SOURCE: Oncologix Tech Inc.

April 10, 2007 13:37 ET

Oncologix Tech Inc. Announces Plans to Conduct a Feasibility Clinical Study on the Oncosphere System

GRAND RAPIDS, MI -- (MARKET WIRE) -- April 10, 2007 -- Oncologix Tech Inc. (OTCBB: OCLG) announced today that its wholly owned subsidiary Oncologix Corporation ("Oncologix") has decided to update its development plans to add a Feasibility Clinical Study with its Oncosphere System for the treatment of liver cancers. Oncologix plans to submit a request for approval from the Food and Drug Administration (FDA) to conduct the Feasibility Clinical Study before the end of 2007.

The Feasibility Clinical Study will be conducted under approval of an Investigational Device Exemption (IDE) by the FDA and is anticipated to provide data on human patients as early as February 2008, one year earlier than the data available from the Pivotal Clinical Trial under the original plan. The purpose of a Feasibility Clinical Study is to provide preliminary safety data in a smaller group of patients to fulfill FDA requirements for submission and approval of a larger Pivotal Clinical Trial.

Dr. Andrew Kennedy, MD, FACRO, Oncologix's Chief Science and Medical Officer, will participate as the Principal Investigator for the Feasibility Clinical Study and treat patients in the study at his medical center in North Carolina. The study will include the treatment of ten to twenty patients with solid tumors in the liver at a total of two to four medical centers experienced in treatment with radioactive microspheres.

The Feasibility Clinical results will be used to support the company's request for FDA approval of the IDE for the Pivotal Clinical Trial with the Oncosphere System. A Pivotal Clinical Trial is a definitive study designed to evaluate Safety and Effectiveness and is required for commercial approval by the FDA. The new plan schedules the Feasibility Clinical Trial to be conducted before the Pivotal Clinical Trial. The Pivotal Clinical Trial will now have an anticipated FDA approval in April 2008.

According to Andrew Green, CEO of Oncologix Corporation, "The human feasibility study will provide clinical results with the Oncosphere product approximately one year earlier than the previous plan. This will allow our physician advisors, the FDA, and our shareholders to gain the best understanding of the Oncosphere product as early as possible."

Additionally, Oncologix Corporation announced that it has successfully completed treatment of the first phase of the animal studies with the Oncosphere System. The study, conducted at the Institut de Cardiologie de Montréal (Montreal Heart Institute), was designed to evaluate the feasibility of the system and analyze the distribution of the Oncopsheres in the liver vasculature with a non-radioactive version of the product. The second phase is anticipated to begin in early summer 2007 and will evaluate the safety and feasibility of radioactive Oncopsheres in an animal model. Once completed, the two studies will be included in the IDE to the FDA requesting approval to begin the Feasibility Clinical Study.

About Oncologix Tech Inc. (A Development Stage Company) and Oncologix Corp.:

Oncologix Tech Inc. (formerly BestNet Communications Corp.) was formerly a provider of long distance telephone communication services. During February 2007, the Company completed the disposition of its telephone business segment.

Oncologix Corporation, based in Atlanta, GA, is a wholly owned subsidiary of Oncologix Tech Inc. Oncologix is developing advanced medical treatments for soft tissue cancers; the Oncosphere System. The Oncosphere System is a brachytherapy (radiation therapy) device being developed for the treatment of soft tissue cancers. It is based on a radioactive micro-particle designed to deliver therapeutic radiation directly to a tumor site by introducing the micro-particles into the artery that feeds the tumor tissue.

This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by the "safe harbor" created thereby. These statements include the plans and objectives of management for future operations, including plans and objectives. The forward-looking statements herein are based on current expectations that involve judgments with respect to, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond control of the company. Although the company believes that the assumptions underlying the forward-looking statements are reasonable, any one of the assumptions could be inaccurate and, therefore, can be no assurance that the forward-looking statements included in this release will prove to be accurate.

Contact Information

  • Contact:
    Michael A. Kramarz
    Phone: 616.977.9933