Peripheral neuropathy

Artelo Biosciences Presents Important New Data on ART26.12 at the 57th Annual Scientific Meeting of the British Pain Society

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火曜日, 6月 4, 2024
Diabetic neuropathy, Fatty acid, Pain, Analgesic, Investigational New Drug, Cancer, Food, FABP5, Diabetes, Plasma, Peripheral neuropathy, Neuropathic pain, Pharmaceutical industry

The conference is being held from June 4-6, 2024, in Nottingham, UK.

Key Points: 
  • The conference is being held from June 4-6, 2024, in Nottingham, UK.
  • Specifically, effective doses and plasma exposures are consistent with previously published data of ART26.12 in oxaliplatin-induced peripheral neuropathy ( https://www.jpain.org/article/S1526-5900(24)00345-6/fulltext ).
  • ART26.12 represents a significant advancement in the Company’s commitment to developing innovative therapies targeting lipid signaling pathways.
  • As previously announced, Artelo plans to submit an Investigational New Drug application to the U.S. Food and Drug Administration for the treatment of neuropathic pain this month.

SYS6002 (CRB-701) A Next-Generation Nectin-4 Targeting Antibody Drug Conjugate Continues to Demonstrate Encouraging Safety and Efficacy Observed in Patients with Nectin-4 Positive Tumors in a Clinical Update Presented at ASCO 2024

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土曜日, 6月 1, 2024
Aes, Șaeș, Rash, ASCO, MMAE, Patient, Hypokalemia, DCR, Corbus, Administration, Generator, Data, Peripheral neuropathy, Trial of the century, Safety, Oncology, Society, ADC, Shanghai Cancer Center, Infrared spectroscopy correlation table, Anemia, Poster, Fudan University, Cervical cancer, Conference, Pharmaceutical industry

Patients were enrolled based on Nectin-4 staining with the exception of metastatic urothelial cancer (mUC) patients who were considered to be Nectin-4 positive.

Key Points: 
  • Patients were enrolled based on Nectin-4 staining with the exception of metastatic urothelial cancer (mUC) patients who were considered to be Nectin-4 positive.
  • “This latest data update provides additional insight following the initial observations from our partner CSPC’s January 2024 data cut,” said Dr. Dominic Smethurst, Chief Medical Officer at Corbus.
  • “This larger set of patient data, along with additional confirmed responses, increases our confidence that CRB-701 is clinically active.
  • Similarly, we find the emerging safety data reassuring with its low rates of skin rash and peripheral neuropathy and very few grade 3 adverse events.

Investigational Tisotumab Vedotin Phase 2 Data Demonstrates Encouraging Antitumor Activity in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

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月曜日, 6月 3, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, TTR, Patient, Peripheral neuropathy, HNSCC, Pharynx, Immunotherapy, Cetuximab, Corr, Diagnosis, Head, Taxane, CPI, Part, Larynx, Pharmaceutical industry

The study showed 32.5% of patients achieved a confirmed objective response rate (cORR), one patient experienced a complete response (CR) and 12 achieved a partial response (PR).

Key Points: 
  • The study showed 32.5% of patients achieved a confirmed objective response rate (cORR), one patient experienced a complete response (CR) and 12 achieved a partial response (PR).
  • These results were presented in a rapid oral session today at the 2024 ASCO Annual Meeting, being held in Chicago, Illinois, May 31 – June 4, 2024.
  • Grade ≥3 treatment-emergent adverse events (TEAEs) occurred in 67.5% of patients, and the most common were peripheral neuropathy events (40%).
  • As of December 2023, 40 patients with recurrent or metastatic HNSCC were treated with tisotumab vedotin monotherapy (1.7 mg/kg intravenously, once every two weeks).

Pfizer’s LORBRENA® CROWN Study Shows Majority of Patients with ALK-Positive Advanced Lung Cancer Living Beyond Five Years Without Disease Progression

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金曜日, 5月 31, 2024
Research, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, Oncology, Traffic barrier, Lung, Principal, Progression-free survival, Patient, Diarrhea, Anaplastic lymphoma kinase, Headache, Cough, Weight gain, Learning, Hypercholesterolemia, Risk, Hypertriglyceridemia, Inc., Lung cancer, Doctor of Philosophy, Arthralgia, PFS, Disease, Edema, NSCLC, APLS, Death, Peripheral neuropathy, HR, Abstract, Periodic breathing, Hypertension, PFE, ASCO, Journal, Brain, Society, ALK, Confidence interval, Aes, MBBS, Crizotinib, Pharmaceutical industry

Further, 60% of patients treated with LORBRENA (95% CI, 51-68) were alive without disease progression after five years compared to 8% (3-14) on the XALKORI treatment arm.

