Interview with: Donald Segal, Ph.D., President and CEO - featuring: their two major drug candidates under development; Topical Interferon Alpha-2b, which we are developing as a preventative therapeutic against cervical cancer caused by human papilloma virus or HPV infection, and the second, L-DOS47 for lung cancer, is based on our DOS47 platform technology, which has multiple potential anti-cancer therapeutic applications. L-DOS47, is a precisely targeted therapeutic against the most prevalent form of lung cancer, adenocarcinoma.

Helix BioPharma Corp. (HBP-TSX) (Frankfurt WKN 918864)

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Focused On The Cancer Space, Helix BioPharma’s First Two Product Candidates Are A Topical Preventative Therapeutic Against Cervical Cancer And A Precisely Targeted Therapeutic Against The Leading Form Of Lung Cancer



Healthcare
Biotechnology
(HBP-TSX)
(Frankfurt WKN 918864)

Helix BioPharma Corp.

305 Industrial Parkway South Unit 3
Aurora ON L4G 6X7
Phone: 905-841-2300
www.helixbiopharma.com



Donald Segal, Ph.D.
President and CEO

Interview conducted by:
Walter Bank, Publisher
CEOCFOinterviews.com
Published – August 31, 2007

BIO:
Donald Segal, Ph.D.
Director, President, and CEO
Prior to joining the Helix BioPharma, Dr. Segal founded and managed two successful life science companies, which he subsequently sold. These companies manufactured human diagnostic test kits for both the domestic and international markets. Dr. Segal has served on the Biotechnology Panel for the Natural Sciences and Engineering Research Council of Canada as one of the representatives from the business sector involved in the research granting system.

Company Profile:
Helix BioPharma Corp. is a biopharmaceutical company focused on the development and commercialization of innovative cancer therapeutics. Helix seeks to commercialize the new products that result from its development efforts by establishing strategic licensing arrangements with market leaders in the appropriate therapeutic fields. 

Helix is actively researching a host of potential new anti-cancer drug-products based on its proprietary core technologies. The company is committed to investigating new directions in the field of cancer therapy by exploiting new technologies for and approaches to drug development and disease management.

Established by amalgamation in 1995, Helix is publicly listed, with its common shares traded on the Toronto Stock Exchange. In addition, the Corporation is quoted on the Frankfurt, Munich, Stuttgart and Berlin stock exchanges. Helix's trading symbol is "HBP.".

CEOCFO: Dr. Segal, tell us about Helix BioPharma and your business strategy.
Dr. Segal: “Helix BioPharma is a publicly traded biopharmaceutical company focused primarily on the development of innovative pharmaceuticals for the prevention and treatment of cancer. We are expanding our product pipeline through a combination of in-house drug discovery and mergers and acquisitions. 

Our business strategy is to develop products through mid-stage clinical trials and commercialize them mainly through royalty-bearing third-party partnerships, a strategy demonstrated with our first successfully launched product, Klean-Prep™.”

CEOCFO: Please tell our readers about you’re drug pipeline.
Dr. Segal: “At present, we have two major drug candidates under development. Our most advanced product candidate is Topical Interferon Alpha-2b, which we are developing as a preventative therapeutic against cervical cancer caused by human papilloma virus or HPV infection, as well as a number of other potential therapeutic indications. This product is in Phase 2 trials and we are getting ready to initiate pivotal studies both in the U.S. and abroad. The second, L-DOS47 for lung cancer, is based on our DOS47 platform technology, which has multiple potential anti-cancer therapeutic applications. L-DOS47, is a precisely targeted therapeutic against the most prevalent form of lung cancer, adenocarcinoma. We are advancing this product candidate toward human studies.”

CEOCFO: Tell us about your major accomplishments for 2007.
Dr. Segal: “2007 has been a year of significant progress for Helix. We successfully completed our first phase II clinical study with our Topical Interferon Alpha-2b product in women with potentially precancerous cervical lesions. Based on the positive results from this study, we are preparing for pivotal clinical trials in the U.S. and abroad. We also recently started another phase II clinical trial for the Interferon product for a second indication, ano-genital warts. We were also awarded our first U.S. patent for our emerging, broad-spectrum DOS47 technology, and significantly advanced our preclinical and manufacturing programs for our first DOS47-based product candidate, L-DOS47.” 

