Trial of the century

FDA grants Orphan Drug Designation for tasquinimod in myelofibrosis

Retrieved on: 
Wednesday, May 18, 2022
Ruxolitinib, Multiple myeloma, Death, Risk, Fever, Lymphatic system, Spleen, MC, Justicia oncodes, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Infection, Survival, Erasmus, Incidence, Bone marrow failure, Nasdaq, Patient, Erasmus MC, EU, NASDAQ, MF, Acute leukemia, Erythropoietin, Therapy, Degenerative disease, Trial of the century, Research, FDA, Haematopoietic system, JAK, Partnership, Laquinimod, Fibrosis, Biotechnology, III, Anemia, CET, ACTI, CFO, Pancreatic serous cystadenoma, CEO, Pharmaceutical industry

Lund May 18, 2022 - Active Biotech AB (Nasdaq Stockholm: ACTI) today announced that the U.S. Food and Drug Administration (FDA) has granted tasquinimod Orphan Drug Designation for the treatment of myelofibrosis.

Key Points: 
  • Lund May 18, 2022 - Active Biotech AB (Nasdaq Stockholm: ACTI) today announced that the U.S. Food and Drug Administration (FDA) has granted tasquinimod Orphan Drug Designation for the treatment of myelofibrosis.
  • The Orphan Drug Designation awarded by the FDA for tasquinimod in myelofibrosis represents an important step forward for Active Biotech, said Heln Tuvesson, CEO Active Biotech.
  • The FDA Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnoses or prevention of rare diseases or disorders that affects fewer than 200,000 people in the U.S.
  • Active Biotech and Erasmus MC have initiated a research collaboration with tasquinimod in myelofibrosis, that includes preclinical studies as well as a clinical proof of concept study in patients with myelofibrosis.

Immatics Announces First Patient Treated with ACTengine® IMA203 TCR-T in Combination with Checkpoint Inhibitor Opdivo® (nivolumab) in Patients with Advanced Solid Tumors

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Wednesday, May 18, 2022
Engineering, University of Texas Health Science Center at Houston, Patient, CD4, NASDAQ, PD-1, RECIST, Clinical trial, Nature, Bristol Myers Squibb, Trial of the century, TCR, Cancer Prevention and Research Institute of Texas, YE, PRAME, Terminology, Safety, Neoplasm, Cancer prevention, Forward-looking statement, Nivolumab, Protocol, Adoptive cell transfer, Research institute, LinkedIn, Twitter, SEC, Cancer, Evelyn, Melanoma, Pharmaceutical industry, Vaccine, Instagram

This cohort will evaluate Immatics TCR-engineered cell therapy (TCR-T) approach ACTengine IMA203 targeting an HLA-A*02-presented peptide derived from PRAME, in combination with Bristol Myers Squibbs PD-1 checkpoint inhibitor nivolumab, in patients with advanced solid tumors.

Key Points: 
  • This cohort will evaluate Immatics TCR-engineered cell therapy (TCR-T) approach ACTengine IMA203 targeting an HLA-A*02-presented peptide derived from PRAME, in combination with Bristol Myers Squibbs PD-1 checkpoint inhibitor nivolumab, in patients with advanced solid tumors.
  • We are excited to elucidate how the combination with an immune checkpoint inhibitor could enhance the potency of our engineered IMA203 T cells.
  • According to the clinical trial protocol for ACTengine IMA203, nivolumab will be administered at regular intervals following IMA203 treatment.
  • The combination treatment of IMA203 and nivolumab is part of Immatics' strategy to realize the full clinical potential of IMA203 TCR-T targeting PRAME.

TULSA-PRO® Was Front and Center at AUA2022

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Tuesday, May 17, 2022
Department, Physician, Education, Software, University of Texas Southwestern Medical Center, Company, Annual general meeting, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Uterine fibroid, Hyperthermia, American Urological Association, Hematuria, National Medical Products Administration, Susceptibility weighted imaging, Patient, MRI, SWI, NASDAQ, ADC, BPH, Bone, Quality of life, Prostate, AMA, Benign prostatic hyperplasia, CE, Trial of the century, TSX, Humanitarian Device Exemption, DWI, FDA, Urology, Prostate cancer, AUA, Man, University, Technology, Risk, LUTS, Rectum, Diffusion, Health Canada, Plenary session, Turku University, Phrase, Growth, Urethra, Medical Corps (United States Army), GLOBE, Medical imaging, Pharmaceutical industry, Profound Pharma

Of particular note, Kenneth A. Goldberg, M.D., an Assistant Professor in the Department of Urology at UT Southwestern Medical Center, performed a Semi-Live TULSA Procedure during the afternoon Plenary Session on May 13th.

