Tragen Pharmaceuticals focuses on activating cancer-specific immune responses. The company is working on activating the immune system to combat leukemias and lymphomas. Phase II trials have started on Tragen, its top candidate and a treatment for chronic lymphocytic leukemia (www.tragenpharm.com).

CancerVax conducts vaccine research for the treatment of melanoma and colon cancer. Its top candidate is Canvaxin, a vaccine for advanced-stage melanoma. Canvaxin is being evaluated in two Phase III randomized, double-blind, placebo-controlled clinical trials for Stage III and Stage IV melanoma at more than 50 sites worldwide. The vaccine also is being considered for advanced-stage colon cancer treatment. Additional candidates in pre-clinical development include several monoclonal antibodies that appear to inhibit angiogenesis, the blood vessel development that is necessary for tumor growth (www.cancervax.com).

Vical, The Naked DNA Co., focuses on gene therapies for cancer, in which a protein is used as an immune system stimulant or cancer-killing agent. Vical’s immunotherapy Allovectin-7 is in multi-center Phase II clinical trials for patients with advanced melanoma. Vical also is working on DNA vaccines for infectious diseases or cancer, in which the expressed protein is an antigen; and DNA therapeutic protein delivery, in which the expressed protein is a therapeutic agent (www.vical.com).

Maxim Pharmaceuticals’ most advanced anti-cancer candidate is Ceplene, a treatment designed to prevent or inhibit oxidative stress, thereby reversing immune suppression and protecting critical immune cells. Oxidative stress causes tissue damage. In cancer, Ceplene is administered in combination with agents that stimulate immune cells. Ceplene is in late Phase III trials for advanced metastatic melanoma and for acute myelogenous leukemia. It just completed Phase II and is entering Phase III trials for renal cell carcinoma (kidney cancer). Ceplene also may protect or reverse tissue damage caused by free radicals (www.maxim.com).

Epimmune Inc. uses multiple, specific epitopes to activate the body’s immune system. Epitopes, critical signaling molecules, stimulate the T-cell arm of the immune system to respond to specific regions of cancer cells. By combining multiple, selected epitopes into a single drug, the company can design candidates that target specific immune responses and are optimized for strength (www.epimmune.com).

Isis Pharmaceuticals Inc. has four antisense technology-based drugs in clinical development. Isis is manufacturing Affinitac for the product launch period for Eli Lilly and Co. Affinitac, in combination with chemotherapy, is in Phase III clinical trials for the treatment of non-small cell lung cancer. A drug known as ISIS 2503, in combination with chemotherapy, is in Phase II clinical trials for patients with metastatic breast, pancreatic and non-small cell lung cancers. A candidate called OGX-011 is in pre-clinical studies as a single agent and is in combination with chemotherapy for patients with prostate cancer. Also, ISIS 23722 is in pre-clinical development for the treatment of a variety of cancers — the specific cancer to be initially pursued has not been publicly disclosed (www.isip.com).

FeRx Inc.’s lead product, Doxorubicin, is focused on delivering drugs to primary liver tumors and tumors that have metastasized to the liver. The company is developing its proprietary Magnetic Targeted Carrier technology to improve patient care, reduce toxicity and increase efficacy of known drugs for the treatment of cancer. MTCs are microparticles composed of metallic iron and activated carbon that serve as delivery vehicles for the site-specific targeting, retention and release of a variety of pharmaceutical agents, including small molecules, biologics and genetic vectors. Clinical studies under way of MTCs are designed to demonstrate the intra-arterial delivery to specific areas of the body while increasing the concentration of a drug at the target site (www.ferx.com).

Nereus Pharmaceuticals is pursuing sources of chemical diversity in marine microbes, with the goal of providing an uninterrupted pipeline of novel drug candidates to treat diseases such as cancer. The company believes that its microbes could be the next great source of drug discovery for the pharmaceutical industry. Nereus has identified a series of anti-cancer compounds now in preclinical evaluation (www.nereuspharm.com).

