Neuropathic pain

Acasti to Host Conference Call on Tuesday, January 10, 2023 to Discuss Results from Recent Phase 1 PK Studies for GTX-101 and GTX-102 That Met All Outcome Measures

Retrieved on: 
Thursday, January 5, 2023
Bupivacaine, Calendar, Betamethasone, Pain, Pharmacokinetics, Telephone, Ataxia–telangiectasia, PK, Neuropathic pain, TSX, ACST, Trial of the century, Nerve Damage, A-T, Safety, FDA, Human, Pharmaceutical industry, Internet service provider, Postherpetic neuralgia

ET to review the recently reported preliminary topline results from two separate Phase 1 pharmacokinetic (PK) studies for GTX-101 and GTX-102.

Key Points: 
  • ET to review the recently reported preliminary topline results from two separate Phase 1 pharmacokinetic (PK) studies for GTX-101 and GTX-102.
  • Both studies successfully met all target outcome measures.
  • The conference call will be available via telephone by dialing toll free 844-836-8745 for U.S. callers or +1 412-317-6797 for international callers.
  • On December 28, 2022, Acasti announced that the preliminary topline results of the pharmacokinetic (PK) bridging study for GTX-102 met all primary outcome measures.

OKYO Pharma Limited - Interim Results for the Six Months Ending 30 September 2022

Retrieved on: 
Friday, December 30, 2022
Gabapentin, Peripheral neuropathy, MD, DED, Neuropathic pain, EU, File, NOW, AS, MA, Patient, Duane syndrome, Tufts University School of Medicine, FDA, IND, LSE, Tufts University School of Dental Medicine, OF, THIS, Pharmaceutical industry, Ophthalmology

LONDON and NEW YORK, Dec. 30, 2022 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (LSE: OKYO, NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical company developing OK-101 to treat Dry Eye Disease (DED) to address the significant unmet need in this multi-billion-dollar market, today announces its interim results for the six months ended 30 September 2022.

Key Points: 
  • LONDON and NEW YORK, Dec. 30, 2022 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (LSE: OKYO, NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical company developing OK-101 to treat Dry Eye Disease (DED) to address the significant unmet need in this multi-billion-dollar market, today announces its interim results for the six months ended 30 September 2022.
  • After considerable effort over the past 18 months, the Group announced on 21 November 2022 the filing of an IND on OK-101 with FDA to treat DED patients.
  • The Phase 2 trial is expected to be completed in 6-9 months from enrollment of the first patient.
  • UPON THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE INFORMATION (AS DEFINED IN UK MAR) IS NOW CONSIDERED TO BE IN THE PUBLIC DOMAIN.

Acasti Pharma Announces Preliminary Topline Results Met All Primary Outcome Measures in the Single Dose Pharmacokinetic Study for GTX-101, the Company’s Drug Candidate for the Treatment of Postherpetic Neuralgia (PHN)

Retrieved on: 
Thursday, December 22, 2022
Standard of care, Bupivacaine, Calendar, Betamethasone, Pain, Blood, Pharmacokinetics, Gabapentin, Lidocaine, PHN, Ataxia–telangiectasia, PK, Neuropathic pain, Hydrogen chloride, TSX, Tmax, ACST, Skin, NDA, Toxicity, Risk, Trial of the century, Irritation, Nerve Damage, Patient, Plasma, Type, A-T, AUC, Safety, Physician, FDA, Headache, Human, Hypoesthesia, Postherpetic neuralgia, Cmax, Pharmaceutical industry, Risk management, Generic drug

The final clinical study report is anticipated to be received by the Company in the first half of 2023.

Key Points: 
  • The final clinical study report is anticipated to be received by the Company in the first half of 2023.
  • The potential benefits of GTX-101 could include faster onset of action and a longer duration of pain relief as compared to the lidocaine patch.
  • The study enrolled 48 healthy adult subjects (24 males/24 females, mean age = 36 years), in 12 subjects per cohort.
  • Following GTX-101 topical application: headache (3%) and numbness (3%) at the sprayed area, and
    In conclusion, this Single Dose PK study was conducted successfully, and it achieved all its primary outcome measures.