Key Points: 
  • Of particular note, Kenneth A. Goldberg, M.D., an Assistant Professor in the Department of Urology at UT Southwestern Medical Center, performed a Semi-Live TULSA Procedure during the afternoon Plenary Session on May 13th.
  • We are extremely encouraged by the positive feedback we received at this event, which adds to the momentum of Profounds ongoing commercialization strategy for TULSA-PRO.
  • The study reported 6-month improvement in patient quality of life, LUTS, sexual function and uroflowmetry, with all men discontinuing their BPH medication.
  • Profound is a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue.

Sorrento’s License Partner, Lee’s Pharm, Announces Full Enrollment of 498 Patients in a Phase III Trial of Socazolimab (Anti-PD-L1 Antibody) for First-Line Treatment of Extensive-Stage Small-Cell Lung Cancer (ES-SCLC)

Retrieved on: 
Tuesday, May 17, 2022
U.S. Securities and Exchange Commission, Carboplatin, Dermatology, Antibody, Review, Center, Autoimmune disease, Cholangiocarcinoma, Risk, NDA, TRPV1, Private Securities Litigation Reform Act, Cancer, Annual report, Squamous cell carcinoma, Pain, Phase, Therapy, Clinical trial, Degenerative disease, Marketing, SAN, Obstetrics, Osteoarthritis, GLOBE, Death, Company, Survival, Postherpetic neuralgia, Vaccine, Pharming, Health, Trial of the century, FDA, COF, Human, Ovarian cancer, Maintenance, RTX, Sciatica, Security (finance), Etoposide, Patient, PHN, PD-1, ADA, Forward-looking statement, NMPA, Glioblastoma, Safety, Drug development, ADCC, Pharmaceutical industry, Fine chemical, Generic drug, COVID-19

COF has completed the patient enrollment (498 patients) for a Phase III, multicenter, randomized, double blinded, placebo-controlled clinical trial of Socazolimab combined with chemotherapy in the first-line treatment of extensive-stage small-cell lung cancer (ES-SCLC).

Key Points: 
  • COF has completed the patient enrollment (498 patients) for a Phase III, multicenter, randomized, double blinded, placebo-controlled clinical trial of Socazolimab combined with chemotherapy in the first-line treatment of extensive-stage small-cell lung cancer (ES-SCLC).
  • Socazolimab is an in-licensed product from Sorrento for the Peoples Republic of China, Hong Kong, Macau and Taiwan.
  • RTX has been cleared for a Phase II trial for intractable pain associated with cancer and a Phase II trial in osteoarthritis patients.
  • ZTlido is a registered trademark owned by Scilex Pharmaceuticals Inc.
    All other trademarks are the property of their respective owners.

Prosperdtx Launches Strategic Collaboration With Health Equity Researchers and Seqster to Improve Health Equity for Cancer Patients

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Wednesday, May 18, 2022
Nanotechnology, Other Science, Pharmaceutical, Research, Insurance, Oncology, Software, Finance, Hardware, Hospitals, Data Management, Professional Services, Science, Technology, Managed Care, Biotechnology, Surgery, Health, Assistant, Education, DNA, Trial of the century, Research, Social media, Lucile Adams-Campbell, Healthcare disparity in Massachusetts, Patient, Survivor, Health, Office, List of life sciences, Associate, Patient engagement in Canada, Pharmacy, Laika (EHR testing framework), Instagram, Digital technology, YouTube, Communication, Hospital, Digital health, Forward-looking statement, Therapy, LinkedIn, Twitter, Cancer, Health equity, Office of Minority Health, District, CEO, Pharmaceutical industry, Medical imaging, Asian Americans, Facebook

Our collaboration with Seqster will enable us to demonstrate how Prosperdtxs digital health platform can help cancer patients live better lives with improved and cost-effective health outcomes.

