UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

 

FORM 10-K

 

(Mark One)

 

for the transition period from                   to                  .

 

Commission file number: 0-21088

 

VICAL INCORPORATED

(Exact name of registrant as specified in its charter)

 

 

Registrant’s telephone number, including area code:  (858) 646-1100

 

Securities registered pursuant to Section 12(b) of the Act:  None

 

Securities registered pursuant to Section 12(g) of the Act:

Common Stock, $0.01 par value

(Title of Class)

 

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ý  No o

 

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ý

 

Indicate by check mark whether the registrant is an accelerated filer (as defined in Exchange Act Rule 12b-2). Yes ý  No o

 

The aggregate market value of the voting stock held by non-affiliates of the registrant, based upon the last sale price of the Common Stock reported on the National Association of Securities Dealers Automated Quotation National Market System on June 28, 2002, was approximately $94,046,000. Shares of Common Stock held by each officer and director and by each person who owns 10% or more of the outstanding Common Stock of the registrant have been excluded in that such persons may be deemed to be affiliates. This determination of affiliate status is not necessarily a conclusive determination for other purposes.

 

The number of shares of Common Stock outstanding as of March 19, 2003, was 20,091,344.

 

 

DOCUMENTS INCORPORATED BY REFERENCE

 

Specified portions of our Definitive Proxy Statement to be filed with the Securities and Exchange Commission pursuant to Regulation 14A in connection with the solicitation of proxies for our 2003 Annual Meeting of Stockholders to be held on May 21, 2003, are hereby incorporated by reference in Part III of this report.

 

FORWARD-LOOKING STATEMENTS

 

The statements incorporated by reference or contained in this report discuss our future expectations, contain projections of our results of operations or financial condition and include other “forward-looking” information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Our actual results may differ significantly and materially from those expressed or implied in forward-looking statements made or incorporated by reference in this report. Forward-looking statements that express or imply our beliefs, plans, objectives or assumptions, or that describe future events or performance, may involve estimates, assumptions, risks and uncertainties. Therefore, our actual results and performance may differ significantly and materially from those expressed in the forward-looking statements. Forward-looking statements often, although not always, include words or phrases such as the following, or the negative of such words, or other comparable terminology:

 

•                  “will likely result,”

•                  “are expected to,”

•                  “will continue,”

•                  “is anticipated,”

•                  “estimate,”

•                  “believe,”

•                  “predict,”

•                  “potential,”

•                  “intends,”

•                  “plans,”

•                  “projection,” and

•                  “outlook.”

 

You should not unduly rely on forward-looking statements contained or incorporated by reference in this report. Actual results or outcomes may differ significantly and materially from those predicted in our forward-looking statements due to the risks and uncertainties inherent in our business, including risks and uncertainties related to:

 

•                  progress of our preclinical and clinical product development programs,

•                  clinical trial results,

•                  obtaining and maintaining regulatory approval,

•                  market acceptance of and continuing demand for our products,

•                  the attainment of patent protection for any of these products,

•                  the impact of competitive products, pricing and reimbursement policies,

•                  our ability to obtain additional financing to support our operations,

•                  the continuation of our corporate collaborations and licenses,

•                  our ability to enter into new corporate collaborations and licenses,

•                  changing market conditions, and

•                  other risks detailed below.

 

You should read and interpret any forward-looking statements together with:

 

•                  our Quarterly Reports on Form 10-Q,

•                  the risk factors contained in this report under the caption “Additional Business Risks,” and

•                  our other filings with the Securities and Exchange Commission.

 

Any forward-looking statement speaks only as of the date on which that statement is made. We disclaim any duty to update any forward-looking statement to reflect events or circumstances that occur after the date on which such statement is made.

 

2

 

PART I

 

ITEM 1.                                                     BUSINESS

 

Overview

 

We were incorporated in Delaware in 1987. We research and develop biopharmaceutical products based on our patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. In addition, we have gained access to enhancing technologies through licensing and collaborative agreements. We believe the following areas of research offer the greatest potential for our product development efforts:

 

•                  Vaccines for use in high-risk populations for infectious disease targets for which there are significant U.S. needs,

 

•                  Vaccines for general pediatric or adult populations for infectious disease applications for which a challenge model or accepted surrogate marker are available, and

 

•                  Cancer vaccines or immunotherapies which complement our existing programs and core expertise.

