Printer Friendly
The Free Library
14,505,492 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

OXiGENE Announces Interim Results of Wet Age-Related Macular Degeneration Trial of Combretastatin A4 Prodrug.


Business Editors/Health/Medical Writers

2nd International Conference on Vascular Targeting

WALTHAM, Mass.--(BUSINESS WIRE)--May 18, 2004

Data Presented to 2nd International Conference on Vascular Targeting

OXiGENE, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: OXGN, XSSE: OXGN) today announced that interim results from the Phase I/II clinical trial of Combretastatin A4 Prodrug (CA4P) in patients with wet age-related macular degeneration Age-related macular degeneration (ARMD)
Degeneration of the macula (the central part of the retina where the rods and cones are most dense) that leads to loss of central vision in people over 60.
 (wet AMD (Advanced Micro Devices, Inc., Sunnyvale, CA, www.amd.com) A major manufacturer of semiconductor devices including x86-compatible CPUs, embedded processors, flash memories, programmable logic devices and networking chips. ) were presented at the 2nd International Conference on Vascular Targeting. The study's co-investigator, Peter Campochiaro, M.D., professor of ophthalmology at Johns Hopkins University Johns Hopkins University, mainly at Baltimore, Md. Johns Hopkins in 1867 had a group of his associates incorporated as the trustees of a university and a hospital, endowing each with $3.5 million. Daniel C.  School of Medicine's Wilmer Eye Institute, presented the data Tuesday at the 2nd International Conference on Vascular Targeting in Miami Beach, Florida “Miami Beach” redirects here. For the beach in Barbados, see Miami Beach, Barbados.
See also:
Miami Beach is a city in Miami-Dade County, Florida, United States.
.

Seven patients have received treatment with CA4P in this dose escalation pilot study, including one patient on the first dose level who experienced objective biological response to the investigational drug as measured by optical coherence tomography Optical coherence tomography (OCT) is an interferometric, non-invasive optical tomographic imaging technique offering millimeter penetration (approximately 2-3 mm in tissue) with micrometer-scale axial and lateral resolution.  (OCT OCT ornithine carbamoyltransferase; oxytocin challenge test.

OCT

ornithine carbamoyl transferase, a liver specific enzyme.

OCT Oxytocin stress test, see there
). The area of choroidal cho·roi·dal
adj.
Of or relating to the choroid.



choroidal

pertaining to or emanating from the choroid.


choroidal hypoplasia
 neovasculariztion (CNV CNV Choroidal Neovascularization (eye disorder)
CNV Christelijk Nationaal Vakverbond
CNV Copy Number Variation
CNV Conveyor
CNV Chief of Navy
CNV Continuous Normal Voltage
CNV Crypto Net Variable
CNV Could Not Verify
) in the patient's study eye decreased by approximately 100 microns, a reduction that Dr. Campochiaro said was "not within the realm of spontaneous changes." CNV occurs when abnormal blood vessels Blood vessels

Tubular channels for blood transport, of which there are three principal types: arteries, capillaries, and veins. Only the larger arteries and veins in the body bear distinct names.
 sprout behind the retina, leaking blood and other fluid into the retina and triggering the sudden and severe central vision loss known as wet AMD.

Dr. Campochiaro reported that CA4P has been well tolerated up to doses of 36 mg/m2 and the side effects Side effects

Effects of a proposed project on other parts of the firm.
 observed were increased blood pressure and pulse and an increase in QTc interval below clinical significance. No serious or dose-limiting adverse events were reported.

In addition, a 35-year-old patient with myopic macular degeneration macular degeneration, eye disorder causing loss of central vision. The affected area, the macula, lies at the back of the retina and is the part that produces the sharpest vision.  experienced a significant improvement in visual acuity visual acuity
n.
Sharpness of vision, especially as tested with a Snellen chart. Normal visual acuity based on the Snellen chart is 20/20.


Visual acuity
The ability to distinguish details and shapes of objects.
 after he received CA4P treatment at The Wilmer Eye Institute under a special exemption from the U.S. Food and Drug Administration. Prior to beginning a regimen of CA4P treatments, the patient had visual acuity of 20/50 in the study eye with active leakage in both eyes that had persisted following other treatment approaches. After the patient was treated with the systemically administered CA4P, his vision was restored to 20/20 with significantly reduced leakage in each eye.

"While significant data must still be collected in this study, the interim results regarding biological activity and safety are quite promising," said Dai Chaplin, Ph.D., OXiGENE's chief scientific officer and head of research and development. "This is particularly true given that the study is a Phase I/II trial principally designed to demonstrate proof of concept. Dr. Campochiaro's presentation complements the numerous pre-clinical tests that illustrate the ability of CA4P to inhibit development and promote regression of CNV."