Key Points: 
  • Our collaboration with Seqster will enable us to demonstrate how Prosperdtxs digital health platform can help cancer patients live better lives with improved and cost-effective health outcomes.
  • Seqsters Operating System will enable Prosperdtx to deliver precision cancer care to cancer patients in real-time, said Joseph Swiader, co-founder and CEO of Prosperdtx.
  • Prosperdtx is maximizing the continuity of cancer care so that patients can live longer, better lives while reducing the cost of healthcare.
  • Seqster has nationwide coverage of EHRs from hospitals and medical groups, genomic DNA, wearables, pharmacy, and social determinants of health data.

Adaptive Phage Therapeutics Announces First Patient Dosed in the DANCE Trial, a Phase 1/2 Study Evaluating APT Phage Bank in Diabetic Foot Osteomyelitis

Retrieved on: 
Wednesday, May 18, 2022
Science, Biotechnology, Research, Pharmaceutical, Health, Diabetes, Infectious Diseases, Clinical Trials, Diabetes, Risk, PST, Infection, DFO, MD, American Diabetes Association, Multimedia, Patient, Phage therapy, Therapy, Trial of the century, NIH, FDA, United States Department of Defense, Time, APT, Osteomyelitis, Safety, Technology, National, Amputation, Investigational New Drug, Pharmaceutical industry

View the full release here: https://www.businesswire.com/news/home/20220518005275/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20220518005275/en/
    Vial of phage from APTs phage bank for evaluation in treatment of bacterial infections.
  • Phages from the APT phage bank are precision-matched to the patients infections through a proprietary phage susceptibility test (PST) that APT has teamed with Mayo Clinic Laboratories to commercialize on a global scale.
  • Adaptive Phage Therapeutics (APT) is a clinical-stage company advancing therapies to treat multi-drug resistant infections.
  • APT has ongoing clinical trials to address substantial unmet patient needs in Prosthetic Joint Infection (PJI) and Diabetic Foot Osteomyelitis (DFO).

Humanetics Corporation Expands Long-Haul COVID-19 Trial to Additional Sites

Retrieved on: 
Wednesday, May 18, 2022
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Humanetics Corporation (Humanetics) has added two additional clinical sites to its long-haul COVID-19 study, which is focused on patients who were treated for severe COVID-19 and face the possible risk that their respiratory complications will lead to long-term impairment of lung function.

Key Points: 
  • Humanetics Corporation (Humanetics) has added two additional clinical sites to its long-haul COVID-19 study, which is focused on patients who were treated for severe COVID-19 and face the possible risk that their respiratory complications will lead to long-term impairment of lung function.
  • These sites join existing sites at NYU Langone and the Houston Methodist Research Institute.
  • The clinical study is designed to evaluate the ability of Humanetics new drug, BIO 300, to mitigate long-term pulmonary damage.
  • The primary endpoint of the trial is 12 weeks after the start of dosing and patients will be followed for one year.

Seelos Therapeutics Receives a Notice of Allowance in the U.S. for an Additional Patent for SLS-007

Retrieved on: 
Wednesday, May 18, 2022
Risk, Lewy body, Company, MDD, Patent, Parkinson's disease, Private Securities Litigation Reform Act, Sanfilippo syndrome, U.S. Securities and Exchange Commission, Organic acid, Multiple system atrophy, Nasdaq, Patient, SCA, Alpha-synuclein, Disorder, Psychiatry, Therapy, Nature, Degenerative disease, Amyotrophic lateral sclerosis, COVID-19, Movement disorders, Trial of the century, Research, Neurodegeneration, CNS, Peptide, AAV, Alzheimer's disease, Lewy, Spinocerebellar ataxia, Central nervous system, Major depressive disorder, Pathology, ASIB, USPTO, ALS, Annual report, Pharmaceutical industry, Behavior, PD

Seelos is currently delivering SLS-007 via an adeno-associated virus (AAV) in a preclinical study designed to establish the in vivo pharmacokinetic and pharmacodynamic profiles and target engagement.