Key Points: 
  • Further, 60% of patients treated with LORBRENA (95% CI, 51-68) were alive without disease progression after five years compared to 8% (3-14) on the XALKORI treatment arm.
  • “These results from the CROWN trial are unprecedented, as the majority of patients on LORBRENA are living beyond five years without disease progression,” said Roger Dansey, M.D., Chief Development Officer, Oncology, Pfizer.
  • “This updated analysis shows that LORBRENA helped patients live longer without disease progression, with the majority of patients experiencing sustained benefit for over five years, including nearly all patients having protection from progression of disease in the brain.
  • At the time of analysis, 50% of patients in the CROWN trial were still receiving LORBRENA compared to 5% of patients receiving XALKORI.

FibroGen Announces Presentation of Positive Interim Data from the Phase 1b Study of FG-3246 (FOR46) in Combination with Enzalutamide in Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC) at the 2024 American Society of Clinical Oncology

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木曜日, 5月 23, 2024
Patient, MTD, Food, Neutropenia, University, CDT, FDA, ABW, SAN, Castration, ADC, Peripheral neuropathy, Prostate cancer, MMAE, Spacecraft, CD46, ASCO, Enza, Fatigue, Society, Weight loss, Arsis, Principal, Annual general meeting, Pharmaceutical industry

“We are excited to announce that FG-3246 in combination with enzalutamide in patients with mCRPC demonstrated clinically meaningful early signals of efficacy,” commented Deyaa Adib, M.D., Chief Medical Officer of FibroGen.

Key Points: 
  • “We are excited to announce that FG-3246 in combination with enzalutamide in patients with mCRPC demonstrated clinically meaningful early signals of efficacy,” commented Deyaa Adib, M.D., Chief Medical Officer of FibroGen.
  • Over 70% of the patients in the study received at least two prior ARSIs, which included prior enzalutamide treatment.
  • The primary endpoint was determination of the maximally tolerated dose (MTD) of FG-3246 in combination with enzalutamide.
  • The MTD was established at 2.1 mg/kg ABW, with primary G-CSF prophylaxis, in combination with enzalutamide 160 mg/day.

NeuroMetrix Reports Q1 2024 Business Highlights

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水曜日, 5月 15, 2024
Patient, Prescription, CMS, Medicare, Hayashi, Absorption, Fibromyalgia, EKG, Peripheral neuropathy, DSM-IV codes, Environment, Pharmaceutical industry

WOBURN, Mass., May 15, 2024 (GLOBE NEWSWIRE) -- NeuroMetrix, Inc. (Nasdaq: NURO) today reported financial and business highlights for the quarter ended March 31, 2024.

Key Points: 
  • WOBURN, Mass., May 15, 2024 (GLOBE NEWSWIRE) -- NeuroMetrix, Inc. (Nasdaq: NURO) today reported financial and business highlights for the quarter ended March 31, 2024.
  • Revenue in Q1 2024 of $1.1 million was lower by $0.6 million or 37% from Q1, 2023 primarily due to reduced sales volume for DPNCheck.
  • Operating expenses were $3.8 million in Q1 2024, an increase of $0.9 million from the comparable period in 2023.
  • The Q1 2024 net loss was $3.0 million ($1.67 per share) versus a net loss of $1.6 million ($1.64 per share) in Q1 2023.

Corbus Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Corporate Update

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火曜日, 5月 7, 2024
FDA, Carcinoma, CMO, Peripheral neuropathy, Investment, Safety, Pharmacokinetics, Rash, MMAE, Hand, Human, Tumor microenvironment, Liraglutide, ATM, IND, ASCO, Obesity, Patient, Cleavage, MUC, Annual general meeting, CSPC, CB1, Cervical cancer, Biotechnology, Therapy, Insulin resistance

Phase 1 data for CRB-701 (SYS6002) to be presented at ASCO Annual Meeting on June 1, 2024

Key Points: 
  • Phase 1 data for CRB-701 (SYS6002) to be presented at ASCO Annual Meeting on June 1, 2024
    NORWOOD, Mass., May 07, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a precision oncology company with a diversified portfolio, today provided a corporate update and reported financial results for the quarter ended March 31, 2024.
  • We look forward to CSPC’s presentation of updated data at the ASCO 2024 Annual Meeting.
  • During the quarter, we also continued to advance CRB-913 for the treatment of obesity and expect to dose the first patient in Q1 2025.
  • Updated data from this study will be presented by CSPC as a poster at the ASCO 2024 Annual Meeting on June 1, 2024.