Lexicon Announces Topline Results From Phase 2 Proof-of-Concept Study of LX9211 in Postherpetic Neuralgia

Retrieved on: 
Wednesday, December 21, 2022
Death, Dizziness, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Neuropathic pain, Diabetic neuropathy, Week, Patient, Postherpetic neuralgia, Fast Track, Pharmaceutical industry

THE WOODLANDS, Texas, Dec. 21, 2022 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced topline results of RELIEF-PHN-1, its Phase 2 proof-of-concept study of LX9211 in postherpetic neuralgia. LX9211 achieved a reduction in average daily pain score (ADPS) of 2.42 from baseline at week 6 compared to a reduction of 1.62 in the placebo arm, with a placebo adjusted difference of 0.80 (p=0.12). Although these results did not reach statistical significance on the primary endpoint of the study, overall study results demonstrated clear evidence of effect. Separation of LX9211 from placebo on ADPS was seen at week 1 and maintained consistently thereafter, with an average placebo adjusted reduction over the 6 Week dosing period of 0.80 (p=0.03).

Key Points: 
  • Although these results did not reach statistical significance on the primary endpoint of the study, overall study results demonstrated clear evidence of effect.
  • “The RELIEF-PHN-1 study results are broadly consistent with the results achieved in our positive Phase 2 study of LX9211 in painful diabetic neuropathy (RELIEF-DPN-1) which enrolled over 300 patients.
  • LX9211 achieved significant and consistent benefits in the treatment of painful diabetic neuropathy in the RELIEF-DPN-1 study, from which full results were presented in November 2022.
  • LX9211 has received Fast Track designation from the U.S. Food and Drug Administration for development in diabetic peripheral neuropathic pain.

Y-mAbs Announces Pipeline Update

Retrieved on: 
Wednesday, December 14, 2022
Squamous cell carcinoma, Neoplasm, Annual report, Sarcoma, Interim, Osteosarcoma, Security (finance), Marketing, MRCP, SVP, B7-H3, Growth, MBA, Research, MSK, COVID-19, DCH, FDA, Safety, Cancer, Bone marrow, Neuropathic pain, GD2, Melanoma, All India Mahila Congress, Granulocyte-macrophage colony-stimulating factor, MBBS, Cardiac arrest, Neurotoxicity, Transverse myelitis, Patient, Failure, Antibody, Government, Memorial Sloan Kettering Cancer Center, Anaphylaxis, Therapy, Vaccine, Pharmaceutical industry

Investors, analysts, members of the media and the public may access the event via a live webcast .

Key Points: 
  • Investors, analysts, members of the media and the public may access the event via a live webcast .
  • The presentation materials can be found on the Company’s website under the Presentations tab under the heading For Investors.
  • Dr. Rajah, will present an update on DANYELZA® (naxitamab-gqgk), including potential label expansion into osteosarcoma, and a planned multicenter Phase 2 trial in patients with newly diagnosed high-risk neuroblastoma.
  • The Company’s broad and advanced product pipeline includes one FDA-approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and one product candidate at the registration-stage, OMBLASTYS® (omburtamab), which targets tumors that express B7-H3.

Y-mAbs’ DANYELZA® (naxitamab-gqgk) for the Treatment of High-Risk Neuroblastoma Approved in China

Retrieved on: 
Thursday, December 8, 2022
Granulocyte-macrophage colony-stimulating factor, Sarcoma, Neoplasm, Annual report, Failure, Interim, Government, Marketing, FDA, Cardiac arrest, National Medical Products Administration, Safety, Cancer, Bone marrow, Memorial Sloan Kettering Cancer Center, Neurotoxicity, Neuropathic pain, B7-H3, Risk, GD2, Growth, Anaphylaxis, Transverse myelitis, Research, Therapy, MSK, Holding, COVID-19, Patient, Vaccine, Pharmaceutical industry

DANYELZA will be marketed in China by Y-mAbs’ partner SciClone Pharmaceuticals (Holdings) Limited (“SciClone Pharmaceuticals”).

