A Multicenter, Randomized, Phase 3 Study to Assess the Efficacy and Safety of INtratumorally Administered INT230-6 (SHAO, VINblastine, CIsplatin) Compared With US Standard of Care in Adults With Locally Recurrent, InoperaBLE, or Metastatic Soft Tissue Sarcomas (INVINCIBLE-3)

To compare Overall Survival (OS) for INT230-6 vs United States (US) Standard of Care (SOC) in participants with unresectable or metastatic liposarcoma, undifferentiated pleomorphic sarcoma or leiomyosarcoma who have disease progression prior to study enrollment following no more than 2 standard therapies, which must have included an anthracycline-based regimen, unless contraindicated, and then a maximum of 1 additional regimen.

开始日期2024-06-28

申办/合作机构

Intensity Therapeutics, Inc.

[+1]

NCT06050122 / Recruiting临床3期

A Multicenter, Randomized, Double Blind, Vehicle-controlled, Phase 3 Efficacy and Safety Study of Patidegib Gel 2% for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects With Gorlin Syndrome

The aim of this clinical study is to find out how well Patidegib Gel 2% works in preventing new basal cell carcinomas (BCCs) developing on the face of adults with Gorlin syndrome, and how safe Patidegib Gel 2% is to use.
Participants will apply either Patidegib Gel 2% or a Vehicle Gel (with no active drug substance) to their face twice a day for a year (12 months). The number of new BCCs on the face will be compared between participants who used Patidegib Gel 2% or Vehicle Gel after 12 months.

开始日期2024-03-17

申办/合作机构

Sol-Gel Technologies Ltd.

[+1]

NCT06059963 / RecruitingN/A

A Prospective, Multi-center, Observational Study for Signal-C Test Evaluation

To evaluate the performance characteristics of Signal-C™ a plasma circulating free-DNA test, to detect colorectal cancer and advanced precancerous lesions (APL) in an average risk screening population for 45 and over.

开始日期2024-01-18

申办/合作机构

Universal Diagnostics SA

[+2]

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2005-05-01·The Clinical Journal of Pain3区 · 医学

The Time to Onset and Overall Analgesic Efficacy of Rofecoxib 50 mg

3区 · 医学

Article

作者: Geba, Gregory P ; Mehlisch, Donald R ; Polis, Adam B ; Malmstrom, Kerstin ; Krupa, David ; Desjardins, Paul J ; Petruschke, Richard A ; Chang, David J

OBJECTIVETo determine the time to onset of analgesia of rofecoxib based on a patient-level meta-analysis of randomized, placebo-controlled, postoperative oral surgery pain studies.METHODSA search on MEDLINE and of Merck data on file was conducted to identify studies that met the inclusion criteria. Meta-analysis inclusion criteria required that patients were treated with a single oral dose of rofecoxib 50 mg when they experienced moderate or severe pain after surgical extraction of > or = 2 third molars; study design involved patient randomization, double-blinding, and matching placebo, and onset data from individual patients were available. The meta-analysis of time to onset also required that studies used the two-stopwatch method. Eleven studies fulfilled the onset criteria and included patients who received a single dose of rofecoxib 50 mg (N = 1220) or placebo (N = 483). These studies were analyzed to determine time to onset of analgesia, time to perceptible pain relief, percentage of patients achieving onset of analgesia, and duration of analgesia. Six of the 11 studies included a nonselective nonsteroidal anti-inflammatory drug (N = 303) and were included in the onset meta-analysis for comparison. The meta-analysis of overall efficacy also required that data on total pain relief scores over 8 hours were available. Over-all effectiveness of analgesia was based on analysis of 13 studies involving 1330 rofecoxib patients and 570 placebo patients on the endpoints of total pain relief scores over 8 hours and patient global assessment of response to therapy at 24 hours. Eight of the 13 studies with a nonselective nonsteroidal anti-inflammatory drug comparator (N = 391) were included for the efficacy meta-analysis.RESULTSPatient demographics and baseline characteristics were similar across treatment groups in each study. Median time to onset of analgesia for rofecoxib was 34 minutes (95% CI, 31-38 minutes), significantly faster than placebo, which did not achieve onset within the 4 hours the assessment was conducted (P < 0.001). Duration of analgesia for rofecoxib 50 mg was > 24 hours. Rofecoxib achieved a greater mean total pain relief score over 8 hours than placebo (17.4 versus 4.4; P < 0.001) and a greater patient response rate on patient global assessment of response to therapy at 24 hours than placebo (73% versus 16%; P < 0.001). Outcomes were similar between the rofecoxib group and the nonselective nonsteroidal anti-inflammatory drug group.CONCLUSIONIn this meta-analysis of over 1200 rofecoxib-treated patients, a single dose of rofecoxib 50 mg demonstrated a rapid onset of analgesia in approximately half an hour combined with sustained effectiveness, supporting its use as a treatment of acute pain.