Dosing is underway in the second of three patient cohorts that have been established to evaluate CA4P at 27, 36 and 45 mg/m2. The compound is being assessed for safety, tolerability, dose-limiting toxicities and potential efficacy. A total of 15 patients are expected to be enrolled in the trial. Wet AMD is the leading cause of severe vision loss among Americans over age 60. The disease affects approximately 2 million to 3 million in the U.S.

This year, OXiGENE plans to expand its clinical program in ophthalmology by initiating a clinical study in patients with myopic macular degeneration. As part of the expansion of its ophthalmology program, the Company is pursuing local, non-systemic methods of administering its vascular targeting agents to the posterior segments of the eye. While instances of hypertension were noted in the Phase I/II study by Dr. Campochiaro, he indicated that a local method of delivery could substantially reduce systemic exposure to CA4P and further improve its safety profile in this clinical setting.

Also during Tuesday's presentation, Dr. Campochiaro discussed his pre-clinical work with CA4P, published last year in the peer-reviewed journal peer-reviewed journal Refereed journal Academia A professional journal that only publishes articles subjected to a rigorous peer validity review process. Cf Throwaway journal.  Investigative Ophthalmology and Visual Science. Dr. Campochiaro and his colleagues at Johns Hopkins conducted experiments on transgenic mice with CNV caused by an over expression of vascular endothelial growth factor Vascular endothelial growth factor (VEGF) is an important signaling protein involved in both vasculogenesis (the de novo formation of the embryonic circulatory system) and angiogenesis (the growth of blood vessels from pre-existing vasculature).  in the retina and mice with laser-induced rupture of Bruch's membrane Bruch's membrane
n.
See basal layer.


Bruch's membrane
A membrane in the eye between the choroid membrane and the retina.
. In both groups of animals, daily intraperitoneal injections of CA4P resulted in a "significant reduction" in established CNV, putting the compound "in select company," he reported.

About the Conference on Vascular Targeting

The 2nd International Conference on Vascular Targeting is a scientific meeting of cancer researchers representing pharmaceutical companies, universities, medical institutions and non-profit organizations from around the world. The event is scheduled to feature more than 40 presentations highlighting current scientific research and the therapeutic potential of vascular targeting as a treatment for solid tumor cancers and ocular diseases.

About OXiGENE

OXiGENE is the world leader in the development of vascular targeting agents (VTAs), novel biopharmaceutical compounds designed to selectively target and destroy new blood vessels. The Company's lead compound, Combretastatin A4 Prodrug (CA4P), is in clinical development in patients with solid tumor cancers and wet age-related macular degeneration. Three other OXiGENE VTAs, OXi4503, OXi6197 and OXi8007, are in pre-clinical development. For more information about OXiGENE, visit www.oxigene.com.

Safe Harbor Statement

Statements in this news release concerning the presentation of interim clinical results from the Phase I/II study of CA4P in wet AMD are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. These include, but are not limited to, statements about the expected dosing regimen; the anticipated enrollment of 15 patients in the trial; OXiGENE's plan to initiate a clinical study in myopic macular degeneration in 2004; and the expectation that development of a local, non-systemic formulation of CA4P could substantially reduce systemic exposure to the compound and improve its safety profile in the relevant clinical setting. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions OXiGENE might make or by known or unknown risks and uncertainties, including, but not limited to: the early stage of product development; the ability to secure necessary patents; uncertainties as to the future success of ongoing and planned clinical trials; and the unproven safety and efficacy of products under development. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements are contained in OXiGENE's reports to the Securities and Exchange Commission, including OXiGENE's 10-Q, 8-K and 10-K reports. However, OXiGENE undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise.
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Geographic Code:1USA
Date:May 18, 2004
Words:1059
Previous Article:Natural Health Trends Corp. to File Extension for First Quarter Results.
Next Article:Schaeffer's Street Chatter Highlights the Following Stocks: Home Depot, Millennium Pharmaceuticals, and Stelmar Shipping.
Topics:



Related Articles
Physicians find clues to vision deterioration.(research on age-related macular degeneration)(Brief Article)
Photodynamic treatment used on eyes.(new treatment for wet macular degeneration)(Brief Article)
OXiGENE Announces Launch of Ophthalmic Clinical Trial at The Johns Hopkins University School of Medicine.
OXiGENE to Present at CIBC World Markets' 14th Annual Healthcare Conference; November 12th Presentation Available via Live Webcast.
OXiGENE Launches Significant Expansion of its R&D Program in Ophthalmology.
OXiGENE Announces Issuance of U.S. Patent for Improved Compositions of Combretastatin A4 Prodrug.
OXiGENE's Combretastatin A4 Prodrug Granted European Union Orphan Medicinal Product Designation for Anaplastic Thyroid Cancer.
OXiGENE to Present at Friedman Billings Ramsey's 8th Annual Growth Investor Conference; June 2nd Presentation Available via Live Webcast.
OXiGENE Issues Statement Regarding Erroneous Report On ClinicalTrials.gov Website.
Improving the view: treatment reverses macular degeneration.(ranibizumab)

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles