• Universal Bio completes patient recruiting for Xprecia Prime study
  • Neuren Pharma given approval by FDA to start Phase 2 trial
  • Chimeric completes Phase 1A trial with flying colours

 

Universal Bio to lodge FDA submission this quarter

Universal Biosensors (ASX:UBI) surged 10% this morning as it announced the completion of patient recruiting for its 360-patient “Xprecia Prime” PT/INR blood coagulation clinical study.

The study was designed to provide clinical evidence as to the performance and safety of Xprecia Prime, and will be used in UBI’s 510K submission to the FDA, which is expected to be lodged during Q1 this year.

Earlier, the study protocol was discussed at a FDA Pre Submission meeting as the company prepares to conduct the trials at five clinical sites in the US.

“The completion of the clinical study in the USA is a key milestone for the future of UBI’s coagulation business,” said UBI CEO, John Sharman.

Sharman said UBI has spent more than 10 years developing its Point of Care coagulation platform, and the data generated by the clinical study so far is strong.

He acknowledged that UBI’s existing coagulation product (Xprecia Stride) has insignificant sales in the US, which represents about 50% of the estimated global US$1 billon PT/INR market.

“We expect an approval to sell Xprecia Prime in the USA will add significant value to our coagulation business into the future,” Sharman added.

 

Neuren Pharma gets IND approval from the FDA

Neuren Pharma (ASX: NEU) today announced that the US FDA has given an IND approval for Neuren to proceed with the planned Phase 2 clinical trial in children with PWS (Prader-Willi Syndrome).

PWS is a highly debilitating neuro-developmental disorder, caused by defects in the 15q11-q13 region of chromosome 15.

The estimated incidence is 1 in 10,000 to 30,000 males and females across all races and ethnicities.

Infants with PWS have very low muscle tone and suffer from feeding difficulties, which can lead to morbid obesity.

Apart from PWS, Neuren’s Phase 2 trials on lead asset NNZ-2591 are focusing on three other serious neurological disorders that emerge in early childhood, including Angelman, Phelan-McDermid and Pitt Hopkins syndromes.

All four programs have been granted Orphan Drug designation by the FDA.

Neuren has previously reported positive results in the Magel2-null mouse model of Prader-Willi syndrome.

The study found that treatment with NNZ-2591 for six weeks normalised fat mass, insulin levels, IGF-1 levels and all behavioural deficits.

 

Chimeric’s Phase 1 trial shows promise

Cell therapy biotech Chimeric Therapeutics (ASX:CHM) reported that all patients dosed in the 3rd patient cohort in the Phase 1A clinical trial have now advanced beyond the 28-day follow up period without experiencing dose-limiting toxicities.

The trial is being held at the City of Hope National Medical Center in LA, and is studying Chimeric’s CHM 1101 (CLTX CAR-T) drug.

The patients were administered a total dose of 240 X 106 CHM 1101 (CLTX CAR-T) cells through dual routes of intratumoral (ICT) and intraventricular (ICV) administration.

Following the encouraging results today, the Phase 1 clinical trial will now advance to the fourth and final dose cohort, with a total dose of 440 X 106 CHM 1101 (CLTX CAR-T) cells.

Chimeric has licensed the exclusive global rights to intellectual property covering the chlorotoxin CAR-T cells from City of Hope.

Study objectives are to evaluate the safety and efficacy of CLTX CAR-T, and to establish recommended dosing for a future Phase 2 trial.

 

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