Key Points: 
  • DANYELZA will be marketed in China by Y-mAbs’ partner SciClone Pharmaceuticals (Holdings) Limited (“SciClone Pharmaceuticals”).
  • DANYELZA is a humanized, monoclonal antibody that targets the ganglioside GD2, which is highly expressed in various neuroectoderm-derived tumors and sarcomas.
  • DANYELZA is administered to patients three times in a week in an outpatient setting and the treatment is repeated every four weeks.
  • “Today is an important day for children living with refractory/relapsed high-risk neuroblastoma in China.

Y-mAbs to Host Annual Research and Development Day in New York

Retrieved on: 
Tuesday, December 6, 2022
Granulocyte-macrophage colony-stimulating factor, Neoplasm, Annual report, Research, Failure, Interim, Osteosarcoma, MBBS, Government, Marketing, DCH, FDA, Cardiac arrest, PRV, Safety, Sale, Memorial Sloan Kettering Cancer Center, Bone marrow, MRCP, Neurotoxicity, SVP, Neuropathic pain, B7-H3, GD2, Growth, Anaphylaxis, MBA, Transverse myelitis, Therapy, MSK, COVID-19, Development, Patient, Pharmaceutical industry

NEW YORK, Dec. 06, 2022 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company today announced that it will host its annual Research and Development Day in New York, NY on December 14, 2022, at 9:00 am ET.

Key Points: 
  • NEW YORK, Dec. 06, 2022 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company today announced that it will host its annual Research and Development Day in New York, NY on December 14, 2022, at 9:00 am ET.
  • The event will feature presentations of the Company, its clinical development, and advanced product pipeline.
  • Thomas Gad (Founder, President, and Interim Chief Executive Officer at Y-mAbs Therapeutics) will give a corporate presentation.
  • Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic cancer products.

Exicure, Inc. Announces Termination of AbbVie and Ipsen Collaboration Agreements

Retrieved on: 
Wednesday, December 14, 2022
Biotechnology, Health, Neurology, Clinical Trials, Security (finance), Partnership, Neurodegeneration, SCN9A, AbbVie, Angelman syndrome, Ipsen, Neuropathic pain, Pharmaceutical industry

Exicure, Inc. (NASDAQ: XCUR) an early-stage biotechnology company historically focused on developing nucleic acid therapies targeting ribonucleic acid against validated targets, today announced the termination of its collaboration agreements with AbbVie, Inc. (AbbVie) and Ipsen BioPharm Limited (Ipsen).

Key Points: 
  • Exicure, Inc. (NASDAQ: XCUR) an early-stage biotechnology company historically focused on developing nucleic acid therapies targeting ribonucleic acid against validated targets, today announced the termination of its collaboration agreements with AbbVie, Inc. (AbbVie) and Ipsen BioPharm Limited (Ipsen).
  • Through separate agreements with AbbVie and Ipsen, Exicure was collaboratively advancing specified discovery programs in hair loss disorders and rare neurodegenerative disorders, respectively.
  • They were both tremendous companies to be associated with and extremely helpful and collaborative in developing and advancing the terminated discovery programs.
  • In addition to these actions, Exicure is exploring strategic alternatives focused on maximizing stockholder value, stated Matthias Schroff, Chief Executive Officer, Exicure.

