Navigation Links
Cytopia Concludes Phase I Oral Trial for Vascular-Disrupting Agent, CYT997
Date:2/5/2009

MELBOURNE, Australia, Feb.5 /PRNewswire/ -- Cytopia Limited (ASX: CYT) has successfully concluded dose-escalation in its oral Phase I study for CYT997, the company's anticancer vascular-disrupting agent (VDA).

The primary objectives of this safety and tolerability study have been achieved. These were to determine the maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) for the agent when administered orally in capsule form every two weeks to patients with a diverse range of solid tumors. Safety and tolerability data from this study augments data obtained in the company's first Phase I study where CYT997 was administered intravenously. Together, these studies suggest that the CYT997 is a potent and selective VDA which is well tolerated at biologically efficacious doses and is worthy of further investigation as a novel anticancer agent.

"Cytopia has now demonstrated the broad clinical potential of CYT997 in both intravenous and oral forms," said Mr. Andrew Macdonald, CEO. "The oral activity of CYT997 is a key advantage over most other vascular disrupting agents which are administered intravenously. The oral activity of the agent should markedly improve its clinical and commercial value."

The company has already commenced Phase II studies for the intravenous form of CYT997 and intends to undertake similar efficacy studies for the oral presentation. Investigating the safety and efficacy of metronomic dosing, frequent oral administration at a comparatively low, but biologically effective dose, is of particular interest.

This oral trial was partly funded under the company's $A3 million Commercial Ready grant.

Preliminary trial data

CYT997 was generally well tolerated in this study with a maximum tolerated dose in cancer patients of ca 165 mg/m2. This dose resulted in maximal plasma concentrations some twofold higher than those observed in the Phase I intravenous infusion study at a comparable dose, indicating favourable oral absorption.

Three dose-limiting toxicities were observed, namely two cases of significant drug-induced fatigue and one case of hypoxia. Importantly, no significant prolongation of the corrected QT interval (a measure of cardiac conduction) was observed.

Patients entering the trial had advanced cancer that had failed to respond to other therapies or for which no other therapy exists. Each was eligible to receive a maximum of six cycles of CYT997 therapy, subject to clinical status. One patient continued to receive the drug beyond their initial six cycles due to prolonged disease stabilisation. No patients currently remain on study.

Secondary objectives of this Phase I study included the determination of a recommended dose for Phase II studies and pharmacokinetic assessment and a preliminary investigation of the anti-tumor properties of CYT997. Analysis of biological and clinical data from the study is currently ongoing and the company expects to present a finalized trial report, including a complete list of adverse events and the recommended dose for Phase II studies, within three months.



    The following table provides a summary of the key aspects of this trial.

    -------------------------------------------------------------------------
    Name of Trial                   An accelerated dose-escalation study of
                                    CYT997 given as an oral capsule every two
                                    weeks in patients with advanced solid
                                    tumors (CCL06001).
    -------------------------------------------------------------------------
    Primary Endpoints               Determination of the dose-limiting
                                    toxicities and maximum tolerated dose of
                                    CYT997 given as an oral capsule dose.
    -------------------------------------------------------------------------
    Secondary Endpoints             Pharmacokinetics; definition of
                                    recommended dose for Phase II studies;
                                    preliminary evaluation of vascular-
                                    targeting activity.
    -------------------------------------------------------------------------
    Blinding Status                 Not blinded.
    -------------------------------------------------------------------------
    Product Development Status      Drug substance and drug product are
                                    manufactured to GMP standards.
    -------------------------------------------------------------------------
    Treatment Method
            Route                   Oral
            Frequency               Two weekly cycle
            Dose-levels             Dose-escalation study over 8 dose-levels
                                    (15 to 164 mg/m2)
    -------------------------------------------------------------------------
    Number of Trial Subjects        21
    -------------------------------------------------------------------------
    Subject Selection Criteria      Eligible patients must have a solid tumor
                                    that is metastatic or unresectable for
                                    which standard therapies do not exist or
                                    are no longer effective.
    -------------------------------------------------------------------------
    Trial Locations                 Adelaide, Brisbane, and Townsville,
                                    Australia.
    -------------------------------------------------------------------------
    Trial Standard                  ICHGCP
    -------------------------------------------------------------------------

About Cytopia

Cytopia Ltd is an Australian biotechnology company discovering and developing new drugs to treat cancer and other diseases. Cytopia conducts its research and drug development through subsidiaries based in Melbourne, Australia and San Francisco, USA and specializes in developing new small molecule compounds with an improved therapeutic profile for the treatment of cancer.