 

For opportunities outside these areas, we plan to continue leveraging our patented technology through licensing and collaborations. In addition, we plan to use our expertise, infrastructure, and financial strength to explore in-licensing or acquisition opportunities.

 

We have established relationships through licensing our technology to a number of commercial entities, including:

 

•                  Merck & Co., Inc.,

 

•                  Two divisions of Aventis S.A.:

•                  Aventis Pasteur, and

•                  Aventis Pharmaceuticals Inc.,

 

•                  Merial,

 

•                  Centocor, Inc., a wholly-owned subsidiary of Johnson & Johnson,

 

•                  Invitrogen Corporation,

 

•                  Human Genome Sciences, Inc., and

 

•                  Vascular Genetics Inc., which recently merged into Corautus Genetics Inc.

 

We have also licensed poloxamer technologies from CytRx Corporation.

 

Our Core Technology

 

The key discovery leading to our patented core technology was that muscle tissues can take up polynucleotide genetic material, such as DNA or RNA, directly, without the use of viral components or other delivery vehicles, and subsequently express the proteins encoded by the genetic material for periods ranging from weeks to more than a year. We often describe our approach as “DNA delivery technology” because it typically involves designing and constructing closed loops of DNA called plasmids. These plasmids contain a DNA segment encoding the protein of interest, as well as short segments of DNA that control protein expression. We are able to use uniform methods of fermentation and processing that are applicable to all plasmids. This could result in faster development times than technologies that require development of product-specific manufacturing processes.

 

Since the initial discovery of our DNA delivery technology, our researchers have improved the design of our plasmids to provide increases in efficiency of gene expression and immunogenicity. In addition, we are developing other formulation and delivery technologies, including the use of lipid molecules, synthetic polymers called poloxamers, and other approaches, to enhance DNA expression or increase the immune response in DNA vaccine applications. We own broad rights to certain non-viral

 

3

 

polynucleotide delivery technologies through our series of core patents. Benefits of our DNA delivery technology may include the following which may enable us to offer novel treatment alternatives for diseases that are currently poorly addressed:

 

•                  Broad Applicability. Our DNA delivery technology may be useful in developing DNA vaccines for infectious diseases, in which the expressed protein induces an immune response; novel therapies for cancer, in which the expressed protein is an immune system stimulant or cancer-killing agent; and DNA therapeutic protein delivery, in which the expressed protein is a therapeutic agent;

 

•                  Convenience. Our DNA-based biopharmaceutical product candidates are intended to be administered on an outpatient basis;

 

•                  Safety. Our product candidates contain no viral components that may cause unwanted immune responses, infections, or malignant and permanent changes in the cell’s genetic makeup;

 

•                  Repeat Administration. Our product candidates contain no viral components that may preclude multiple dosing with a single product or use in multiple products;

 

•                  Ease of Manufacturing. Our product candidates are manufactured using straightforward fermentation and purification procedures; and

 

•                  Cost-Effectiveness. Our DNA delivery technology may be more cost-effective than other approaches. It may also cause fewer potential side effects, which itself may reduce per patient treatment costs.

 

Business Strategy

 

There are four basic elements to our business strategy:

 

Develop Products Independently

 

We currently focus our resources on the independent development of DNA vaccines for infectious diseases and cancer therapeutics. We intend to retain significant participation in the commercialization of our proprietary DNA vaccine and cancer products, although we may choose to enlist the support of marketing partners to accelerate market penetration.

 

Vaccines. Vaccines are perceived by government and medical communities as an efficient and cost-effective means of healthcare. According to the U.S. Centers for Disease Control and Prevention, or CDC, “Vaccines are among the very best protections we have against infectious diseases.” We believe our technology may lead to the development of novel preventive or therapeutic vaccines for infectious disease targets because:

 

•                  DNA vaccines may help combat diseases for which conventional vaccine methods have been unsuccessful;

 

•                  DNA vaccines may be safer than conventional vaccines; and

 

•                  DNA vaccines use straightforward manufacturing processes that may be simpler, more cost-efficient, and more generally applicable across a range of products than conventional vaccine production methods.

 

Cancer. In the cancer area, we have focused our resources on the development of Allovectin-7^® as a potential treatment for metastatic melanoma, an aggressive form of skin cancer, to best apply the expertise and relationships we have established through prior development and testing in this area. We have no other potential cancer products currently under independent preclinical or clinical development.