Idec Pharmaceuticals Corp. is San Diego’s leader in the discovery, development and commercialization of targeted immunotherapies for the treatment of cancer and autoimmune diseases. Using its method of attaching an antibody to a radioisotope, IDEC’s products can deliver targeted radiation. Idec discovered and developed Zevalin, the first commercially available radioimmunotherapy product, and Rituxan, the first monoclonal antibody product. Both have been approved in the United States to treat non-Hodgkin’s lymphoma. Idec has four product candidates in human clinical trials and three investigational agents in Phase II clinical trials (www.idec.com).

New Biotics Inc. uses its Enzyme Catalyzed Therapeutic Activation technology to develop drugs that have a potent toxin hidden within their chemical structure. The drugs cause the targeted cell to self-destruct with little toxicity to the patient. Thymectacin, the company’s first ECTA drug, treats metastatic colon cancer and has the potential to be applied to many cancers, especially breast cancer (www.newbiotics.com).

Applied Molecular Evolution Inc. optimizes genes and proteins to make existing drugs more convenient and cheaper. The company is working with Medimmune on the drug Vitaxin, which is in two trials for cancer. It is in Phase I for refractory solid tumor patients and in Phase I/II for colorectal patients. AME also has three other drugs still in the preclinical stages. Crucell, a Dutch antibody and vaccine company, has given AME the right to work with other companies for the research and development of monoclonal antibody products produced through AME programs (www.AMEvolution.com).

Neurocrine Biosciences has advanced three programs into clinical trials, including treatments for brain tumors, and kidney, lung, endometriosis and prostate cancers. Most advanced and in Phase II is NBI-3001 for malignant brain tumors. Phase I studies are under way on drugs treating peripheral solid tumors and treatments for kidney, lung, endometriosis and prostate cancers (www.neurocrine.com).

NovaRx Corp. uses antisense gene-modification technology to create vaccines that unmask cancer cells and expose them to the body’s immune system for destruction and prevention of spreading. The company’s most advanced drug, TGF-Beta2 Antisense Gene-Modified Allogeneic Tumor Cell Vaccine, is in Phase II testing for patients with non-curable non-small cell lung cancer. NovaRx also is pursuing vaccines for breast cancer, prostate cancer, colon cancer, melanoma and brain tumors (www.novarx.org).

Ligand Pharmaceuticals and its two product divisions, Ligand Specialty Pharmaceutical Products and Ligand Corporate Partner Products, have approved products for the treatment of cutaneous T-cell lymphoma: Ontak, Targretin capsules and Targretin gel. Research is under way to test the drugs on lung cancer and B- and T-cell non-Hodgkin’s lymphomas. Affinitac, a drug Isis developed to treat non-small cell lung cancer, is in Phase III. Isis 2503, a drug that treats pancreatic, metastatic breast and non-small cell lung cancers, is in Phase II. In the preclinical phases are OGX-011, which treats prostate cancer, and Isis 23722, which treats a variety of cancers (www.ligand.com).

Favrille Inc.’s customized treatment for B-cell non-Hodgkin’s lymphoma is FavId. Patients’ immune systems respond to the FavId treatment by seeing tumors as foreign invaders. FavId is a combination of a tumor specific protein known as the idiotype and a second protein from an ocean mollusk, called keyhole limpet hemocyanin. FavId is in Phase II testing. Torrex, another biologic development, is in Phase I of clinical trials and treats T-cell non-Hodgkin’s lymphoma, like FavId for B-cell. Farville uses personal genomics and recombinant technologies to create treatment for diseases of the immune system, such as cancer of the lymph nodes and white blood cells. First a biopsy is taken from the tumor, then a vaccination is created to specifically fight that tumor (www.favrille.com).

Salmedix Inc.’s clinical-stage compound SDX-101 is in Phase Ib/IIa. It is an oral drug for chronic lymphocytic leukemia, multiple myeloma and lymphoma. SDX-101 was discovered serendipitously as a derivative agent of an existing marketed anti-inflammatory drug during clinical use. It is selectively toxic to cancer cells, while being inactive against normal cells. The company also plans to re-initiate clinical development of SDX-102, using a diagnostic test for patient selection, and will conduct trials in combination with existing anti-cancer agents. New Phase II trials are planned for later this year. A third drug being developed by Salmedix, SDX-103, is in pre-clinical stages. It induces cell death in non-dividing cancer cells that have become resistant to other drugs. The drug also inhibits formation of new blood vessels (www.salmedix.com).