• Biotron commences human trial of COVID-19
  • Pancreatic trial news from Noxopharm and Clarity Pharma
  • Vectus completes dosing of last cohort


Biotron (ASX:BIT) jumped 6% this morning after announcing the start of a human trial of its lead antiviral drug BIT225 against COVID-19.

The latest COVID-19 trial of BIT225 has been approved as a sub-study to the ongoing Phase 2 BIT225-010 HIV-1 clinical trial currently in progress at sites in Thailand.

That trial has already enrolled 27 people, and those who are diagnosed with symptomatic COVID-19 infection during the six-month treatment period will now be enrolled in the sub-study.

The sub-study will look into the SARS-CoV-2 viral load and clinical symptoms over a 28-day period.

Bitron’s BIT225 has demonstrated both antiviral and favourable immunomodulatory effect in its current development for HIV-1.

It has also demonstrated both antiviral, immune modulatory and clinical benefit against SARS-CoV-2 in a murine model of disease.

The sub-study will follow the same timetable as the parent HIV-1 trial, and will be expected to conclude in February 2023 with preliminary results anticipated in mid-2023.

“There are minimal additional costs associated with the sub-study, and no expected impact on timing of the results of the BIT225-010 trial as it is fully recruited,” said Biotron’s CEO, Dr Michelle Miller.


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Noxopharm publishes good results

Noxopharm (ASX:NOX) has published its first anti-cancer results from its preclinical ‘dual-cell’ therapy drug.

The results show that tumour cells decreased by up to 85% and barrier cells reduced by up to 87%.

The study involves Noxopharm’s novel preclinical drug that attacks pancreatic cancer in a different and innovative way.

Pancreatic cancer is especially difficult to treat because the tumours are surrounded by a dense barrier of cells that protects them from anti-cancer drugs, as well as from the body’s immune system.

These barrier cells also help the cancer spread to the rest of the body, adding to the challenge of developing treatments.

Noxopharm conducted an 18-month study as part of an ongoing collaboration with UNSW to test the new drug which was developed by the company, known as CRO-67.

The study was conducted using a cutting-edge model developed by the university.

The “dual cell’ effect of CRO-67 refers to the killing both cancer cells and their barrier cells to achieve a more profound anti-cancer treatment outcome.

The study will now be followed by more tests on the therapeutic efficacy of CRO-67, as well as deeper analysis into the mechanisms by which CRO-67 exerts its ‘dual-cell’ targeting effects.

Several additional studies will need to be performed to support the research required to move CRO-67 towards clinical trials.

Clarity Pharma completes patient recruitment for Phase 2

In another prostate cancer study, first participants have been recruited and imaged in Clarity Pharma’s (ASX:CU6) diagnostic investigator-initiated trial (IIT).

The trial is led by Prof Louise Emmett at St Vincent’s Hospital Sydney studying one of Clarity’s core products, SAR-Bombesin.

“SAR-Bombesin has already shown very promising data to date through a SAS case study, demonstrating diagnostic imaging potential in PSMA-negative prostate cancer and highlighting potential utility of the product as a theranostic agent,” said Prof Louise Emmett, principal investigator in the trial.

Vectus completes dosing of last patient cohort

Vectus Biosystems (ASX:VBS) has completed the third and last of the three planned cohorts in the Multiple Ascending Dose (M.A.D.) segment of its first-in-human trial.

The study is investigating the effect of Vectus’ asset VB0004 when administered orally to healthy volunteers; and to patients with mild to moderate hypertension with low cardiovascular risk.

In this cohort of normal healthy subjects who received a 100mg dose of VB0004 for 14 consecutive days, no significant adverse events were reported.

Overall, the results reinforce previous evidence that VB0004 will be amenable to once daily dosing, a desirable feature in medications for chronic conditions such as hypertension, heart failure, kidney failure and pulmonary fibrosis.

“This is particularly pleasing as we move towards the next phase of testing of a compound that can have a significant and widespread global positive impact on disease, the pathology of which has many aetiologies,” said Vectus chairman, Dr Ronald Shnie.


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