Chemotherapy

Azitra, Inc. Announces Q1 2024 Financial Results and Provides Business Updates

Retrieved on: 
Donnerstag, Mai 9, 2024
Biotechnology, Other Health, Health, Pharmaceutical, Clinical Trials, FDA, Society, Cancer, Skin, Safety, Research, Joint, Research and development, IRB, Cell, Administration, IND, LEKTI, ASCO, Ichthyosis, Patent, Patient, Gene, Bayer, Prevalence, Rash, Quarter, EGFR, G&A, Netherton syndrome, BTK, Chemotherapy, Pharmaceutical industry

Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the three months ended March 31, 2024, and provided a business update.

Key Points: 
  • Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the three months ended March 31, 2024, and provided a business update.
  • Moreover, preclinical evidence suggests that ATR-12 can markedly reduce IL-36g, a pro-inflammatory cytokine implicated in Netherton syndrome, further validating the potential of our approach.
  • Net Loss was $2.9 million for the quarter ended March 31, 2024, compared to $2.5 million for the comparable period in 2023.
  • Cash and cash equivalents: As of March 31, 2024, the Company had cash and cash equivalents of $3.0 million.

Merck Provides Update on Phase 3 KEYLYNK-006 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus Maintenance LYNPARZA® (olaparib) for Certain Patients With Metastatic Nonsquamous Non-Small Cell Lung Cancer

Retrieved on: 
Donnerstag, März 21, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, OS, Pemetrexed, Chemotherapy, NSCLC, Progression-free survival, Patient, Carboplatin, Merck & Co., MRK, PARP, Cisplatin, PFS, Pharmaceutical industry

In the KEYLYNK-006 trial, KEYTRUDA in combination with chemotherapy followed by KEYTRUDA plus maintenance LYNPARZA did not meet the study’s pre-specified statistical criteria for OS or PFS compared to KEYTRUDA in combination with chemotherapy (pemetrexed plus carboplatin or cisplatin) followed by KEYTRUDA plus maintenance chemotherapy (pemetrexed).

Key Points: 
  • In the KEYLYNK-006 trial, KEYTRUDA in combination with chemotherapy followed by KEYTRUDA plus maintenance LYNPARZA did not meet the study’s pre-specified statistical criteria for OS or PFS compared to KEYTRUDA in combination with chemotherapy (pemetrexed plus carboplatin or cisplatin) followed by KEYTRUDA plus maintenance chemotherapy (pemetrexed).
  • The safety profiles of KEYTRUDA and LYNPARZA in this trial were consistent with those observed in previously reported studies for the individual therapies.
  • “These results are an important reminder of how challenging it may be to treat these patients with metastatic nonsquamous non-small cell lung cancer.
  • We sincerely thank the patients and investigators for their important contributions to this study.”

Azitra, Inc. Announces Full Year 2023 Financial Results and Provides Business Updates

Retrieved on: 
Freitag, März 15, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, Genetics, Clinical Trials, Other Health, Prevalence, Administration, EGFR, Ichthyosis, Joint, Patient, Netherton syndrome, G&A, Cancer, IND, Rash, Bayer, Clinical trial, Research and development, Skin, BTK, Patent, FDA, Chemotherapy, Pharmaceutical industry

Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the full year ended December 31, 2023, and provided a business update.

Key Points: 
  • Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the full year ended December 31, 2023, and provided a business update.
  • Completed and filed post-IND, FDA commitments for characterization of drug substance and drug product for ATR-12.
  • Selected and hired clinical research organization for ATR-12 clinical trial and selected initial clinical sites for activation.
  • Net Loss was $11.3 million for the year ended December 31, 2023, compared to $10.7 million for the comparable period in 2022.

ChemoMouthpiece, LLC. Announces the Awarding of the 510(k) Marketing Clearance by the FDA for their Oncology Supportive Care Device and Recent Closing of their Private Placement Round

Retrieved on: 
Donnerstag, Februar 22, 2024
Vasoconstriction, Incidence, Marketing, ONS, Oncology Nursing Society, Multimedia, ASCO, FDA, News, Pain, Hodgkin lymphoma, Cryotherapy, Nausea, Manuscript, Risk, Mouth, Society, Wastewater treatment, Patient, Chemotherapy, Clinical trial, Lymphoma, Mucositis, Dentistry

announces the FDA 510(k) Marketing Clearance for their device, The Chemo Mouthpiece™.