CEOCFO: What makes Helix unique?
Dr. Segal: “Our products and technologies are what make us unique. For example, through our patented DOS47 technology, we are pioneering a potentially revolutionary and broadly applicable new approach to the destruction of cancer cells. Our approach involves producing a modification of the microenvironmental state of the tumor, from the acidic state common to cancerous tissues to a more alkaline state similar to that generally exhibited by healthy tissues in the body. And, because the action is enzymatic in nature, it is thought to function in a highly repetitive or “amplified” fashion to achieve significant potency, thereby further differentiating it from conventional drug therapies. 

The way we achieve this effect is by delivering an enzyme drug called urease by intravenous injection to the site of tumors in the body, by virtue of a conjugated tumor-specific antibody. The antibody, in turn, is believed to anchor the urease to the external surfaces of the tumor cells, following which the urease enzyme is intended to catalyse a powerful, cancer cell killing extracellular reaction.”

CEOCFO: What is the school of thought behind your technology?
Dr. Segal: “There is a school of thought related to the alkalinity of the body. The main school of thought is that the body must maintain a relatively alkaline tissue structure in order to preserve good health. We are focusing on that concept but in a more targeted way. Most nutritionists think and talk in terms of alkalinity on a global basis; more of an effect on the entire body and achieving it with minerals and alkaline water sources etc., and that is very good for health. However, with respect to cancer, we have a novel, targeted approach. Precise targeting is important, as you cannot really eradicate tumors on a whole-body dietary alkalizing basis.

We are targeting tumors using a technology that is quite unique in the sense that it uses an enzyme that is designed to concentrate at a tumor site by virtue of a conjugated cancer-specific antibody. We are currently focused on a product candidate, L-DOS47, that specifically targets lung cancer adenocarcinomas.  

At the site of the tumor, among DOS47’s cascade of actions, we believe we are changing the tumor microenvironment in such a way that we are raising the local alkalinity, hopefully to a point where in fact we counteract cancer cell survival because cancer cells otherwise exist and propagate in an acidic environment.  Probably the single factor we found most interesting is that virtually all solid tumors surround themselves in an acid medium, which effectively neutralizes the body’s natural immune defenses against cancer. Left unchecked in an acidic environment, tumors grow and destroy normal tissues around them, replacing normal tissues with diseased tissues.

Our research also shows that L-DOS47 has chemotherapeutic potentiating or so called chemo-potentiating properties, and we intend to validate our findings in human clinical trials. The value we see from that standpoint is that L-DOS47, because of its microenvironmental alkalizing actions, may additionally function to enhance cancer cell uptake of conventional chemotherapeutic compounds, otherwise compromised by tumor acidity. As a result, we see great potential for L-DOS47 to act in synergy with conventional chemotherapeutic drugs.”

CEOCFO; What distinguishes your approach from other chemotherapy treatments for cancer?
Dr. Segal: “What distinguishes us from many other chemotherapy approaches is that we are not just trying to destroy the cancerous cells via a general cytotoxic action. Instead, we are inducing a fundamental change in the micro environment of the tumor. In addition to this, however, our therapy also induces a more conventional poisoning effect because it is designed to produce certain metabolites localized at the site of the lung cancer cells, which readily diffuse into and destroy the lung cancer cells.

Another aspect that distinguishes our approach is that our enzymatic action has the potential to function in a highly repetitive manner, thereby making it extremely powerful. We like to refer to this as an amplification factor. Simply, a DOS47 drug molecule does not just act once before being excreted by the body. Rather, it has the potential to act over and over upon the substrate molecule urea, which occurs in plentiful supply in the body, to produce its potent anti-cancer metabolites at the site of the tumor.

As well, conventional chemotherapies are not generally targeted specifically to certain tumor types. Rather, they indiscriminantly attack all rapidly dividing cells, cancerous and healthy, which is the main reason that conventional chemotherapy drugs often have severe, dose-limiting side-effects.”

CEOCFO: Please tell us more about your Interferon technology.
Dr. Segal: “Our Topical Interferon Alpha-2b is not a chemotherapeutic. Rather, it is an antiviral, anti-cancer compound. Presently, Interferon Alpha-2b is widely marketed as an injectable product for treatment of hepatitis C and various other conditions. It also has a proven history of effectiveness against certain HPV-induced lesions, although injectable administration is not considered favorable for this purpose. The novelty with our topical dosage form is that it permits Interferon Alpha-2b delivery across a wide skin or mucosal surface area to better target underlying viral infection than can be achieved through injectable administration.

Using our topical dosage form, we envision conducting clinical testing for a range of potential therapeutic indications. We are most advanced in trying to prevent cervical cancer by treating certain HPV-induced cervical lesions before they become cancerous. We believe our topical Interferon Alpha-2b dosage form is the first and only such product under development industry-wide.