2004-06-01·Current Medical Research and Opinion4区 · 医学

Comparison of rofecoxib and a multidose oxycodone/acetaminophen regimen for the treatment of acute pain following oral surgery: a randomized controlled trial

4区 · 医学

Article

作者: Petruschke, Richard A. ; Bird, Steven R. ; Geba, Gregory P. ; Chen, Erluo ; Chang, David J. ; Desjardins, Paul J. ; Black, Peter

OBJECTIVETo compare the efficacy of a single dose of rofecoxib 50 mg with a single dose of oxycodone/acetaminophen 10/650 mg over 6 h as well as with a multidose regimen of oxycodone/acetaminophen 10/650 mg followed by oxycodone/acetaminophen 5/325 mg over 24 h.RESEARCH DESIGN AND METHODSIn this double-blind, randomized, two-phase study, patients with moderate to severe pain after surgical extraction of >or= 2 third molars, including one mandibular impaction, were treated with rofecoxib 50 mg, oxycodone/acetaminophen 10/650 mg (singledose phase) followed by 5/325 mg every 6h as needed (multidose phase), or placebo. Patients rated their pain relief and intensity at 18 time points over 24 h. Efficacy was measured over 6 and 24 h by total pain relief (TOPAR), sum of pain intensity difference (SPID), and patient global assessment of response to therapy (PGART). Primary endpoint for the single dose comparison was TOPAR over 6 h; SPID was the key 24-h endpoint. Onset of analgesic effect, peak analgesic single dose of oxycodone/acetaminophen. effect, and duration of analgesic effect were also evaluated. Adverse experiences were recorded.RESULTS271 patients were randomized to treatment with rofecoxib (n = 121), oxycodone/acetaminophen (n = 120), or placebo (n = 30). For the single dose comparison, rofecoxib-treated patients achieved pain relief at least as effective as oxycodone/acetaminophentreated patients as assessed by TOPAR6 (12.9 vs 11.3, 95% CI on difference = [-0.1, 3.2], p = 0.059). Patients also rated a single dose of rofecoxib as at least as effective as multidose oxycodone/acetaminophen over 24 h on SPID24 (21.9 vs 18.1, 95% CI on difference = [-1.0, 8.8], p = 0.122). Patients treated with oxycodone/ acetaminophen had a shorter time to onset of analgesia than patients treated with rofecoxib (24 vs 35 min, p < 0.05). Patients in the active treatment groups achieved similar peak effects during the single-dose phase. Individuals treated with rofecoxib demonstrated a longer duration of analgesic effect than those treated with a Patients on active treatment demonstrated better efficacy than patients on placebo on these prespecified endpoints (p < 0.001 for both comparisons). Fewer rofecoxib than oxycodone/acetaminophen patients experienced adverse events (47.9 vs 75.8%, p < 0.001), including nausea (19.0 vs 42.5%, p < 0.001), vomiting (9.9 vs 24.2%, p < 0.01), and dizziness (7.4 vs 31.7%, p < 0.001).CONCLUSIONPatients treated with a single dose of rofecoxib 50 mg achieved an overall analgesic effect at least as effective as patients treated with a single-dose of oxycodone/acetaminophen 10/650 mg over 6 h and multidose oxycodone/acetaminophen over 24 h, with fewer adverse experiences of nausea (p < 0.001), vomiting (p < 0.01), and dizziness (p < 0.001).