Camizestrant Significantly Delayed Disease Progression in Advanced ER-Positive Breast Cancer, Adding at Least 3.5 Months Benefit Versus FASLODEX® (fulvestrant)

Retrieved on: 
Thursday, December 8, 2022
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, QT, Hypersensitivity, ESR1, Hypocalcemia, Peripheral neuropathy, Anemia, Angioedema, Headache, AstraZeneca, Syncope, Woman, Duane syndrome, Hives, Xeroderma, Paced Auditory Serial Addition Test, Leukopenia, Sciatic nerve, Risk, Indigestion, Thrombocytopenia, Lung, Rash, Myalgia, Liver, Fatigue, Pain, Back pain, US Foods, Photopsia, Birth, Immunoassay, Constipation, Hair, Infant, Infection, Food, Neutropenia, Bleeding, Bradycardia, Pregnancy, Dysgeusia, Cough, Diarrhea, Estradiol, Itch, PFS, Tears, Neuralgia, CI, Purging disorder, Grade, Mutation, Xerostomia, Vertigo, Patient, Fulvestrant, Nausea, Vomiting, Incidence, Aromatase, Breathe Me, Arthralgia, Erythema, Bone pain, Stomatitis, Weakness, Sciatica, Fetus, Neuropathic pain, Appetite, Pharmaceutical industry, Vaccine, Dietary supplement, Fever

AstraZeneca has a broad clinical development program for camizestrant in advanced breast cancer.

Key Points: 
  • AstraZeneca has a broad clinical development program for camizestrant in advanced breast cancer.
  • Advise women of reproductive potential to use effective contraception during FASLODEX treatment and for 1 year after the last dose.
  • SERENA-2 is a randomized, open-label, parallel group, multicenter Phase II trial evaluating camizestrant at several dose levels compared to FASLODEX in advanced ER-positive, HER2-negative breast cancer.
  • The primary endpoints are PFS defined by response evaluation criteria in solid tumors (RECIST) version 1.1 for 75mg camizestrant versus FASLODEX and for 150mg camizestrant versus FASLODEX.

Capivasertib Plus FASLODEX® (fulvestrant) Reduced the Risk of Disease Progression or Death by 40% Versus FASLODEX in Advanced HR-Positive Breast Cancer

Retrieved on: 
Thursday, December 8, 2022
Oncology, Health, General Health, Clinical Trials, Pharmaceutical, Cardiology, Biotechnology, QT, Indigestion, Thrombocytopenia, ORR, Hypersensitivity, Neutropenia, Rash, Bleeding, Xerostomia, Pregnancy, Dysgeusia, Cough, Hypocalcemia, Vertigo, Patient, Diarrhea, Peripheral neuropathy, Estradiol, OS, Myalgia, Anemia, Liver, Angioedema, Itch, Nausea, Fulvestrant, Neuralgia, Headache, Tears, Fatigue, Vomiting, Syncope, Pain, Back pain, Appetite, Breathe Me, Woman, Incidence, Arthralgia, Erythema, Bone pain, Birth, Stomatitis, Duane syndrome, Hives, Immunoassay, Constipation, Safety, Purging disorder, Hair, Xeroderma, Infant, Sciatica, Weakness, Paced Auditory Serial Addition Test, Infection, Fetus, Leukopenia, AES, Neuropathic pain, Sciatic nerve, Risk, Medical imaging, Vaccine, Dietary supplement, Fever

CAPItello-291 is evaluating the efficacy of capivasertib in combination with FASLODEX versus placebo plus FASLODEX for the treatment of locally advanced (inoperable) or metastatic HR-positive, HER2-low or negative breast cancer.

Key Points: 
  • CAPItello-291 is evaluating the efficacy of capivasertib in combination with FASLODEX versus placebo plus FASLODEX for the treatment of locally advanced (inoperable) or metastatic HR-positive, HER2-low or negative breast cancer.
  • Capivasertib is an investigational oral treatment currently in Phase III trials for the treatment of multiple subtypes of breast cancer, prostate cancer and a Phase II trial for hematologic malignancies.
  • Fulvestrant plus capivasertib versus placebo after relapse or progression on an aromatase inhibitor in metastatic, oestrogen receptor-positive, HER2-negative breast cancer (FAKTION).
  • Comparative Overall Survival of CDK4/6 Inhibitors Plus Endocrine Therapy vs. Endocrine Therapy Alone for Hormone receptor-positive, HER2-negative metastatic breast cancer.