- Firebrick Pharma reopens recruitment for Phase 3 trial
- MGC Pharma given OTC status in FDA’s NDC database
- Chimeric received positive feedback from the FDA
Firebrick Pharma (ASX: FRE) surged 7% this morning after announcing that its Phase 3 clinical trial of Nasodine Nasal Spray has received the necessary ethics approvals to reopen for the 2023 common cold season.
Nasodine is a spray treatment used to treat the common cold.
Two clinical sites in Australia are now open for recruitment, and three sites in South Africa will be open in the next week. This trial was 50% recruited in 2022, and then paused over the summer months with the stated goal of reopening this month.
The trial will enrol 196 adult subjects with confirmed viral colds. In 2022, 100 subjects were already confirmed so the goal in 2023 is to enrol the remaining 96 subjects.
Meanwhile, MGC Pharma (ASX:MXC) surged almost 30% today after announcing that ArtemiC has been listed as an over-the-counter (OTC) status on the FDA’s National Drug Code Database (NDC).
The OTC status means that ArtecmiC, MGC’s proprietary clinically tested COVID 19 treatment, could now be sold through the US Pharmacy Benefit Management (PBM) networks starting in April.
The successful listing was facilitated by MGC’s supply and distribution partner, AMC Pharma.
Now that the NDC has been listed, AMC wasted no time in negotiating shelf space with some of the largest US pharmacy networks and independent pharmacies.
In addition, AMC has submitted a purchase order for US$2m of ArtemiC with MGC for immediate production and delivery in two instalments over Q3 and Q4 of this year.
FDA gives feedback to Chimeric
Meanwhile, Chimeric Therapeutics (ASX:CHM) has received positive feedback from the US FDA regarding its proposed Phase 1 clinical trial in gastrointestinal and neuroendocrine tumors using lead drug, CHM 2101.
The company says this is a significant milestone towards an FDA Investigational New Drug (IND) Application and Phase 1 clinical trial.
The objective of the meeting was to facilitate FDA regulatory communication and guidance through the IND submission process.
The meeting included details and specific questions regarding the clinical development plan and technical operations, as well as drug product manufacturing and quality release plan for CHM 2101.
“We are highly appreciative of the FDA’s support and guidance as this brings us closer to potentially transforming the lives of patients with gastrointestinal and neuroendocrine tumours,” said Jennifer Chow, Chimeric’s CEO.
CHM 2101 is a first in class, third generation autologous CAR T cell therapy invented at the world-renowned cell therapy centre, the University of Pennsylvania.
Preclinical evidence for CHM 2101 was published in March 2022 in Nature Cancer, with the data demonstrating strong evidence of efficacy with complete eradication of eight different types of gastrointestinal cancers with no relapse or toxicity.
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