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BioWorld - Sunday, May 28, 2023
Home » Topics » Clinical

Clinical
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Study shows Exact benefit of early cancer diagnosis

May 26, 2023
By Annette Boyle
No Comments
Exact Sciences Corp.’s long-term analysis of results from the Detecting cancers Earlier Through Elective mutation-based blood Collection and Testing (DETECT-A) study found that all patients diagnosed and treated for stage I or II cancers identified through its blood-based multi-cancer early detection (MCED) test remained cancer-free more than four years after diagnosis. Half of all the participants with cancer detected remained alive at four years, notable because most of the detected cancers had no recommended screening tests or standards. The results will be presented at the American Society of Clinical Oncology meeting June 2-6.
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EuroPCR 2023

Renal denervation, the comeback kid

May 26, 2023
By Shani Alexander
No Comments
Renal denervation (RDN) was described as the “comeback kid” at the recent EuroPCR conference in Paris where participants argued that following the success seen in several sham-controlled trials, there is now no doubt about the safety and the efficacy of the technology as a treatment for hypertension. The device-based procedure should now be used as a therapy option to reduce high blood pressure in patients, delegates heard.
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Despite setbacks momentum in ALS builds

May 26, 2023
By Cormac Sheridan
No Comments
Lack of efficacy brought the development of two investigational agents for amyotrophic lateral sclerosis (ASL) to a halt over the past week. On May 23, Wave Life Sciences Inc. disclosed that its stereopure antisense oligonucleotide WVE-004 failed to demonstrate clinical benefit after 24 weeks of treatment on a phase Ib/IIa trial in familial ALS patients or frontotemporal dementia patients. And on May 25, Apellis Pharmaceuticals Inc. and its partner, Swedish Orphan Biovitrum International AB, said that pegcetacoplan failed to meet its primary endpoint of a one-year phase II trial in patients with sporadic disease.
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Clinical trial virtual display

UK investing £121M to revive clinical trial activity as part of overall life sciences boost

May 26, 2023
By Nuala Moran
No Comments
The U.K. government has announced £121 million (US$148 million) in funding to reboot the commercial clinical trials system after a sharp decline saw the number of industry-sponsored studies falling by 44% from 2017 to 2021.
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antigraft.jpg

Reddress lands $26M for autologous wound management system

May 25, 2023
By Meg Bryant
No Comments
Reddress Ltd. secured $26 million in a series D financing aimed at further advancing its autologous, point-of-care wound management solution. The funds will be used to grow uptake of its Actigraft product suite, pursue global partnerships and expand its blood-based technology to treat more conditions.
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Mirati’s sitravatinib combo fails in phase III lung cancer trial

May 25, 2023
By Karen Carey
No Comments
Providing no details, Mirati Therapeutics Inc. failed to meet its overall survival primary endpoint in the phase III Sapphire trial with sitravatinib. The receptor tyrosine kinase inhibitor was tested in combination with anti-PD-1 checkpoint inhibitor Opdivo (nivolumab, Bristol Myers Squibb Co.) vs. docetaxel in patients with second- or third-line advanced nonsquamous non-small-cell lung cancer. According to Mirati, this patient population consists of about 70,000 people in the U.S. and Europe who have derived prior benefit from a PD-(L)1 inhibitor.
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Bioxcel has mixed phase III data and tough stock day

May 25, 2023
By Lee Landenberger
No Comments
Mixed phase III study results have Bioxcel Therapeutics Inc. moving ahead to complete the clinical trial while withstanding a hammering from investors. BXCL-501 (dexmedetomidine), a sublingual film being developed to treat bipolar disorders- or schizophrenia-associated agitation, produced clinically meaningful efficacy results in part 1 of the pivotal study with half of the approved dose, but the primary efficacy endpoint was not statistically significant at two hours (p=0.077). BXCL-501 separated from placebo at four hours (p=0.049).
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Eye and financial charts

Annexon sights BCVA benefit in missed-endpoint GA phase II

May 25, 2023
By Randy Osborne
No Comments
On the strength of upside in best corrected visual acuity (BCVA) in patients with geographic atrophy (GA), Annexon Inc. officials will meet with the U.S. FDA to talk about what’s next for ANX-007, after the C1q inhibitor missed the phase II trial’s primary endpoint: mean rate of change, or slope, in the GA lesion area compared to sham.
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COVID-19 vaccine and syringe with flag of China

Cansino steps closer to COVID-19 mRNA vaccine approval in China

May 24, 2023
By Doris Yu
No Comments
Cansino Biologics Inc. reported positive data in a phase IIb trial evaluating the heterologous mRNA vaccine CS-2034 booster compared to an inactivated vaccine to prevent SARS-CoV-2 infections.
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Central nervous system

PTC stays the course after phase III Friedreich’s miss; sky clearer for Skyclarys?

May 24, 2023
By Randy Osborne
No Comments
“We clearly see an active drug here,” PTC Therapeutics Inc. CEO Matthew Klein said of the 15-lipoxygenase inhibitor vatiquinone for Friedreich’s ataxia (FA), tested in a phase III study called Move-FA that missed the primary endpoint of statistically significant change in modified FA Rating Scale score at 72 weeks. The company will “take one step at a time” decisions about the drug, analyzing the results and then consulting with the U.S. FDA regarding how to proceed, he said. Meanwhile, Wall Street wasn’t happy, and South Plainfield, N.J.-based PTC’s shares (NASDAQ:PTCT) closed May 24 at $46.95, down $11.46, or 19.6%.
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