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April 27, 2021updated 12 Jul 2022 11:18am

SciClone starts trial of Covid-19 vaccine and Zadaxin combination

Chinese company SciClone Pharmaceuticals has begun a clinical study of the Covid-19 inactivated vaccine combined with Zadaxin (thymalfasin) in the country.

Chinese company SciClone Pharmaceuticals has begun a clinical study of the Covid-19 inactivated vaccine combined with Zadaxin (thymalfasin) in the country.

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
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A thymic hormone drug, Zadaxin naturally circulates in the blood. It is approved as a vaccine enhancer for treating individuals with chronic hepatitis B and immune impairment.

The prospective, open and randomised controlled study will analyse the vaccine’s safety, tolerance, and immunogenicity in healthy adult subjects.

With 15 hospitals in the People’s Republic of China participating, the study intends to enrol a total of 200 subjects.

Considering Zadaxin’s mechanism of action and prior clinical studies, the company noted that the combination could aid in boosting the SAR-Cov-2 neutralising antibody level and extend the antibody protection time.

In a separate development, Algernon Pharmaceuticals has filed an end of Phase 2 meeting request (EOP2) with the US Food and Drug Administration (FDA).

This development comes after the company concluded the Phase IIb part of its Phase IIb/III Covid-19 trial of NP-120 (Ifenprodil).

According to data from the Phase IIb part, 0% mortality was observed in the 20mg dose Ifenprodil treatment arm versus a 3.3% mortality rate in the untreated control arm, at day 15.

The goal of the EOP2 meeting is to enable discussions between the FDA and sponsors who seek guidance on the clinical trial design, to decide the safety of proceeding to Phase III, to assess the Phase III plan.

It will include interactions on protocols and endpoints for adequacy and to obtain data required to support a marketing application.

The company earlier said that it will submit a briefing package that has a summary of study data and a protocol synopsis for a potential Phase III trial as part of the filing.

According to the FDA guidelines, Algernon Pharmaceuticals should get a response within 70 days. Since the meeting is based on a Covid-19 clinical trial, the response could be expedited.

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
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