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BioWorld - Monday, May 11, 2026
Home » Topics » Clinical

Clinical
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T cells

Soligenix sees the light, posts supportive phase III data as FDA talks continue

May 4, 2023
By Lee Landenberger
While sorting out a second phase III study design for its cancer therapy and light device with the U.S. FDA, Soligenix Inc. produced positive results from a compatibility study evaluating Hybryte (synthetic hypericin sodium) for treating early stage cutaneous T-cell lymphoma (CTCL). That data, according to Soligenix, bolster findings from the phase III FLASH study, which used the same combination in treating CTCL. According to Christopher Schaber, Soligenix CEO, the important corporate objectives for the compatibility study were to replicate results seen in the FLASH study.
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Red blood cells coagulating
Hematologic

Blood thinner class dissolves blood clots without increasing bleeding risk

May 3, 2023
By Subhasree Nag
Blood clots can lead to life-threatening conditions such as deep vein thrombosis, heart attack, pulmonary embolism and stroke. Blood thinners are essential in the treatment and prevention of blood clots but carry a significant risk of bleeding as they target enzymes essential for blood clotting. Researchers at the University of British Columbia (UBC) and the University of Michigan have developed a new class of blood thinners that can specifically target clots without increasing the risk of bleeding.
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Speech being decoded from brain patterns using fMRI

May 3, 2023
By Nuala Moran
A non-invasive method has been developed for decoding speech from brain patterns captured by functional magnetic resonance imaging (fMRI) data.
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Amyloid plaques forming between neurons

What CRL? After accelerated diss, Lilly to seek full approval on solid phase III Alzheimer’s readout

May 3, 2023
By Jennifer Boggs
In January, a Wall Street analyst predicted the U.S. FDA’s rejection of Eli Lilly and Co.’s application seeking accelerated approval of amyloid beta-targeting Alzheimer’s candidate, donanemab, would be a “mere footnote” in the drug’s development, a forecast confirmed in the wake of positive top-line phase III data showing donanemab significantly slowed cognitive and functional decline in people with early symptomatic disease.
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Mirv’n on up: Elahere boosts Immunogen’s economics with phase III win in PROC

May 3, 2023
By Randy Osborne
Immunogen Inc. scored a major win in top-line data from the confirmatory phase III trial called Mirasol evaluating the approved antibody-drug conjugate Elahere (mirvetuximab soravtansine-gynx, “mirv”) vs. chemotherapy in patients with folate receptor alpha-positive platinum-resistant ovarian cancer (PROC). The victory led shares of the Waltham, Mass.-based firm to close May 3 at $12.26, a rise of $7.06, or 135%.
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Lab chip skin wound healing with electricity

Electric stimulation heals chronic wounds three times faster, study

May 2, 2023
By Shani Alexander
Using direct current to stimulate a chronic wound can help it to heal up to three times faster, researchers from Chalmers Institute of Technology, Sweden, and the University of Freiburg, Germany, found. Working from a well-known hypothesis that the skin is electrostatic, the researchers engineered a microfluidic biochip on which skin cells were cultured. They then made tiny wounds in two cells. One was allowed to heal naturally while the other was stimulated with electricity.
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Kidney disease illustration

Travere to deal with FDA after Filspari door number two opens weak in FSGS Duplex trial

May 2, 2023
By Randy Osborne
Saddled with disappointing results from a phase III trial with Filspari (sparsentan) in focal segmental glomerulosclerosis (FSGS), officials of Travere Therapeutics Inc. stressed the differences between that disorder and IgA nephropathy (IgAN) – for which the drug was cleared by the U.S. FDA in February. Two-year IgAN efficacy data are due in the fourth quarter of this year.
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Illustration of human papillomavirus (HPV) infection

Antiva targets CIN with topical tablet, raises $53M

May 2, 2023
By Karen Carey
A precancerous condition caused by the human papillomavirus (HPV) affects up to 300,000 American women who are diagnosed each year, and yet there are no treatments, just preventive vaccines introduced in 2006 – targeted to younger generations prior to the first sexual encounter. That leaves a large proportion of the female population stuck with a “wait-and-see” approach that involves continuous monitoring of their HPV infection through pap smears to detect cellular changes that could lead to cervical cancer. South San Francisco-based Antiva Biosciences Inc. is seeking to find a better response to this condition known as high-grade cervical intraepithelial neoplasia (CIN2,3) with its lead topical therapeutic, ABI-2280, a prodrug of an acyclic nucleoside phosphonate that is currently in phase I trials.
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Digital lungs illustration

Pliant data yield good results but a droopy stock

May 1, 2023
By Lee Landenberger

Despite posting positive phase IIa data, Pliant Therapeutics Inc. stock (NASDAQ:PLRX) took a punch May 1 as shares closed 21% downward at $22.31 each. Still, the stock is in far better shape than it was a year ago when shares were going for about $5 each.


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Clinical research concept with medical icons on light bulb
Vascular Access Society Congress

Xeltis synthetic vascular access graft shown to be patent in humans

April 28, 2023
By Nuala Moran
Xeltis AG reported the first-in-human results for its fully synthetic electrospun vascular access graft, showing 100% patency at six months in 20 patients with end stage renal disease who were not suitable for arteriovenous (AV) fistula creation.
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