • Research and development expenses were $54.7 million for the fourth quarter of 2023, which includes $7.0 million of non-cash stock-based compensation expense.
  • General and administrative expenses were $17.2 million for the fourth quarter of 2023, which includes $8.2 million of non-cash stock-based compensation expense.
  • Allogene will host a live conference call and webcast today at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss financial results and provide a business update.

GenFleet and BeiGene Enter into Trial Collaboration for a Potentially First-in-class Combination Therapy to Initiate Phase Ib/II Study of GFH009 (CDK9 inhibitor) and BRUKINSA® (zanubrutinib) Treating Diffuse Large B Cell Lymphoma

Retrieved on: 
Thursday, March 28, 2024
B-cell lymphoma, Plasma, Shanghai Cancer Center, Rituximab, Apoptosis, Leukemia, International Journal of Hematology, Patient, Hospital, Doxorubicin, Vincristine, Fudan University, CC3, Standard of care, Acute myeloid leukemia, Epidemiology, Biomedical Chromatography, Prednisone, Peripheral T-cell lymphoma, PARP, National Cancer Center, Therapy, MYC, BTK, Safety, BeiGene, CDK9, Cyclophosphamide, DLBCL, Canadian International Council, MCL1, Follicular lymphoma, Pharmaceutical industry

The first patient was dosed in the trial led by prominent Henan Cancer Hospital and Fudan University Shanghai Cancer Center.

Key Points: 
  • The first patient was dosed in the trial led by prominent Henan Cancer Hospital and Fudan University Shanghai Cancer Center.
  • This study will be the first combination trial conducted by a Chinese biotech to combine CDK9 inhibitor and BTK inhibitor targeting DLBCL.
  • The trials of GFH009 treating peripheral T-cell lymphoma and acute myeloid leukemia have entered into phase II stage in China and the U.S. respectively.
  • Epidemiology of diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) in the United States and Western Europe: population-level projections for 2020–2025, Leukemia & Lymphoma, 2021
    3.

Withdrawn application: Adcetris, 23/02/2024

Retrieved on: 
Wednesday, April 3, 2024
PTCL-NOS, Lymphoma, B-cell lymphoma, CHOP, Patient, PTCL, Doxorubicin, Vincristine, CHP, Cancer, Vinblastine, European Medicines Agency, CTCL, Prednisone, Lymphocyte, Agency, Clinical trial, Skin, Dacarbazine, CD30, Cyclophosphamide, Medicine

Adcetris was designated an ‘orphan medicine’ (a medicine used in rare diseases) for peripheral T cell lymphoma 21 August 2019.

Key Points: 
  • Adcetris was designated an ‘orphan medicine’ (a medicine used in rare diseases) for peripheral T cell lymphoma 21 August 2019.
  • The cytotoxic molecule then enters the cancer cells and prevents them from dividing, causing the cancer cells to die.
  • The application was withdrawn after the European Medicines Agency had evaluated the initial information from the company and had prepared questions for the company.
  • If you are in a clinical trial and need more information about your treatment, speak with your clinical trial doctor.

Salarius Provides Update on Strategic Review Process and Plans to Support Ongoing Seclidemstat Clinical Trials by Further Reducing Expenses

Retrieved on: 
Thursday, February 22, 2024
Ewing sarcoma, Cyclophosphamide, Canaccord Genuity, Chairperson, Patient, Clinical trial, MD Anderson Cancer Center, TC, Cancer, Pharmaceutical industry

HOUSTON, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing therapies for patients with cancer in need of new treatment options, today announced that its Board of Directors is implementing a series of additional cost-savings measures designed to extend Salarius’ expected cash runway into the first half of 2025. These measures will allow Salarius to support the generation of additional clinical data for seclidemstat in the ongoing MD Anderson Cancer Center (MDACC) investigator-initiated Phase 1/2 clinical trial in hematologic cancers and Salarius’ Phase 1/2 trial in Ewing sarcoma.

Key Points: 
  • These measures will allow Salarius to support the generation of additional clinical data for seclidemstat in the ongoing MD Anderson Cancer Center (MDACC) investigator-initiated Phase 1/2 clinical trial in hematologic cancers and Salarius’ Phase 1/2 trial in Ewing sarcoma.
  • “With these additional expense reductions, we are able to extend our cash runway to allow for the generation of additional clinical data in both seclidemstat clinical trials.
  • “By further reducing expenses, we are able to support the ongoing clinical development of seclidemstat into the first half of 2025.
  • We look forward to reviewing the updated clinical data from both trials later this year and to sharing those data with prospective strategic partners and other interested parties.”

Agendia Presents Data at Miami Breast 2024 Demonstrating MammaPrint® + BluePrint®’s Ability to Further Stratify Tumor Categories in Hormone-Positive Breast Cancer, Highlighting Response to Different Chemotherapy Regimens

Retrieved on: 
Friday, March 8, 2024
Research, Genetics, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, Gene expression profiling, Breast cancer, Neoplasm, Taxane, Woman, Transcriptome, MD, MBCC, Cyclophosphamide, Anthracycline, PCR, MammaPrint, Risk, Conference, Symantec Endpoint Protection, AC-T, Patient, MP, Diagnosis, Triple-negative breast cancer, Blueprint, TC, Medical imaging

The first poster, titled MammaPrint® and BluePrint® predict anthracycline chemosensitivity in patients with HR+HER2-early-stage breast cancer enrolled in FLEX, (Audeh, W., et al.

Key Points: 
  • The first poster, titled MammaPrint® and BluePrint® predict anthracycline chemosensitivity in patients with HR+HER2-early-stage breast cancer enrolled in FLEX, (Audeh, W., et al.
  • ), investigates the associations between MammaPrint and BluePrint classifications, therapy regimen, and the likelihood of achieving a pathologic Complete Response (pCR).
  • The second poster, titled Prediction of chemotherapy benefit by MammaPrint® in patients with HR+HER2-early-stage breast cancer from real-world evidence studies (Audeh, W., et al.
  • Taken together, these findings indicate the utility of MammaPrint to predict neoadjuvant and adjuvant chemotherapy benefit in this patient population.

BioVaxys Acquires All Intellectual Property, Immunotherapeutics Platform Technology, and Clinical Stage Assets of the Former IMV Inc.

Retrieved on: 
Monday, February 12, 2024
Growth, Sale, Ovarian cancer, Protein, Intellectual property, CD8, B cell, Cyclophosphamide, BRCA, APC, Pet, Pfizer, CD4, FRA, Allergy, Vaccine, IMV, Peptide, Limited partnership, Antigen, Patent, Infection, DLBCL, Acquisition, Merck, Livestock, USD, Messenger, DSM-IV codes, Cancer, Platinum, Survivin, Patient, Medicine

HIMV will also be entitled to appoint an observer to BioVaxys's Board of Directors.

Key Points: 
  • HIMV will also be entitled to appoint an observer to BioVaxys's Board of Directors.
  • The DPX™ antigen delivery platform acquired by BioVaxys is designed to stimulate a specific, coordinated and persistent anti-tumor immune response, improving the lives of patients with solid or hematological cancers.
  • These elements foster maturation of antigen presenting cells as well as robust activation of CD8 T cell effector and memory function.
  • Findings showed clinical benefit to patients with recurrent ovarian cancer, regardless of platinum sensitivity or BRCA mutational status.