Clinical Trials

Date: 2014-03-21

Type of information: Results

phase: 2a

Announcement: results

Company: LIDDS (Sweden)

Product: Liproca® Depot

Action mechanism: Liproca® Depot is an injectable modified release product that successfully has been developed for local antiandrogen therapy of prostate cancer. The company presents the data at the 26th Annual Congress of the European Association of Urology (EAU) in Vienna.

Disease: localized prostate cancer

Therapeutic area: Cancer - Oncology

Country:

Trial details:

• • On March 21, 2014, LIDDS announced that results from the recently finalized clinical phase IIa study with Liproca® Depot  in patients with localized prostate cancer (scheduled for prostatectomy) will be presented by Prof. Teuvo Tammela, Tampere University Hospital, at the EAU-meeting in Stockholm, Sweden on April 14, 2014. The results demonstrate:
• - Local and specific antiandrogen effect confirmed by MRSI (Magnetic Resonance Spectroscopy Imaging) on both malign and benign prostate cells globally (i.e. throughout the whole gland)
• - More rapid onset of reduction of PSA for Liproca® Depot  (920 mg single intraprostatic dose of 2-hydroxyflutamide, “2-HOF”) than oral flutamide* (750 mg/day)
• - Increased effect on PSA and prostate volume at 1 month after injection of Liproca® Depot  when the dose of 2-HOF was increased from 720 to 920 mg, which indicates a dose response relationship
• - With an increased dose of Liproca® Depot  (e.g. 1840 mg) a PSA reduction (Emax) similar to oral flutamide (750 mg/day) is expected, but with a much more rapid onset of effect. The Emax in PSA reduction for oral antiandrogen and GnRH-analogues is on average 65-70 % and 80 %, respectively.
• - Few and minimal side effects in conformity with earlier clinical studies with Liproca® Depot.
• • On March 19, 2011, LIDDS presented interim data from its phase IIa trial of Liproca® Depot for treatment of localized prostate cancer at the 26th Annual Congress of the European Association of Urology (EAU) in Vienna. Liproca® Depot has demonstrated effect on an established cancer biomarker and has a very low frequency of antiandrogen related side-effects. This is accomplished by delivering sufficiently high drug concentrations in the tumor areas, within the prostate gland, during several months, following one single injection of Liproca® Depot, while avoiding high systemic drug concentration and thus avoiding the antiandrogen related side-effects. The interim data from the phase IIa trial also confirms that there is a clear local antiandrogen response and that the treatment is well tolerated.
• The Swedish MPA supports further clinical development after reviewing the preliminary results from this phase IIa trial.

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