• Telix Pharma releases positive study results for TLX101
  • Imugene doses first patient in Phase 1 clinical trial

Final IPAX-1 study data has confirmed the safety and tolerability profile for TLX101, according to Telix Pharma (ASX:TLX).

The study of TLX101 was done in combination with external beam radiation therapy (EBRT) in recurrent glioblastoma multiforme (GBM).

The primary objective of the IPAX-1 study was to evaluate the safety and tolerability profile of intravenous TLX101 administered concurrently with second line EBRT in patients with recurrent GBM.

Final data up to the completion of the post-study follow-up periodconfirmed that the study has met this primary objective.

The study also delivered encouraging preliminary efficacy data for further evaluation, demonstrating a median overall survival (OS) of 13 months from the initiation of treatment, or 23 months from initial diagnosis.

Given that GBM has a median survival from initial diagnosis of 12-15 months, the overall survival improvement trend seen clearly warrants further evaluation in a larger patient population.

Recurrent GBM is a highly aggressive cancer that progresses rapidly, for which there are currently few effective treatment options.

TLX101 is a targeted radiation therapy that targets L-type amino acid transporter 1 (LAT-1), which is typically over- expressed in GBM.

TLX101 has been granted orphan drug designation in the United States and Europe.


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Imugene progresses Phase 1 trial

Meanwhile, Imugene (ASX:IMU) reported the first patient has been dosed in intravenous cohort 1 as part of its VAXINIA Phase 1 clinical trial.

The Phase 1 MAST (metastatic advanced solid tumours) study is evaluating the safety of novel cancer-killing virus CF33-hNIS (VAXINIA).

The dosing of this patient follows the recent announcement that intratumoral (IT) cohort 1 had cleared, paving the way for both cohort 2 of IT administration and cohort 1 of IV administration.

The study has to date delivered a low dose to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment.

The oncolytic virus, which was developed by LA-based City of Hope, has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models.

Earlier this week, Imugene also announced it had received a licence from the Australian Government’s Office of Gene Technology Regulator, allowing for expansion of the trial within Australia.



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