 

Enhance and Expand Our Technologies

 

We are actively pursuing the refinement of our plasmids and formulations, the evaluation of potential enhancements to our core technologies and the exploration of additional DNA delivery technologies. We are developing future product candidates based on these technologies through preclinical and clinical testing to determine their safety and effectiveness. We also seek to develop

 

4

 

additional applications for our technologies by testing new approaches to disease control or prevention. These efforts could lead to further independent product development or additional licensing opportunities. In addition, we continually evaluate compatible technologies or products that may be of potential interest for in-licensing or acquisition. We license intellectual property from companies holding complementary technologies in order to leverage the potential of our own DNA delivery technology and to further the discovery of innovative new therapies for internal development.

 

Expand the Applications of Our Technologies Through Strategic Collaborations

 

We collaborate with major pharmaceutical and biotechnology companies and government agencies, providing us access to complementary technologies or greater resources. These collaborations provide us with mutually beneficial opportunities to expand our product pipeline and serve significant unmet medical needs. We license our intellectual property to other companies in order to leverage our technologies for applications that may not be appropriate for our independent product development efforts.

 

Contract Manufacturing

 

In addition, we pursue contract manufacturing opportunities to leverage our infrastructure and expertise in plasmid manufacturing, and to provide revenues that contribute to our independent research and development efforts. We are currently engaged in contract manufacturing for the Dale and Betty Bumpers Vaccine Research Center, or VRC, of the National Institutes of Health, or NIH, and the International AIDS Vaccine Initiative, or IAVI.

 

Product Development

 

We are focused on the development of biopharmaceutical product candidates based on our patented DNA delivery technology. We, together with our licensees and collaborators, are currently developing a number of vaccine and therapeutic protein product candidates for the prevention or treatment of infectious diseases, cancer, and cardiovascular diseases. Our current independent development focus is on novel DNA vaccines for cytomegalovirus, or CMV, and anthrax, as well as our cancer immunotherapeutic, Allovectin-7^®. The table below summarizes our independent, out-licensed and collaborative product development programs.

 

5

 

Product Development Programs

 

Product Area		Project Target and Indication(s)		Development Status(1)		Development Rights
INFECTIOUS DISEASES
Infectious disease vaccines		Plasmodium falciparum (malaria)		Phase I/II		Vical
		Cytomegalovirus		Preclinical		Vical
		Bacillus anthracis (anthrax)		Preclinical		Vical
		HIV – preventive		Phase I		Merck
		HIV – therapeutic		Phase I		Merck
		Hepatitis B virus – preventive		Undisclosed		Merck
		Hepatitis B virus – therapeutic		Undisclosed		Merck
		Hepatitis C virus – preventive		Undisclosed		Merck
		Hepatitis C virus – therapeutic		Undisclosed		Merck
		Herpes simplex virus		Undisclosed		Merck
		Human papilloma virus – preventive		Undisclosed		Merck
		Human papilloma virus – therapeutic		Undisclosed		Merck
		Influenza virus		Undisclosed		Merck
		Mycobacterium tuberculosis		Undisclosed		Merck
CANCER
Immunotherapeutic vaccine		High-dose Allovectin-7® for metastatic melanoma		Phase II		Vical
Tumor-associated antigen		Undisclosed		Preclinical/Phase I		Centocor
therapeutic vaccines		Undisclosed		Undisclosed		Aventis Pasteur
CARDIOVASCULAR
Angiogenic growth factors		VEGF-2		Phase II		Corautus Genetics
		Undisclosed		Phase II		Aventis Pharmaceuticals
VETERINARY
Preventive vaccines		Various undisclosed		Research/Preclinical		Merial

 

(1)                                  “Research” indicates laboratory studies to evaluate a potential product candidate in a nonclinical setting. “Preclinical” indicates that a specific product candidate in a nonclinical setting has shown functional activity that is relevant to a targeted medical need, and is undergoing toxicology testing in preparation for filing an Investigational New Drug application.

 

Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Traditionally, clinical trials are done in three phases. Phase I clinical trials mark the first time a new drug or treatment is administered to humans and are normally conducted to determine the safety profile of a new drug. Phase II clinical trials are conducted in order to determine preliminary effectiveness, or efficacy, optimal dosage, and to confirm the safety profile. Phase III clinical trials are often large scale, multi-center studies conducted to compare a new treatment with a currently approved therapy. At times, a single trial may incorporate elements from different phases of development. An example might be a trial designed to determine both safety and initial efficacy. Such a trial may be referred to as a Phase I/II clinical trial.