Key Points: 
  • announces the FDA 510(k) Marketing Clearance for their device, The Chemo Mouthpiece™.
  • has just closed on their Private Placement Round of $10 million in upfront capital with a full commitment for the second tranche of additional funds in excess of $10 million.
  • "Chemo Mouthpiece™ is fully stocked, as we will begin shipping across the US within the next quarter now that we have FDA Marketing Clearance.
  • ChemoMouthpiece, LLC is a privately held medical device company that develops and commercializes propriety oral cryotherapy products for cancer patients.

Human medicines European public assessment report (EPAR): Carmustine medac (previously Carmustine Obvius), carmustine, Date of authorisation: 18/07/2018, Revision: 10, Status: Authorised

Retrieved on: 
Freitag, Januar 5, 2024
RNA, Medical Subject Headings, Brain, Marketing, Agency, Health, INN, Risk, Stomach, Ependymoma, ATC, Medulloblastoma, Radiation, International, Blood, Language, DNA, Literature, Hodgkin lymphoma, Chemotherapy, Cancer, Skin cancer, Glioblastoma, Astrocytoma, Haematopoiesis, European Medicines Agency, Neoplasm, Transplant, Select, Cell, Patient, Anatomy, IIA, Medical device

Human medicines European public assessment report (EPAR): Carmustine medac (previously Carmustine Obvius), carmustine, Date of authorisation: 18/07/2018, Revision: 10, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Carmustine medac (previously Carmustine Obvius), carmustine, Date of authorisation: 18/07/2018, Revision: 10, Status: Authorised

Trevena Announces TRV045 Presentation at the American College of Neuropsychopharmacology 62nd Annual Meeting

Retrieved on: 
Montag, Dezember 4, 2023
Epilepsy, Pain, Disease, Chemotherapy, Chemotherapy-induced peripheral neuropathy, CIPN, Trevena, Neuropathic pain, Central nervous system disease, CNS, Bangladesh Technical Education Board, Poster, American College, Single, NIH, Patient, Central nervous system, Senior, Vaccine

CHESTERBROOK, Pa., Dec. 04, 2023 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced a poster presentation at the 62nd Annual Meeting for the American College of Neuropsychopharmacology (ACNP). The conference is being held from December 3rd to 6th, 2023.

Key Points: 
  • CHESTERBROOK, Pa., Dec. 04, 2023 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced a poster presentation at the 62nd Annual Meeting for the American College of Neuropsychopharmacology (ACNP).
  • The poster discussed the potential utility of TRV045 for the treatment of chemotherapy-induced peripheral neuropathy (CIPN) using an established nonclinical model.
  • CIPN is a nerve-damaging side effect of antineoplastic agents and occurs in approximately 70% of oncology patients undergoing chemotherapy.
  • Oral administration of TRV045 reduced mechanical and cold stimulus-evoked nociception in a dose-related manner in a mouse model of CIPN.

Azitra, Inc. Announces Third Quarter 2023 Financial Results and Business Updates

Retrieved on: 
Dienstag, November 14, 2023
Science, Biotechnology, Research, Pharmaceutical, Health, Genetics, Clinical Trials, Other Health, Three Months, NYSE, Rash, Joint, BTK, Chemotherapy, IND, Clinical trial, Skin, Administration, Patient, Research and development, Prevalence, FDA, Bayer, Investigational New Drug, Netherton syndrome, R, EGFR, Fine chemical, Pharmaceutical industry, Cryptocurrency, Netherton

Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the third quarter ended September 30, 2023.

Key Points: 
  • Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the third quarter ended September 30, 2023.
  • Selected initial sites for activation
    Francisco Salva, Chief Executive Officer of Azitra, commented:
    “During the third quarter, we made important progress towards reaching multiple significant near-term milestones.
  • Additionally, we are in discussion with our lead sites to get the program activated and start recruiting an initial ~12 patients.
  • Net Loss was $1.9 million for the three months ended September 30 2023, compared to $2.4 million for the same period in 2022.

Human medicines European public assessment report (EPAR): Jaypirca, pirtobrutinib, Date of authorisation: 30/10/2023, Status: Authorised

Retrieved on: 
Montag, Dezember 18, 2023
Mantle cell lymphoma, Anatomy, Select, Urine, ATC, Protein kinase inhibitor, Neutrophil, Anemia, BTK, Pneumonia, MCL, International, INN, Disease, Language, Tablet, EMA, Patient, IIA, Marketing, Medical Subject Headings, Diarrhea, Neutropenia, Cancer, Infection, Bruise, Growth, Mouth, Fatigue, Urinary tract infection, Chemotherapy, Instrumentation, Vaccine, Pharmaceutical industry, Medicinal plants, Medical device, Medical imaging, Online shopping, Bookkeeping, Medicine, Lymphoma, Pirtobrutinib

Mantle cell lymphoma is rare, and Jaypirca was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 21 June 2021.

