NeoPharm to Launch New Transfection Agent Using Novel Cationic Cardiolipin

Date : 11/13/2003 @ 7:00AM
Source : PR Newswire
Stock : Neopharm (MM) (NEOL)
Quote : 0.1362  0.0062 (4.77%) @ 2:52PM
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NeoPharm to Launch New Transfection Agent Using Novel Cationic Cardiolipin

NeoPharm to Launch New Transfection Agent Using Novel Cationic Cardiolipin NeoPhectin(TM) Commercial Availability Planned for January 2004

LAKE FOREST, Ill., Nov. 13 /PRNewswire-FirstCall/ -- NeoPharm, Inc. announced today the development of NeoPhectin(TM), a novel in vitro transfection reagent that is an outgrowth of the Company's lipid development program and uses NeoPharm's proprietary cationic (positively charged) cardiolipin technology. NeoPhectin(TM) is expected to be available from independent distributors beginning in January 2004 for use in laboratories conducting research that requires use of a transfection reagent. The Company also plans to introduce a novel in vivo transfection reagent, NeoPhectin-AT(TM), for use in laboratories and research facilities for animal testing in March of 2004. Cationic cardiolipin and NeoPhectin(TM) are proprietary products developed by NeoPharm at its Waukegan, Illinois research and development facility. For more information about NeoPhectin(TM), please visit the Company's NeoPhectin(TM) website at http://www.neophectin.com/.

"The introduction of NeoPhectin(TM) is an exciting milestone for NeoPharm," said James M. Hussey, NeoPharm's President and Chief Executive Officer. "While we remain focused on our anti-cancer compounds currently in clinical development, we will continue to look for opportunities to leverage our NeoLipid(TM) platform for the overall benefit of the Company and our shareholders. We believe that cationic cardiolipin may also have potential for use in the treatment of several diseases including infectious diseases, auto-immune diseases and cancer."

In vitro studies conducted at leading research academic centers have demonstrated that NeoPhectin(TM) provides enhanced transfection when compared to a commonly used commercially available transfection reagent in a variety of cell types. NeoPhectin(TM) was also able to deliver RNAi molecules into primary cells in studies conducted at a leading university. To date, a total of 12 academic centers have either completed testing or are conducting independent studies with NeoPhectin(TM). This information will be updated on the NeoPhectin(TM) website ( http://www.neophectin.com/ ) as it becomes available.

In recent animal studies a cationic cardiolipin-based liposome was shown to be less toxic and more effective than another cationic lipid-based liposome formulation of the same anti-cancer compound. "During the last few years, our lipid research program has focused on discovering and developing novel cationic cardiolipin analogues as an essential component of our NeoLipid(TM) technology. These cationic cardiolipin liposomes have the potential to deliver DNA/RNA in both in vitro and in vivo applications," said Dr. Imran Ahmad, NeoPharm's Chief Scientific Officer.

NeoPhectin(TM) Marketing Program

To introduce NeoPhectin(TM) to the research community NeoPharm is conducting a free trial program for qualified researchers until December 31, 2003. Researchers interested in obtaining a complimentary sample vial of NeoPhectin(TM) for testing in their labs may register at http://www.neophectin.com/ .

In order to maintain the Company's primary focus on the development and commercialization of anti-cancer drugs in humans, the Company intends to distribute NeoPhectin(TM) through a network of independent distributors. The Company does not plan to create an internal marketing or sales force for NeoPhectin(TM) at this time.

Background Information

Transfection Market

The transfer of genetic material into the eukaryotic (animal and human) cells is called transfection. This is an important step in several therapeutic applications where the genetic material is introduced into the cells with the aim of preventing, diagnosing, or curing a disease. Several techniques have been developed to transfect cells, which can be classified as either viral or non-viral systems. Even though viral systems are most efficient, irreversible incorporation of genes into the host cell genome may have long-term side effects, including cancer. Viral systems are difficult to establish and may also cause immunogenicity when used for in vivo applications.