 

6

 

DNA Vaccines for Infectious Diseases

 

DNA vaccines use portions of the genetic code of a pathogen to cause the host to produce specific features of the pathogen that may induce an immune response. This method potentially offers superior safety, ease and reliability of manufacturing, as well as convenient storage and handling characteristics, compared with conventional vaccines that use live, weakened, or dead pathogens to produce an immune response. DNA vaccines have the ability to induce potent T-cell responses against target pathogens as well as to trigger production of antibodies. Over the past decade, many scientific publications have documented the effectiveness of DNA vaccines in contributing to immune responses in dozens of species including fish, nonhuman primates and humans.

 

Vaccines are generally recognized as the most cost-effective approach for infectious disease healthcare. However, the technical limitations of conventional vaccine approaches have constrained the development of effective vaccines for many diseases. Development of vaccines based on conventional methods requires significant infrastructure in research and manufacturing. In addition, the safety risks associated with conventional vaccines may offset the potential benefits. We believe our potential vaccine products should be simpler to manufacture than vaccines made using chemical conjugation of polysaccharides and protein carriers or protein purification and refolding techniques involving mammalian or avian cell, or egg-based, culture procedures and live viruses. In addition, our DNA delivery technology may accelerate certain aspects of vaccine product development such as nonclinical evaluation and manufacturing, and has demonstrated a favorable safety profile.

 

In the broader vaccine marketplace, it is important to note a changing dynamic. Traditionally, vaccines have been predominantly focused on the pediatric market, intended to protect children from diseases that could cause them serious harm. Today, there is a growing interest in vaccines against diseases that may affect adolescents and adults, which include both sexually transmitted diseases and infections that strike opportunistically, such as during pregnancy or in immunocompromised individuals, including the geriatric population. We believe our technology, because of its safety and development timeline advantages, could be ideally suited for the development of this new generation of vaccines.

 

The selection of targets for our infectious disease programs is driven by three key criteria:  the complexity of the product development program, competition, and commercial opportunities.

 

Cytomegalovirus

 

In February 2003, we announced that a DNA-based immunotherapeutic vaccine against CMV will be our first independent development program focused on infectious diseases. Currently, there is no approved vaccine or even a late-stage vaccine development program for CMV. We intend to begin Phase I clinical testing of the vaccine by year-end 2003 for an initial indication in humans at high risk of serious complications from CMV infection—patients undergoing bone marrow or solid organ transplantation.

 

The Institute of Medicine, or IOM, of the National Academy of Sciences has estimated the cost of treating the consequences of CMV infection in the United States at more than $4 billion per year and placed a CMV vaccine in its first priority category on the basis of cost-effectiveness. Our initial focus on the transplantation indication should allow proof-of-concept that could then lead to the opportunity to develop a CMV vaccine for other high-risk groups such as immunocompromised individuals and women of reproductive age, and eventually, to a universal vaccine for pediatric use. The unmet medical need in pregnant women at-risk for CMV infection and the need for controlling viral transmission in the general population may allow product expansion in the years ahead.

 

Our CMV immunotherapeutic vaccine program is based on:

 

•                  CMV genes that encode highly immunogenic proteins associated with protective antibody and cellular immune responses,

 

•                  Our DNA vaccine technologies that have the ability to induce potent cellular immune responses and trigger production of antibodies without the safety concerns that conventional attenuated vaccines have posed for immunocompromised patients, and

 

7

 

•                  a focused clinical development plan designed to allow us to quickly establish proof of concept in transplant patients.

 

About CMV. CMV is a herpes virus, part of the family of viruses that cause genital herpes, cold sores or fever blisters, chicken pox and infectious mononucleosis. Although the body can never rid itself of CMV, a healthy immune system usually is able to keep the virus in check. As a result, CMV disease rarely occurs in healthy individuals, and reactivation typically occurs only when the immune system is compromised by other disease or drugs. People at greatest risk include bone marrow and solid organ transplant patients who take immunosuppressive drugs, AIDS patients and other immunocompromised individuals, and fetuses and newborns of mothers who become primarily infected during pregnancy.