Key Points: 
  • Mantle cell lymphoma is rare, and Jaypirca was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 21 June 2021.
  • Treatment should be started and supervised by a doctor experienced in the use of cancer medicines.
  • Treatment should be continued until the disease gets worse or the patient gets unacceptable side effects.
  • Jaypirca : EPAR - Medicine overview
    Product information
    Jaypirca : EPAR - Product information
    This medicine’s product information is available in all official EU languages.

Real World Data Shows Impact of Immunotherapy in Populations Underrepresented in Clinical Trials, According to JNCCN Study

Retrieved on: 
Montag, Dezember 11, 2023
Case Comprehensive Cancer Center, Assistant, Associate, Research, Safety, NCCN, Progression-free survival, Thymic carcinoma, White, National Comprehensive Cancer Network, Disease, Insurance, Patient, Pembrolizumab, Lung cancer, BMI, ECOG, MPH, Survival, Doctor of Philosophy, Immunotherapy, Chemotherapy, NSCLC, Birth control, Medical imaging, Pharmaceutical industry, Medicine, MD, Oncology

PLYMOUTH MEETING, Pa., Dec. 11, 2023 /PRNewswire/ -- New research in the December 2023 issue of JNCCN—Journal of the National Comprehensive Cancer Network finds patients treated with first-line immunotherapy for advanced Non-Small Cell Lung Cancer (NSCLC) showed similar results in terms of survival, progression-free survival, and treatment duration, regardless of race or ethnicity, even with differences in income and insurance. The clinical investigators focused on patients in under-represented groups who were typically less likely to be included in the immunotherapy clinical trials that have been conducted to date. They analyzed results from 248 patients treated with pembrolizumab over a 9-year period between January 1, 2013 and June 1, 2022, with non-Hispanic Black, Hispanic, and Non-Hispanic White patients each accounting for an approximately equal percentage. Median overall survival was 16.8 to 26.3 months, similar to results previously reported in large prospective clinical trials.

Key Points: 
  • The clinical investigators focused on patients in under-represented groups who were typically less likely to be included in the immunotherapy clinical trials that have been conducted to date.
  • Median overall survival was 16.8 to 26.3 months, similar to results previously reported in large prospective clinical trials.
  • This study could change how we take care of patients and plan future lung cancer studies to better include all patients.
  • "There is a clear need for future studies to include underrepresented patient groups in clinical trials to validate these findings and to better guide clinical practice."

Lyme & Other Tick-Borne Diseases: Research & Clinical Advances 2023

Retrieved on: 
Donnerstag, Oktober 5, 2023
Lyme, AMA, Doctor of Philosophy, Chemotherapy, Faculty, POTS, Late, Lyme disease, COVID, CME, MD, New Lyme, B cell, LDA, Columbia University Vagelos College of Physicians and Surgeons, MBI, Mast cell, Syndrome, Physician, Surgeon, Notifiable disease, Pharmaceutical industry, Vaccine, Microbiology, Babesia

JACKSON, N.J., Oct. 5, 2023 /PRNewswire/ -- Lyme Disease Association Inc. (LDA) will hold its 22nd annual scientific conference, Lyme & Other Tick-Borne Diseases: Research & Clinical Advances 2023, virtually on October 13-14, 2023.

Key Points: 
  • JACKSON, N.J., Oct. 5, 2023 /PRNewswire/ -- Lyme Disease Association Inc. (LDA) will hold its 22nd annual scientific conference, Lyme & Other Tick-Borne Diseases: Research & Clinical Advances 2023, virtually on October 13-14, 2023.
  • LDA and Columbia Vagelos College of Physicians and Surgeons are joint providers of the CME conference designed for medical & health professionals & researchers but open to the general public.
  • Topics include Lyme & COVID, Cancer Drug May Help Lyme, Psychedelics, Long-Term Lyme Treatments, Lyme Treatment Trials, Pathogens in Post Mortem Tissue, Mast Cell activation, Alpha-gal, Diagnostics, Eye Screening for Lyme, POTS, and Babesia.
  • Columbia University Vagelos College of Physicians and Surgeons designates this live activity for a maximum of 13.25 AMA PRA Category 1 Credits™.