The company's lead drug candidate is CYT997, a vascular disrupting agent (VDA) for the treatment of various cancers. It is currently being trialled in Phase II clinical studies. Cytopia is continuing to build on its range of JAK inhibitors and kinase expertise. CYT387, a novel, orally administered JAK2 inhibitor focused on the treatment of myeloproliferative disorders is expected to enter Phase I clinical studies in 2009.


'/>"/>
SOURCE Cytopia Limited
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Cytopia Scientific Presentations on JAK2 Inhibitor Program
2. Cytopia Commences Second Phase II Study in Brain Cancer
3. Cytopia Appoints Study Chairman for JAK2 Clinical Trial
4. Release of Cytopia Abstract for CYT997 Oral Presentation at American Society of Clinical Oncology
5. Cytopia Announces Novel Anti-Cancer Drug Development Collaboration
6. Cytopia Nominates JAK2 Clinical Candidate for Myeloproliferative Disorders
7. Walter Reed Evaluation Concludes FirstVue(TM) HBSAG Test is Preferred over Other Rapid Tests
8. Pivotal Pulmonary Arterial Hypertension Study Published in The Lancet Concludes That Bosentan (Tracleer(R)) Demonstrates Benefits in Patients With Mildly Symptomatic WHO Functional Class II Disease
9. Pharmaxis Concludes Special Protocol Assessment with FDA for Bronchitol Phase 3 Trial
10. Alseres Pharmaceuticals Concludes Enrollment in the Cethrin(R) Phase I/IIa Clinical Trial in Acute Spinal Cord Injury
11. FDA Concludes There is No Increased Risk of Cardiac Events for Patients Treated with omeprazole and NEXIUM(R) (esomeprazole magnesium)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... and SEOUL, South Korea ... Biosys­tems Menarini and Macrogen, Inc. today announced they ... and innovative procedures for precision medicine in cancer. ... Silicon Biosystems, DEPArray™ digital-sorting technology with Macrogen,s high-throughput ... tests certified under the Clinical Laboratory Improvement Amendments ...
(Date:2/12/2016)... Feb. 12 2016  OMS Supply, a large provider ... practitioners, announced today the recent launching of their new ... variety of features that enhance the user experience and ... --> --> ... new company that started in early 2016, they have ...
(Date:2/12/2016)... 12, 2016 Indiso ... den ungedeckten medizinischen Bedarf bei Lungen- und ... klinischen Forschungsprogramms bekannt. Das Programm, das sich ... ihrer respiratorischen Funktionen und anderer klinischer Parameter. ... Medizintechnikunternehmen, das sich auf den ungedeckten medizinischen ...
Breaking Medicine Technology:
(Date:2/12/2016)... ... February 12, 2016 , ... ... new initiative—the Siemens Foundation-PATH Ingenuity Fellowships—to develop the advanced skills needed to ... students from U.S. universities who will draw from Siemens’ deep knowledge of ...
(Date:2/12/2016)... ... ... , Back to the Future , Feb. 25, 2016 — 11:00 a.m. – 12:30 p.m. ... learn from history are doomed to repeat it.” , An analysis of CDRH’s enforcement actions ... takes time. , Take a close look at the warning letters the agency sent ...
(Date:2/12/2016)... ... ... Each year, the American Physical Therapy Association (APTA) offers a Combined Sections ... Center. Almost 10,000 physical therapists across the country are expected to attend this annual ... chosen field and network with their colleagues. As in years past, HydroWorx is ...
(Date:2/12/2016)... ... February 12, 2016 , ... Coco Libre, the maker of coconut ... Events LA GRAMMY’s Style Lounge Event. Coco Libre will offer musicians and celebrities the ... the big event. The invitation-only gifting suite, held this year at the W Hollywood ...
(Date:2/12/2016)... ... 2016 , ... The ThedaCare Center for Healthcare Value is ... April 5-7. The series is a multi-day, multi-workshop event designed to teach leaders ... broad range of topics, including coaching skills, the scientific method of problem solving ...
Breaking Medicine News(10 mins):