As an alternative to viral systems, cationic liposomes are the most commonly used systems for transfection among the non-viral options. The commercially available cationic liposomes do, however, have some disadvantages, although these disadvantages are different than the viral systems. While cationic liposomes form spontaneous complexes with DNA or RNA, and have shown greater transfection efficiency for in vitro use, they have not been effective for in vivo applications. Cationic liposomes usage has been limited due to the toxicity and variable transfection efficiency in different cell lines. The Company believes that cationic liposomes have market potential in DNA/RNA therapy if a successful system can be developed. DNA/RNA therapy may eliminate several in-born genetic defects resulting from the absence or modification of genes due to the alteration of proteins essential for various cell functions.

The syntheses of novel cationic cardiolipin-based lipids at NeoPharm lead to the development of NeoPhectin(TM), a next generation transfection reagent.

NeoPhectin(TM) has small, stable, homogeneous, ready-to-use liposomes that have shown less toxicity to cells and is able to transfect various cell types including primary cells (explanted directly from donor organisms).

How NeoPharm's Proprietary NeoLipid(TM) Delivery Technology Works

Liposomes are microscopic membrane-like structures created from lipids (fats).

They take advantage of tumor cells need to consume large amounts of fats to sustain the tumor's extremely fast growth. NeoPharm's NeoLipid(TM) technology combines drugs or compounds with proprietary lipids, such as cardiolipin. In its natural form, cardiolipin occurs as a negatively charged lipid found in cardiac and muscle tissue. Cardiolipin plays a vital role in mitochondria and electron transport system and signal transduction. It appears to have a role in restoring normal cell functions including apoptosis. Tumor cells recognize the NeoLipid(TM) liposomal drug as a potential source of nutrition, which allows the active drug to be delivered directly to the tumor cell. In addition, NeoLipid(TM) technology allows for the creation of a stable liposome. This physical property is especially important during drug storage and after the product has been reconstituted and administered intravenously to the patient.

Based on NeoPharm's research to date, NeoLipid(TM) formulations have demonstrated an ability to reduce the toxicity of potent chemotherapeutic drugs, making for the possibility of a more comfortable to administer, safer, and well-tolerated treatment for cancer patients.

About NeoPharm

NeoPharm, Inc., based in Lake Forest, Illinois, is a publicly traded biopharmaceutical company dedicated to the research, development and commercialization of new and innovative cancer drugs for therapeutic applications. The Company has a broad portfolio of cancer compounds in various stages of development. Additional information about NeoPharm and recent news releases can be obtained by visiting NeoPharm's Website at: http://www.neophrm.com/ .

Forward Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as "expects," "intends," "hopes," "anticipates," "believes," "could," "may," "evidences" and "estimates," and other similar expressions, but these words are not the exclusive means of identifying such statements. Such statements include, but are not limited to, any statements relating to the Company's drug development program and any other statements that are not historical facts including information on the introduction of new non-drug products including NeoPhectin(TM) to the scientific community, the ability of independent distributors to develop a market for NeoPhectin(TM), and the ability to introduce additional non-drug products thereafter. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of the Company's drug and non- drug compounds, uncertainty regarding the availability of third party lyophilization capacity, uncertainty regarding the outcome of damage claims made by or against the Company, including the outcome of the pending arbitration with Pharmacia, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug and non-drug compounds that could slow or prevent products coming to market, the uncertainty of patent protection for the Company's intellectual property or trade secrets and other risks detailed from time to time in filings the Company makes with the Securities and Exchange Commission including our annual reports on Form 10-K and our quarterly reports on Forms 10-Q. Such statements are based on management's current expectations, but actual results may differ materially due to various factors, including those risks and uncertainties mentioned or referred to in this press release. Accordingly, you should not rely on these forward-looking statements as a prediction of actual future results.

DATASOURCE: NeoPharm, Inc.

CONTACT: Larry Kenyon, CFO of NeoPharm, +1-847-295-8678, or Investor

contact, Janet Dally of MontRidge, LLC, +1-203-894-8038

Web site: http://www.neophectin.com/

http://www.neophrm.com/

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