PR93296

Australian biotech company Starpharma announces positive interim results from the prostate cancer cohort in its ongoing phase 2 trial of DEP(R) cabazitaxel

MELBOURNE, Australia, Nov. 26, 2021 /PRNewswire=KYODO JBN/ --

Starpharma showed that 100% of evaluable patients with Stage IV prostate cancer

have had efficacy responses, utilising one or more standard measures of disease.

DEP(R) cabazitaxel(https://starpharma.com/drug_delivery/dep_cabazitaxel)is a

patented, detergent(polysorbate-80[1])-free, nanoparticle version of the

conventional cancer drug, Jevtana(R) - a leading oncology agent used to treat

advanced prostate cancer. Sales of Jevtana(R) exceeded US$600 million in 2020.

Starpharma's(https://starpharma.com/)interim results in Stage IV prostate

cancer show that one or more efficacy signals[2] were observed in 100% of

patients assessed following DEP(R) cabazitaxel treatment.

- 64% of patients with assessable tumours saw prolonged stable disease and

significant reductions in tumour size for up to 36 weeks

- 90% of patients with assessable PSA(Prostate Specific Antigen)tumour

biomarker levels had a PSA reduction; >50% of these patients achieved a PSA

reduction of at least 50%

- 83% of patients with secondary bone disease exhibited either no progression

or an improvement in bone disease

- 56% of evaluable patients had responses to all three measures evaluated

Starpharma's positive interim results(https://starpharma.com/news/636)are

particularly significant given all patients in this cohort had late-stage

prostate cancer and had failed multiple anti-cancer treatments, in addition to

surgeries and radiation, prior to entering the DEP(R) cabazitaxel trial.

Importantly, patients treated with DEP(R) cabazitaxel also experienced less

severe bone marrow toxicity, significantly lower rates of severe neutropenia

and no instances of neutropenic sepsis, which are associated with conventional

cabazitaxel. The absence of detergent-like polysorbate-80 in the DEP(R)

cabazitaxel formulation eliminated the need for prophylactic corticosteroids

and antihistamines, with no anaphylaxis or severe hypersensitivity reactions

observed. This avoidance of long-term steroid use is attractive, particularly

in prostate cancer patients where bone health can be a significant issue.

DEP(R) cabazitaxel is one of Starpharma's three internal clinical-stage DEP(R)

assets, alongside DEP(R) docetaxel and DEP(R) irinotecan, which Starpharma

intends to licence following phase 2. Starpharma also has a number of partnered

DEP(R) programs including with AstraZeneca and Merck & Co., Inc.

[1] Polysorbate 80 is a detergent-like substance, which is used to solubilise

insoluble molecules, and which is a component of conventional cabazitaxel

products, including Jevtana(R) and generic forms.

[2] Efficacy in the prostate cancer cohort in the trial was assessed

referencing the applicable aspects of the internationally recognised Prostate

Cancer Working Group (PCWG3) guidelines.

Source:Starpharma