 

CMV infection affects an estimated 30 to 60 percent of bone marrow transplant or organ transplant recipients, causing transplant rejection, serious illness and even death if untreated. Transplant patients who develop CMV disease use significantly more healthcare resources, including longer hospitalization, than asymptomatic or uninfected transplant patients. Expensive antiviral drug therapy is used to control the disease, but it does not prevent or eliminate the infection. As a result, many patients require long-term maintenance therapy, and reactivation of the disease often occurs if drug therapy is discontinued or if drug resistance develops. The treatment itself can be costly and, in some forms, inconvenient. Treatment is not effective for all patients and side effects may be severe, including damage to the bone marrow or kidneys.

 

The CDC estimates that, in the United States, CMV infects more than half of all adults by age 40, and as many as 85 percent of all adults at some point in their lives. An estimated 25,000 patients receive solid organ transplants in the United States annually, and another 4,000 receive bone marrow transplants, with similar numbers in the European market. Approximately one in a hundred infants in the United States is born with CMV infection, leading to severe consequences in about 3,600 infants and death in about 400 infants per year. Nearly 3,000 immunocompromised patients suffer from CMV infection in the United States each year, causing severe consequences in more than half of the cases and death in more than 150 cases.

 

Anthrax

 

In March 2003, we announced our second independent infectious disease DNA vaccine development program, an anthrax DNA vaccine which we intend to begin testing in humans by year-end 2003. We believe that we can develop a safe and effective DNA vaccine for anthrax that will validate the potential advantages of our proprietary vaccine technologies while addressing a pressing public need, because:

 

•                  The key anthrax immunogens have been identified, and we have verified in small animal studies that they can be delivered effectively by formulated DNA. Our technology allows us to readily combine two anthrax immunogens, Protective Antigen, or PA, and Lethal Factor, or LF, that together may provide broader protection than the currently licensed anthrax vaccine or proposed single recombinant protein vaccines;

 

•                  Our cationic lipid formulated DNA delivery technology, in which positively charged lipid molecules interact with the negatively charged DNA molecules, thus coating and protecting DNA, has established an excellent safety profile in previous clinical studies, and an important goal of this program is to extend that safety profile to vaccine applications;

 

•                  Another important goal of this program is to demonstrate that DNA vaccines can induce protective antibodies in humans and can do so with fewer injections than the currently licensed anthrax vaccine, offering a potentially shorter time to protection; and

 

•                  The potential stability of plasmid formulations may offer advantages in handling and storage, which would be important considerations for stockpiling.

 

Our anthrax vaccine team advanced this program from initial concept to evaluation of effectiveness in a stringent challenge model in less than ten months, and held a pre-IND meeting with the U.S. Food and Drug Administration, or FDA, in December 2002.

 

8

 

Results with multiple formulations of the vaccine in mouse and rabbit challenge models have been encouraging and we intend to begin a safety and immunogenicity study in human volunteers before year-end 2003.

 

We believe that the FDA would review this vaccine based on its Two-Animal Rule, which requires demonstration of effectiveness in two animal species in addition to safety in humans, and that development costs using this regulatory pathway should be moderate compared with conventional clinical trials.

 

Small Animal Testing. Our scientists developed formulated DNA vaccines encoding detoxified forms of two proteins produced by anthrax bacteria, PA and LF, that combine to form lethal toxin, or Letx, which contributes to the morbidity and mortality of anthrax. The vaccine formulations were tested in mice for their ability to produce anti-PA, anti-LF, and Letx-neutralizing antibodies.

 

In collaboration with The Ohio State University, or OSU, we then tested selected formulations in rabbits for immunogenicity. Groups of rabbits including vaccinated and control animals then were challenged by metered inhalation with aerosolized anthrax spores using established procedures and observed for lethal anthrax infection. Effectiveness data from this small animal testing were presented in March 2003 at the American Society for Microbiology meeting, “Future Directions for Biodefense Research:  Development of Countermeasures.”