2004-05-01·Journal of the American Podiatric Medical Association4区 · 医学

Analgesic Efficacy of Preoperative Parecoxib Sodium in an Orthopedic Pain Model

4区 · 医学

Article

作者: Traylor, Louise ; Hubbard, Richard C. ; Desjardins, Paul J.

The efficacy and safety of preoperative intravenous administration of parecoxib sodium, a novel parenteral prodrug of a cyclooxygenase-2 selective inhibitor, in treating postoperative pain resulting from bunionectomy were evaluated in 50 patients who were part of a larger cohort of orthopedic and podiatric patients. Following bunionectomy, the median time to rescue medication (survival analysis) was 4 hours 18 min (95% confidence interval, 3 hours 4 min to 4 hours 37 min) in the placebo group, 7 hours 5 min (95% confidence interval, 3 hours 20 min to >24 hours) in the 20-mg parecoxib sodium group, and 10 hours 43 min (95% confidence interval, 4 hours 42 min to 14 hours 7 min) in the 40-mg parecoxib sodium group (significant for 40-mg parecoxib sodium versus placebo). Four or more hours after surgery, the mean pain-intensity (categorical) score was significantly lower in both parecoxib sodium groups than in the placebo group. Preoperative administration of parecoxib sodium was well tolerated and significantly reduced postoperative pain in patients who had undergone bunionectomy. (J Am Podiatr Med Assoc 94(3): 305–314, 2004)

