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Health & Biotech
Imricor Medical Systems (ASX:IMR) has announced the installation of iCMR capital equipment at the world-renowned Lausanne University Hospital (CHUV) in Lausanne, Switzerland, is complete.
IMR says installation had been waiting for Swiss registration of the third party HAT 500 ablation generator manufactured by Osypka, a process that completed last week.
CHUV recently completed the construction of a cardiology-owned dedicated iCMR lab, specifically built for IMR’s procedures.
IMR says with installation complete, and having previously received all required approvals, CHUV is ready to start participation in the VISABL-AFL trial, supporting US FDA approval of its products.
CHUV will be the third site to commence enrolment processes, joining Johns Hopkins and the Cardiovascular Institute of South Paris (ICPS), who treated their first patients in the trial last week.
First patient enrolment at CHUV for VISABL-AFL is expected in August, following clinical trial start-up activities, which include the installation of IMR’s NorthStar 3D Mapping System and on-site training performed by Imricor clinical personnel.
CHUV will also be one of the company’s European Centres of Excellence, an important partnership where physicians from other hospitals can visit and be trained on real-time iCMR cardiac ablations and other future interventions, as the number of active sites across Europe continues to grow.
PYC Therapeutics (ASX:PYC) has announced that the safety review committee (SRC) governing the company’s single ascending dose (SAD) study in patients with Retinitis Pigmentosa type 11 (RP11) has reviewed the four-week safety data from patient cohort four and recommended continuing with the clinical trial as planned.
Each patient in cohort four received a single 75 µg intravitreal dose of PYC’s investigational drug candidate for RP11, known as VP-001) in one eye.
VP-001 was considered safe and well-tolerated at four-weeks of follow up in all four patient cohorts who have received the
drug to date with no evidence of treatment emergent serious adverse events (TE-SAEs).
PYC says there were importantly no treatment emergent adverse events (TE-AEs) in any patient in cohort four of the SAD.
The company will now progress to a multiple ascending dose (MAD) study with the two highest doses established as being safe and well-tolerated in the SAD (30 and 75 µg respectively) to be administered in a repeat dose format in the MAD.
PYC is also currently evaluating a further dose escalation of VP-001 in the context of the safety/tolerability profile of the drug candidate observed to date.
The biotech says it will make a final decision as to whether to include higher doses (above 75 micrograms) of VP-001
in the MAD after reviewing both the safety and efficacy data that will be generated in the SAD and MAD studies through H2 2024.
Both studies are expected to have concluded in 2025, at which time PYC will evaluate the safety/tolerability and efficacy profile of VP-001 before progressing into a registrational trial in the event of successful outcomes.
Clinical-stage biotech specialising in cell therapeutics Cynata Therapeutics (ASX:CYP) has inked a deal with TekCyte Limited (TekCyte) to acquire its wound dressing technology.
TekCyte’s technology is a core component of CYP’s Cymerus iPSC1-derived MSC2 topical wound dressing product candidate, CYP-006TK, currently being investigated in an ongoing clinical trial in patients with diabetic foot ulcers (DFU).
In 2021 CYP entered into a worldwide exclusive licence agreement with TekCyte to use the technology, which is based on proprietary surface modification techniques, to produce polymer-coated dressings for the delivery of MSCs to wounds.
CYP has now agreed to secure outright ownership of the underlying TekCyte tech and will issue shares to the value of $230k to TekCyte.
The shares to be issued will be priced at the volume weighted average price at which Cynata’s shares trade on the ASX during the five trading days preceding the completion of an intellectual property assignment.
CYP says patient enrolment in the DFU trial has been completed with initial results promising. An analysis of the first 16 patients enrolled after 10 weeks’ follow-up showed a median percentage reduction in wound surface area of 87.6% in the active CYP-006TK group, compared to 51.1% in the control group.
“Ownership of this technology strengthens our intellectual property position and simplifies our commercial proposition for potential partners,” CYN CEO and managing director Dr Kilian Kelly says in an announcement.
We are very excited by the initial results in our trial of CYP-006TK in DFU, and optimistic about the potential for this product to meaningfully change outcomes for patients.”
Cannabis medicines play Zelira Therapeutics (ASX:ZLD) has announced that it has secured a US$1.4 million unsecured loan not from chairman Osagie Imasogie on attractive terms to support advancement of the HOPE SPV clinical trial and for general working capital purposes.
ZLD says the loan note is considered by the board to be on terms favourable to the company particularly considering current market and economic conditions.
The loan note is subject to shareholder approval to be sought at the upcoming 2024 AGM and will become a convertible loan note with a US 40 cents conversion price, represents a more than 100% premium to the closing price on June 28, 2024.
ZLD says in the event that shareholders do not approve the conversion, the company will pay a loan termination fee of 10%, at the same time that the loan note is repaid.
Health & Biotech
Health & Biotech
Health & Biotech