 

Results from the rabbit study for cationic lipid formulated DNA vaccines indicated that:

 

•                  All PA DNA vaccine formulations stimulated anti-PA immune responses equal to or greater than the currently licensed anthrax vaccine;

 

•                  All rabbits immunized with PA DNA vaccine formulations, either alone or in combination with LF DNA vaccination, survived the inhalation challenge, indicating equivalent protection in rabbits to the currently licensed anthrax vaccine;

 

•                  All unvaccinated control rabbits died two to four days after challenge, validating the study procedures and confirming the severity of inhalation anthrax infection; and

 

•                  LF DNA vaccination stimulated anti-LF immune responses and, even when used alone, provided rabbits with partial protection against the inhalation challenge, suggesting a potential second means of protection and supporting its inclusion as a component of a bivalent anthrax vaccine candidate advancing into human testing.

 

This research has been supported, in part, by a one-year Small Business Technology Transfer Research, or STTR, grant from the U.S. National Institute of Allergy and Infectious Diseases, or NIAID, as announced in July 2002. In addition, we have submitted an application for a Phase II Small Business Innovation Research, or SBIR, grant to support, in part, the clinical development of our anthrax vaccine.

 

About Anthrax. Anthrax is a serious infectious disease most frequently occurring in hoofed mammals, but also affecting humans exposed to the spore-forming Bacillus anthracis. Bacterial spores can survive for extended periods and become active upon gaining access to a host. Human infection with anthrax spores can occur after exposure through a cut or abrasion on the skin or through ingestion of contaminated meat, but the most serious risk is through inhalation.

 

Inhalation anthrax results in death for 90 percent to 100 percent of those exposed, if not treated promptly. Symptoms typically appear within a week of exposure, and may be misdiagnosed as a common cold or flu. Bacterial spores travel from the lungs to the lymph nodes, where they begin to grow. Eventually, they spread into the circulatory system and throughout the body, causing widespread internal bleeding and organ failure. People who work with animals or process animal products are at greatest risk of naturally acquired infection. The greatest potential threat for most people is the inhalation of anthrax spores used in biological warfare or in a bioterrorist attack.

 

The toxic effects of anthrax infection are the result of three proteins produced by the bacteria:  PA, LF, and edema factor, or EF. PA couples with either EF or LF and allows these toxins to penetrate and kill host cells, releasing large numbers of bacteria into circulation.

 

9

 

In a review of the currently licensed anthrax vaccine, the IOM concluded, “the production, testing and licensure of a new vaccine requiring fewer doses and producing fewer local reactions is needed.” Treatment for proven or suspected anthrax infection involves a long course of antibiotic therapy beginning as soon as possible after diagnosis or suspected exposure. Antibiotics used against anthrax work by killing the bacteria to prevent further production of the toxic proteins. They do not eliminate proteins that accumulate before treatment, and do not offer residual protection against infection after the treatment course has been completed.

 

Other Infectious Diseases

 

To supplement our independent vaccine development programs, we have licensed our technology to Merck & Co., Inc., or Merck, for the development of vaccines against seven infectious disease targets including HIV, hepatitis B and C, herpes simplex, tuberculosis, human papilloma and influenza. We have collaborated with the U.S. Navy toward the development of a vaccine against malaria. We also have provided contract manufacturing and contract regulatory support for VRC and IAVI. Details on these and other relationships can be found in “Collaboration and Licensing Agreements—Corporate Collaborators—Out-licensing,” and “—Research Institutions,” and “—Biodefense Efforts.”

 

Cancer Therapies

 

Cancer is a disease of uncontrolled cell growth. When detected early and still confined to a single location, surgery or irradiation can often be curative. However, neither surgery nor irradiation is considered curative for cancer that has spread throughout the body. Chemotherapy can sometimes treat cancer that has spread throughout the body; however, a number of non-cancerous cells, such as bone marrow cells, are also highly susceptible to chemotherapy. As a result, chemotherapy often has fairly significant side effects. Finally, because each of these treatments only acts for a short period of time, it is common to see cancer return after apparently successful treatment.

 

Immunotherapy, using the patient’s own immune system, may have advantages over surgery, irradiation, and chemotherapy in the treatment of cancer. It is generally believed that the immune system can recognize cancer cells and destroy them. Yet many cancers appear to have developed the ability to “hide” from the immune system. A treatment that can augment the immune response against tumor cells by making the cancer more “visible” to the immune system would likely represent a significant improvement in cancer therapy. Immune-enhancing proteins such as interleukin-2, or IL-2, and interferon-alpha, or IFN-α, have shown encouraging results. However, these agents often require frequent doses that regularly result in severe side effects.

 

We have researched delivery enhancements that may complement our core DNA delivery technolog