P-I/II

PharmaShots Interview: Recce Pharmaceuticals’ James Graham Shares Insight on the P-I/II Clinical Trial of RECCE 327 (R327) for Infected Burn Wounds

In an interview with PharmaShots, James Graham, CEO of Recce Pharmaceuticals shared his views on the multiple patient dosing in P-I/II clinical trial of RECCE 327 (R327) for the treatment of infected burn wounds. Shots: The multiple patients have been dosed in P-I/II trial evaluates the effectiveness & safety of RECCE 327 in 30 patients …

PharmaShots Interview: Recce Pharmaceuticals’ James Graham Shares Insight on the P-I/II Clinical Trial of RECCE 327 (R327) for Infected Burn Wounds Read More »

BioMarin Reports FDA’s Hold on P-I/II Phearless Trial of BMN 307 in Adults with PKU

Shots: The FDA’s clinical hold is based on interim safety findings from a pre-clinical study which showed that 6/7 animals treated with BMN 307 (2e14 Vg/kg) had tumors on liver necropsy @52wks. after dosing with evidence for integration of portions of AAV vector into the genome No lesions were observed in any mice @24wks. 5 …

BioMarin Reports FDA’s Hold on P-I/II Phearless Trial of BMN 307 in Adults with PKU Read More »

Roche Enters into a Clinical Collaboration with Treos Bio for PolyPEPI1018 + atezolizumab in P-I/II Trial to Treat Late Stage Microsatellite Stable Metastatic Colorectal Cancer

Shots: The companies collaborated to evaluate Treos’ PolyPEPI1018 (Polypeptide cancer immunotherapy) + Roche’s atezolizumab (PD-L1-inhibitor) in P-I/II trial in patients with late-stage MSS mCRC which is expected to initiate in Q4’21 Treos has completed a P- I/II OBERTO 101 study for PolyPEPI1018 as 1L maintenance setting in patients with MSS mCRC that demonstrates the therapy …

Roche Enters into a Clinical Collaboration with Treos Bio for PolyPEPI1018 + atezolizumab in P-I/II Trial to Treat Late Stage Microsatellite Stable Metastatic Colorectal Cancer Read More »

uniQure Provides Positive Recommendation to Advance P- I/II Study of AMT-130 for Huntington Disease

Shots: The DSMB recommended continued the dosing in the P- I/II clinical trial assessing AMT-130 in patients with a second higher-dose cohort, after review safety data from the first cohort of ten patients The first cohort of P- I/II trial for AMT-130 in 10 patients out of which six patients received treatment with AMT-130 and …

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Sanofi and Translate Bio Initiate P-I/II Study of MRT5500 Against COVID-19

Shots: The companies reported the initiation of P-I/II trial to evaluate the safety, tolerability, and immunogenicity of MRT5500 (1 or 2doses given 21 days apart) vs PBO in ~415 healthy adults aged ≥18yrs. with its expected interim results in Q3’21 The study will evaluate three different dose levels of MRT5500 (15/45/135µg). The preclinical data of …

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Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273 in Japan

Shots: Takeda has submitted an NDA to MHLW to import and distribute Moderna’s (mRNA-1273/ TAK-919) in Japan Takeda is conducting a P- I/II study assessing the safety and immunogenicity of two vaccinations of TAK-919 (100μg, given 28 days apart) in 200 participants aged ≥20yrs. followed through 12mos. after the second vaccination. Takeda has completed enrollment …

Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273 in Japan Read More »

Takeda Reports First Patients Dosing in P-I/II Study of Novavax’s COVID-19 Vaccine Candidate in Japan

Shots: Takeda is providing rapid & sustained access to COVID-19 vaccines in Japan through partnerships with Novavax and Moderna. Earlier, Takeda has completed enrollment in the P-I/II study of TAK-919 in Japan The studies are designed to include 200 healthy Japanese adults followed by 12mos. after the second vaccination with primary results expected in CY2021. …

Takeda Reports First Patients Dosing in P-I/II Study of Novavax’s COVID-19 Vaccine Candidate in Japan Read More »

Zydus Cadila Seeks Approval to Commence P-III Clinical Study of ZyCoV-D

Shots: The company reported that the COVID-19 vaccine is safe, well-tolerated & immunogenic in the P-I/II study & plans to initiate P-III clinical trial in ~30000 volunteers upon receiving necessary approvals The P-II study of ZyCoV-D had been conducted in ~1000 healthy adult volunteers as part of the adaptive P-I/II dose-escalation study The trial has …

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Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19

Shots: The companies reported that most advanced of four COVID-19 vaccine candidates from their BNT162 mRNA-based vaccine program demonstrated the ability to elicit high SARS-CoV-2 neutralizing titers following the second dose in an ongoing P-I/II study in Germany The results divulge that BNT162b1 candidate induced strong CD4+ and CD8+ T-cell responses. BNT162b1 elicits RBD-specific, interferon-g+, …

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Zydus Initiates Adaptive P-I/II Clinical Study Evaluating its ZyCoV-D Against COVID-19 in India

Shots: Zydus has commenced the adaptive P-I/II human clinical trials of its plasmid DNA vaccine, ZyCoV-D and reported its first human dosing The Adaptive P-I/II dose escalation study will assess the safety, tolerability, and immunogenicity of the vaccine in ~1000 candidates across multiple clinical sites in India. The company has already manufacture clinical GMP batches …

Zydus Initiates Adaptive P-I/II Clinical Study Evaluating its ZyCoV-D Against COVID-19 in India Read More »