In the first suite of Phase II clinical studies for its “vascular disrupting agent (VDA)”, “CYT997” the dosing of patients has been commenced by ‘Cytopia Limited’. The activity of this anti-cancer compound in specific cancer types which are highly unmet medical need and poor diagnosis will be investigated by these studies.
In the treatment of vascular tumors VDAs are a new class of drugs to treat cancer and have the potential for best sales. A dual action mechanism of CYT997 shuts down the established blood vessels that supply nutrients and oxygen to the tumor and also direct cyto-toxic properties. The compound was discovered by Cytopia scientists in 2003 can be administered orally as well as intravenously. To commence Phase I study an Investigational New Drug application was accepted by the US Food and Drug Administration in 2005.
Cytopia commences dosing in its first Phase II study, finalized preparations for its second Phase II study, concluded its first Phase I safety and tolerability study with intravenous administration and continued dose-escalation in its Phase I capsule dosing study during the 2008 financial year.
Clinical Programs
After the conclusion of its initial Phase I study ‘Cytopia’ commenced dosing in it first Phase II trial in patients with refractory or relapsed multiple myeloma in January 2008. An extensive body of preclinical studies including studies in cells from heavily pre-treated patients was followed by this clinical study. In this clinical study ‘CYT997’ established the significant anti-myeloma activity. The utility of the drug further is the main point of the Phase II studies in conventional solid tumors is extended by the potential activity of this compound in the multiple myeloma. Cytopia also aims to file an Orphan Drug Designation application in the US which gives development benefits including extended patent protection and increased regulatory consultation for this drug in multiple myeloma within 3 months.
Trial in GBM
During the second quarter of 2008 Cytopia is on schedule to commence a Phase II study for CYT997 in ‘Glioblastoma Multiforme (GBM)’ in combination with two other approved anti-cancer agents in order to administer the CYT997.
GBM can be treated with radiotherapy, surgical resection, and chemotherapy. It is an aggressive brain tumor. Many patients’ decline and later have very poor prognosis. In treating this condition GBM blood vessels have shown hope. In this setting, Cytopia aims to investigate the activity of CYT997.
While giving standard chemotherapy, this clinical study will primarily investigate the better safe dose for CYT997. The efficiency study will begin in a two-stage design with scheduled interim examination.
To detect changes in tumor blood vessels as a marker for CYT997 activity the study will also use advanced imaging techniques like specialized MRI. By June 2009 the interim data will be available and in late 2009 the final data.
Testing With Mesothelioma Patients
The company is doing possible examination for a Phase II study in mesothelioma patients, who have failed ‘Alimta’, the currently approved drug which is following the positive findings in mesothelioma patients. The fast approval of the drug can be made by the activity in second-line mesothelioma and a fast market plan for the compound in this cancer indication.
By including randomized studies in conditions such as melanoma ‘Cytopia’ is continuing to refine its clinical development plan for further Phase II studies in consultation with its clinical advisory board.
Oral Capsule Study
In Phase- I oral capsule safety and tolerability study during the past 6 months, Cytopia has continued to accelerate dose-escalation. The compound is well tolerated following oral administration and further increase in the dose of CYT997 is necessary, suggested by the data collected from this study.
Cytopia is finalizing ethical approval for the study leading cancer centers in Adelaide and Melbourne and expect to begin dosing at these new sites in the next four weeks given the expanded patient enrolment. Addition of the two new trial centers will further accelerate dosing in this study. For the company’s Phase II program this initiation of clinical centers widens the company’s clinical partners and lays a foundation.
Intravenous Infusion Study
This study was successfully concluded in September 2007 as previously reported. The findings from this study have guided the design and implementation of the company’s Phase II study program. In June 2008 data from the Phase I study has been accepted for an oral presentation at the 44th ‘American society of Clinical Oncology General Meeting’ in Chicago.
Preclinical Studies
The company will soon begin an expanded program of preclinical combination studies. The preclinical combination studies are designed to determine which currently approved cancer therapies best synergize with CYT997 vascular targeting properties. The data of these studies will assist in the selection and design of later stage clinical programs.
To support its expanded clinical programs the company will also shortly commission synthesis of a third GMP grade batch of CYT997. The preclinical toxicology studies will begin in the next three months. These studies show the company’s ongoing confidence and commitment to the clinical development of CYT997.
In the late stage of clinical studies the development timeline for CYT997 compares favorably with the other vascular disrupting agents. The company aims to finalize the first of its Phase II studies and will two further Phase II studies well established.
Related Links:
This article is the property of http://www.HealthHype.com
Copying and publishing any article from our site is strictly NOT allowed
No user Responded In "A Report on the Clinical Trial of CYT997, the Anti-Cancer Drug"