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2023-01-05

·BioSpace

Angle plc Announces Appointment of Non-Executive Director - Jan 05, 2023

Experienced life science executive, Juliet Thompson, joins ANGLE Board with immediate effect GUILDFORD, SURREY / ACCESSWIRE / January 5, 2023 / ANGLE plc ("the Company") (AIM:AGL)(OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce that Juliet Thompson has been appointed as a Non-Executive Director of the Company, with effect from 5 January 2023. Juliet has spent much of her career advising companies in the international life sciences sector, completing multiple financing and M&A transactions in Europe and the United States, helping companies raise in excess of US $4 billion to pursue their growth strategies. Juliet has held senior positions at WestLB Panmure and Stifel Europe and in 2003 was a co-founder of the specialist life science investment bank, Code Securities, later acquired by Nomura. Juliet currently has a number of roles, including Non-Executive Board positions at Indivior plc, Novacyt SA and the private company, OrganOx. She chairs the Audit Committees of all three companies and is a member of the remuneration and nomination committees. Juliet Thompson, commented: "As a founder of two businesses and with a long track record advising companies, I understand the challenges faced by executive management teams of growth companies. I have specialist knowledge in the areas of financing, strategy and corporate governance and I look forward to bringing this experience to ANGLE as the Company looks to further advance its world leading position in CTC liquid biopsy." ANGLE Chairman, Garth Selvey, added: "I am delighted that Juliet has agreed to join the Board of ANGLE at such an exciting time in our commercial development. Juliet has extensive experience in the life science sector and will strengthen the Board with her entrepreneurial expertise and deep knowledge of capital markets." Other than as disclosed below, there are no further disclosures to be made in connection with Juliet Thompson (age 56) in accordance with AIM Rule 17 and paragraph (g) of Schedule Two of the AIM Rules for Companies: Current Previous Indivior plc Vectura Group Limited Novacyt SA GI Dynamics, Inc. OrganOx Limited Nexstim Oyj Opus Trust Investments Limited Scapa Group Limited Opus 107 Limited Premier Vet Group plc Leadership Through Sport and Business ANGLE plc +44 (0) 1483 343434 Andrew Newland, Chief Executive Ian Griffiths, Finance Director Andrew Holder, Head of Investor Relations Berenberg (NOMAD and Joint Broker) Toby Flaux, Ciaran Walsh, Milo Bonser +44 (0) 20 3207 7800 Jefferies (Joint Broker) Max Jones, Thomas Bective +44 (0) 20 7029 8000 FTI Consulting Simon Conway, Ciara Martin Matthew Ventimiglia (US) +44 (0) 203 727 1000 +1 (212) 850 5624 The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the EU Market Abuse Regulation (596/2014). Upon the publication of this announcement via a regulatory information service, this information is considered to be in the public domain. For Frequently Used Terms, please see the Company's website on Notes for editors About ANGLE plc ANGLE is a world leading liquid biopsy company with sample-to-answer solutions. ANGLE's proven patent protected circulating tumor cell (CTC) harvesting technology is known as the Parsortix® system. ANGLE's Parsortix® system is FDA cleared for its intended use in metastatic breast cancer and is currently the first and only FDA cleared medical device to harvest intact circulating cancer cells from blood. Intended use The Parsortix® PC1 system is an in vitro diagnostic device intended to enrich circulating tumor cells (CTCs) from peripheral blood collected in K2EDTA tubes from patients diagnosed with metastatic breast cancer. The system employs a microfluidic chamber (a Parsortix cell separation cassette) to capture cells of a certain size and deformability from the population of cells present in blood. The cells retained in the cassette are harvested by the Parsortix PC1 system for use in subsequent downstream assays. The end user is responsible for the validation of any downstream assay. The standalone device, as indicated, does not identify, enumerate or characterize CTCs and cannot be used to make any diagnostic/prognostic claims for CTCs, including monitoring indications or as an aid in any disease management and/or treatment decisions. The Parsortix system enables a liquid biopsy (a simple blood test) to be used to provide the circulating metastatic breast cancer cells to the user in a format suitable for multiple types of downstream analyses. The system is based on a microfluidic device that captures cells based on a combination of their size and compressibility. The system is epitope independent and can capture all phenotypes of CTCs (epithelial, mesenchymal and EMTing CTCs) as well as CTC clusters in a viable form (alive). CTCs harvested from the system enable a complete picture of a cancer to be seen; as being an intact cell they allow DNA, RNA and protein analysis as well as cytological and morphological examination and may provide comparable analysis to a tissue biopsy in metastatic breast cancer. Because CTC analysis is a non-invasive process, unlike tissue biopsy, it can be repeated as often as needed. This is important because cancer develops and changes over time and there is a clear medical need for up-to-date information on the status of a patient's tumor. In addition, the live CTCs harvested by the Parsortix system can be cultured, which offers the potential for testing tumor response to drugs outside the patient. The Parsortix technology is the subject of 26 granted patents in Europe, the United States, China, Australia, Canada, India, Japan and Mexico with three extensive families of patents are being progressed worldwide. In the United States, the Parsortix® PC1 system has received a Class II Classification from FDA for use with metastatic breast cancer patients. FDA clearance is seen as the global gold standard. ANGLE's Parsortix system is the first ever FDA cleared system for harvesting CTCs for subsequent analysis. ANGLE has applied the IVD CE Mark to the same system for the same intended use in Europe. ANGLE has also completed three separate 200 subject clinical studies under a programme designed to develop an ovarian cancer pelvic mass triage test, with the results showing best in class accuracy (AUC-ROC) of 95.4% with sensitivity of 90% and specificity of 93%. This excellent clinical result demonstrates the utility of cells harvested by the Parsortix system, which the Company believes is the "best sample" for liquid biopsy analysis as it recovers intact, living cancer cells that are involved in the progression of the disease providing prospective information. ANGLE has established formal collaborations with world-class cancer centres and major corporates such as Abbott, Philips and QIAGEN, and works closely with leading CTC translational research customers. These Key Opinion Leaders (KOLs) are working to identify applications with medical utility (clear benefit to patients), and to secure clinical data that demonstrates that utility in patient studies. The body of evidence as to the benefits of the Parsortix system is growing rapidly from our own clinical studies in metastatic breast cancer and ovarian cancer and also from KOLs with 76 peer-reviewed publications and numerous publicly available posters from 33 independent cancer centres, available on our website. ANGLE has established clinical services laboratories in the UK and the United States to accelerate commercialisation of the Parsortix system and act as demonstrators to support product development. The laboratories offer services globally to pharmaceutical and biotech customers for use of Parsortix in cancer drug trials and, once the laboratories are accredited and tests validated, will provide Laboratory Developed Tests (LDTs) for patient management. This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit . SOURCE: ANGLE plc View source version on accesswire.com:

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