ANTI-CANCER HOPES HAVE A SOLID SOLUTION

Recent publicity of the anti-cancer effects of a pre-clinical "drug" treatment, Angiostatin(tm), produced by Rockville's EntreMed, Inc. and licensed by Bristol Myers Squibb, have raised many questions about the prudence of capital markets to respond so strongly to a pre-clinical situation in labeling a recombinant protein as a "cure for cancer". Much attention is focused on the length of time it takes to get a new "drug" through clinical trials and FDA approval. With the tremendous technology advances in bioscience research, one might presume a comfort level with reported success. Scientists agree, however, that thorough validation is a primary goal in development of new drug therapies or delivery systems. One such bioscience company, CytImmune Sciences, Inc., College Park, Maryland, has discovered a novel method to utilize known proteins that manipulate the biological response mechanism of a number of host responses to "drugs" and other disease-causing agents. CytImmune's!

novel methods manipulate the body to both produce, and control, the biological response to these drugs and agents.

In collaboration with EntreMed, Inc., CytImmune Sciences, Inc. is developing a NOVEL DRUG DELIVERY SYSTEM FOR ANGIOGENESIS AND ANTI-CANCER THERAPY. This drug/gene delivery system utilizes unique properties of microscopic gold particles (termed colloidal gold) to carry very potent anti-cancer drugs and genes to their targets, in this case, tumors. One of the drugs/genes that is slated for anti-cancer delivery is Endostatin', with EntreMed working toward completion of pre-clinical studies to allow filing of an Investigational New Drug Application (INDA).

Upon recognition of the potential of colloidal gold, CytImmune Sciences has expanded its use as a human therapeutic. Clinically, colloidal gold has been used to relieve joint inflammation in patients suffering from rheumatoid arthritis. This therapy has been used safely for over 50 years.

Another discovery about how colloidal gold binds to proteins, such as Endostatin(tm), and slowly releases them into very localized areas, (such as tumor sites), poses further inquiry into anti-cancer possibilities. Maintaining high levels of Endostatin' at the tumor site may be just the right means for achieving localized anti-angiogenesis that will restrict tumor cell growth . In addition, colloidal gold may be used to carry other anti-cancer drugs, whose action is directed on the tumor cells themselves. The combined targeted delivery of anti-angiogenesis factors and anti-cancer agents will then provide a "one-two" knock-out punch on tumors, while sparing normal healthy cells.

CytImmune Sciences has further concluded that colloidal gold may be an ideal vehicle for bringing genetic information into a cell. As applied to anti-cancer therapy, such genetic material may be used for making a specific protein. Once the protein is made it may either act inside the cell or be secreted by the cell. CytImmune Sciences and EntreMed are collaborating to bring the genetic information for the protein Endostatin(tm) inside specific cancer cells.

The study of well-known mechanisms of cell biology has enabled CytImmune Sciences to capitalize on existing biological responses to these, and other, delivered agents. On every cell there are many locks, called receptors. For every lock there is a unique key, also a specific protein. CytImmune Sciences has identified specific keys, or proteins, and attached them to colloidal gold particles that already carry a specific gene.

They have then determined that the carried gene is incorporated into specific cells by detecting the gene's encoded protein. In effect, the colloidal gold acts like a "Trojan horse" bringing information from outside the cell to the inside.

CytImmune Sciences and EntreMed plan to conduct animal experiments designed to carry the Endostatin(tm) gene into melanoma tumor cells and determine if the local secretion of Endostatin(tm) is sufficient to induce anti-angiogenesis. The gene delivery of Endostatin' will be proof of the concept that broad-based application of colloidal gold as a novel drug/gene delivery system has a viable future.

CytImmune Sciences is a ten year old, (10), privately held company located in College Park, MD. The company was founded by Lawrence Tamarkin, Ph.D., former Chief and faculty at NIH and UMD, and develops, manufactures and sells 43 different immunoassay kits to measure cytokines in cell cultures or in biological fluids. Cytokines are the chemical communication signals of the immune system, and CytImmune has developed a patented cytokine detection system that accurately measures these proteins in biological fluids, such as blood. The company is also applying its patented assay technology to develop immunoassays for both anti-angiogenic factors, Angiostatin(tm) and Endostatin(tm). This development work is being done in collaboration with EntreMed, Inc.

For additional information about Cytimmune's role in anti-cancer therapy, call Niki Faldemolaei, Publicist, at 301-365-7320, e-mail: [email protected], Lawrence Tamarkin, Ph.D., at (301)-445-4370 or visit CSI's web site at http://www.cytimmune.com

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