KZA Announces Superior Safety and Tolerability Data From GDC-0084’s Phase IIa Study

  • May 06, 2019 AEST
  • Team Kalkine
KZA Announces Superior Safety and Tolerability Data From GDC-0084’s Phase IIa Study

Kazia Therapeutics Limited (ASX: KZA) is an oncology-focused biotechnology company, developing innovative anti-cancer drugs. On 6th May 2019, Kazia Therapeutics Limited announced new safety data from its ongoing Phase IIa study of GDC-0084 in the newly-diagnosed patients with glioblastoma (GBM).

GDC-0084, which is a novel targeted therapy that inhibits the PI3K pathway, received licensed from Genentech in October 2016. GDC-0084 is important in many forms of cancer and has activated in 85% to 90% of GBM cases. The drug is used in a once daily dose and is administered orally.

In patients with recurrent disease, the Phase IIa study has determined the 60mg maximum tolerated dose in these patients, which is substantially higher than 45mg dose found during Genentech’s Phase I study.

In this Phase IIa study, the dose-limiting toxicities comprised of oral mucositis (mouth ulcers) and hyperglycemia (elevated blood sugar), which are the expected effects of the PI3K inhibitor class of drugs.

The Phase IIa study of GDC-0084 is divided into two parts. The first one is a dose optimisation component, which is designed in such a manner that it will find out if the newly-diagnosed patients can tolerate a higher dose of GDC-0084 than advanced recurrent patients. Depending on the safety signal, this part of the trial was expected to enroll between six to 18 patients. For this phase, a total of eight patients were required. This study will now be transitioned into the dose expansion, where an additional 20 patients will be recruited who will receive a dose of 60mg. The second part of the study will be designed to provide confirmatory efficacy signals. The company expects that the initial data will be reported in the Q4 of CY2019.

To understand the milestone of Kazia Therapeutics Limited in 2018, click here.

On 19th March 2019, Kazia Therapeutics Limited entered into an agreement to sell its remaining holding in the ordinary shares of Noxopharm through a single block trade and expected to generate proceeds of around $2.1 million which will be applied to the R&D program of Kazia.

In the H1 FY2019, revenue experienced a significant nosedive of 56.5%. The company incurred a significant loss of 1519.1% to $6.028,195. The balance sheet of the company reported a decrease in the net asset base as a result of a fall in the total assets. The total shareholders’ equity during the period was $18,365,320.

The company used $4,360,738 in the H1 FY2019, which was significantly less than its previous corresponding period. The company generated net cash of $3,815,695 from the issue of shares. At the end of the first half of FY2019, Kazia Therapeutics Limited had net cash and cash equivalent of $5,411,139.

The stock has generated a decent YTD return of 39.71%. At market close on 6th May 2019, the stock of KZA was trading at A$0.485, up 2.105% as compared to its previous closing price. Kazia Therapeutics Limited holds a market capitalisation of $29.53 million with approximately 62.17 million outstanding shares.


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