FibroGen Reports First Quarter 2024 Financial Results

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月曜日, 5月 6, 2024
Pamrevlumab, Sale, Investment, Peripheral neuropathy, Pancreatic cancer, Neutropenia, RECIST, LAPC, CD46, Weight loss, MD, PSA, Webcast, Growth, IND, ASCO, CKD, Patient, Fatigue, Neoplasm, SAN, AstraZeneca, Anemia, CIA, Interest, Pharmaceutical industry

Expect approval decision for roxadustat in chemotherapy-induced anemia (CIA) in China in the second half of 2024.

Key Points: 
  • Expect approval decision for roxadustat in chemotherapy-induced anemia (CIA) in China in the second half of 2024.
  • Total revenue for the first quarter of 2024 was $55.9 million, as compared to $36.2 million for the first quarter of 2023, an increase of 55% year over year.
  • At March 31, 2024, FibroGen reported $214.7 million in cash - defined as cash, cash equivalents, investments, and accounts receivable.
  • FibroGen will host a conference call and webcast today, Monday, May 6, 2024, at 5:00 PM Eastern Time to discuss financial results and provide a business update.

TIVDAK® (tisotumab vedotin-tftv) Receives U.S. FDA Approval to Treat Recurrent or Metastatic Cervical Cancer

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月曜日, 4月 29, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, PFS, Congress, Pfizer, Peripheral neuropathy, Priority review, Risk, Woman, Food, Progression-free survival, Nausea, Survival, Death, Pneumonitis, Hazard, ESMO, Gynecologic Oncology (journal), OS, Disease, ADC, Patient, PFE, Bleeding, Fatigue, Toxicity, Diagnosis, Constipation, Clinical trial, Mount Sinai Medical Center, Cervical cancer, Nosebleed, Pharmaceutical industry

This FDA action converts the September 2021 accelerated approval of TIVDAK to a full approval.

Key Points: 
  • This FDA action converts the September 2021 accelerated approval of TIVDAK to a full approval.
  • TIVDAK is the first antibody-drug conjugate (ADC) with demonstrated overall survival data to be granted full FDA approval in this patient population.
  • The approval is based on results from the global, randomized, Phase 3 innovaTV 301 clinical trial ( NCT04697628 ), in which TIVDAK met its primary endpoint of overall survival (OS) in patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy.
  • “Treatment options for patients with advanced or recurrent cervical cancer are limited.

FDA Grants Full Approval for TIVDAK® to Treat Recurrent or Metastatic Cervical Cancer

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月曜日, 4月 29, 2024
Biotechnology, FDA, Other Health, Health, General Health, Pharmaceutical, Oncology, Other Science, Research, Science, Clinical Trials, PFS, Congress, Pfizer, Peripheral neuropathy, Priority review, Risk, Woman, Food, Progression-free survival, Nausea, Survival, Death, Pneumonitis, ESMO, Gynecologic Oncology (journal), OS, Disease, Patient, PFE, Bleeding, Fatigue, Toxicity, Constipation, Diagnosis, Inc., Clinical trial, Mount Sinai Medical Center, Cervical cancer, Nosebleed, Pharmaceutical industry

"Recurrent or metastatic cervical cancer is a particularly devastating and mostly incurable disease, and patients are in need of survival-extending treatment options,” said Chris Boshoff, M.D., Ph.D., Chief Oncology Officer, Executive Vice President at Pfizer.

Key Points: 
  • "Recurrent or metastatic cervical cancer is a particularly devastating and mostly incurable disease, and patients are in need of survival-extending treatment options,” said Chris Boshoff, M.D., Ph.D., Chief Oncology Officer, Executive Vice President at Pfizer.
  • Secondary endpoints of progression-free survival (PFS) and confirmed objective response rate (ORR) were also met.
  • Median OS for patients treated with TIVDAK was 11.5 months [95% CI: 9.8-14.9] versus chemotherapy 9.5 months [95% CI: 7.9-10.7].
  • “Treatment options for patients with advanced or recurrent cervical cancer are limited.