Key Points: 
  • Seelos is currently delivering SLS-007 via an adeno-associated virus (AAV) in a preclinical study designed to establish the in vivo pharmacokinetic and pharmacodynamic profiles and target engagement.
  • SLS-007 is a family of rationally designed peptide inhibitors that target the non-amyloid component core (NACore) of -synuclein to inhibit protein aggregation in patients with PD.
  • Recent in vitro and cell culture research have shown that SLS-007 has the potential to stop the propagation and seeding of -synuclein aggregates.
  • For more information, please visit our website: http://seelostherapeutics.com , the content of which is not incorporated herein by reference.

BioVaxys Confirms First Clinical Site and Principal Investigators for Ovarian Cancer Vaccine Trial and Enters into Second Tumor Cell Supply Agreement

Retrieved on: 
Wednesday, May 18, 2022
Cancer, Hapten, Disease, HCL, Ovarian cancer, European Society of Gynaecological Oncology, Center, EMA, Standard of care, Immune system, FRA, OTCQB, University Hospital Center Dr Dragiša Mišović, GMP, Woman, Clinical trial, COVID-19, CSE, III, Hospital, Neoplasm, Company, Survival, Peritoneum, Doctor of Philosophy, Vaccine, Trial of the century, FDA, Obstetrics, Biotechnology, Good, Toxicity, CTA, European Medicines Agency, Heart, Hospices Civils de Lyon, Protein, Severe acute respiratory syndrome coronavirus 2, Cryopreservation, Patient, International Journal of Gynecology & Obstetrics, National Cancer Institute, IND, European Society for Clinical Investigation, Prognosis, Head, ProCare, Usha Menon, Pharmaceutical industry, Medical imaging, Lyon Metropolis, MD, EU, BC

HCL is a public hospital and France's second University Hospital Center, and a premier site for clinical studies in the EU.

Key Points: 
  • HCL is a public hospital and France's second University Hospital Center, and a premier site for clinical studies in the EU.
  • Benot You, MD, PhD, of HCL who are planned Clinical Investigators for the Phase I study of BVX-0918.
  • BioVaxys is preparing to file a Clinical Trial Application ("CTA") with the European Medicines Agency ("EMA") later in 2022.
  • Access to surgically removed ovarian cancer tumor cells is a critical step enabling BioVaxys to validate the manufacturing process for BVX-0918.

BioVaxys Confirms First Clinical Site and Principal Investigators for Ovarian Cancer Vaccine Trial and Enters into Second Tumor Cell Supply Agreement

Retrieved on: 
Wednesday, May 18, 2022
Cancer, Hapten, Disease, HCL, Ovarian cancer, European Society of Gynaecological Oncology, Center, EMA, Standard of care, Immune system, FRA, OTCQB, University Hospital Center Dr Dragiša Mišović, GMP, Woman, Clinical trial, COVID-19, CSE, III, Hospital, Neoplasm, Company, Survival, Peritoneum, Doctor of Philosophy, Vaccine, Trial of the century, FDA, Obstetrics, Biotechnology, Good, Toxicity, CTA, European Medicines Agency, Heart, Hospices Civils de Lyon, Protein, Severe acute respiratory syndrome coronavirus 2, Cryopreservation, Patient, International Journal of Gynecology & Obstetrics, National Cancer Institute, IND, European Society for Clinical Investigation, Prognosis, Head, ProCare, Usha Menon, Pharmaceutical industry, Medical imaging, Lyon Metropolis, MD, EU, BC

HCL is a public hospital and France's second University Hospital Center, and a premier site for clinical studies in the EU.

Key Points: 
  • HCL is a public hospital and France's second University Hospital Center, and a premier site for clinical studies in the EU.
  • Benot You, MD, PhD, of HCL who are planned Clinical Investigators for the Phase I study of BVX-0918.
  • BioVaxys is preparing to file a Clinical Trial Application ("CTA") with the European Medicines Agency ("EMA") later in 2022.
  • Access to surgically removed ovarian cancer tumor cells is a critical step enabling BioVaxys to validate the manufacturing process for BVX-0918.