Millions of women have HPV infections and are therefore at greater risk for cervical cancer. While there are now vaccines that can prevent some HPV infections from occurring in healthy women, many will not get the vaccine for a variety of reasons.  Accordingly, HPV infections will likely continue to represent a major medical problem for many years to come, for which there is no approved pharmaceutical treatment. We are working hard to change this.”

CEOCFO: Will your L-DOS47 technology be used as a standalone or as an adjunct therapy?
Dr. Segal: “With respect to efficacy, as I mentioned, our preliminary data indicate that L-DOS47 is a chemo-potentiator, meaning that it has the ability to enhance the potency of chemotherapeutic agents, thereby enabling greater efficacy at lower doses.  

Chemotherapeutic agents attack rapidly dividing cancer cells as well as other rapidly dividing cells that are not cancerous. Because of this, chemotherapeutic agents tend to cause significant, often debilitating side effects; so many patients refuse to take them or can only tolerate sub-optimal doses.

With our L-DOS47 product candidate, we believe that we induce an alkalizing effect locally at the tumor site, in turn allowing enhanced cancer cell uptake of certain conventional chemotherapeutic compounds. We believe that by enabling this, it will be possible to give significantly lower doses of chemotherapeutic drugs, perhaps as little as 20% of the standard dose, and still produce the same cell-killing effect on the cancerous tissue. That would be a big step forward in terms of side-effect reduction and would give patients more hope while improving patient compliance.

To accelerate our DOS47 pipeline, we are seeking to establish partnerships and alliances with major pharmaceutical companies who are leaders in cancer chemotherapy with interests in developing potent adjunct therapeutic regimens combining our DOS47 technology and their compounds.”

CEOCFO: How do you maintain the competitive edge?
Dr. Segal: “Our goal is to bring truly unique and exceptional drug products to market, which will thereby distinguish Helix as a leader among its peers and competitors. With each of our two drug development initiatives presently underway, we have products designed to address major unmet medical and market needs. We believe that we represent innovators and leaders in the development of treatments for precancerous cervical lesions and lung adenocarcinomas.”

CEOCFO; Tell us about your senior management team and their strengths.
Dr. Segal: “We have a very strong senior management team with a combined 125 years of related industry experience. Together, this team manages approximately 30 staff across our three principal facilities, in addition to a network of highly respected third-party contract service providers.” 

CEOCFO: How are you planning to grow and do you have the capital or credit to accomplish this?
Dr. Segal: “Our growth strategy involves striving to continually expand our product development pipeline, while endeavoring to also develop significant “big pharma” commercial partnerships for our maturing drug candidates. 

We are always looking for new drug candidates to add to our product pipeline, both through our in-house R&D efforts and through prospective M&A events. Furthermore, we believe that our present drug development initiatives are nearing stages that will give them significant “big pharma” partnering potential within the foreseeable future. Achieving such partnerships for biopharmaceutical companies usually causes the markets to respond positively, so that a company’s valuation and positioning can strengthen in order to continue the cycle of attracting new, value-creating business opportunities.

With respect to our capital resources, we are actively seeking financing to execute our business plan for the next 24 months. We believe we are well positioned to attract continued funding in the coming months, given our noteworthy products and technologies, our seasoned team of professionals and our attractive valuation at this stage in our development.”

CEOCFO: How is the company positioned in the market place?
Dr. Segal: “As I mentioned, we are developing products that address significant, unmet medical needs in cancer. In the case of our Topical Interferon Alpha-2b, more than 1.4 million American women are diagnosed with potentially precancerous cervical lesions each year. At present, there are no approved pharmaceutical therapies available. The only available treatments are surgical in nature, and carry significant side-effect potential, causing them to be restricted to only the more advanced, so-called persistent patients. This leaves many women having to live with fear and anxiety, left to hope that their lesions will resolve spontaneously. 

Based on our clinical findings to date, we believe that we are well on our way to having a product with the potential to offer millions of women a simple, self-medicated, safe and effective means to resolve their lesions. We expect that this will have tremendous benefits, not only medically but also from a “peace-of-mind” perspective for those women who would otherwise not be candidates for therapy today.

In the case of our L-DOS47 initiative, there simply are no effective treatments available today for lung adenocarcinomas; the most prominent and deadly form of lung cancer affecting over 90,000 Americans a year. We believe we are developing a potential breakthrough approach to target and destroy lung cancer cells, as I’ve described, which will differentiate us significantly from our peers and competitors.”

CEOCFO: In closing, why should a potential investor look at your company?
Dr. Segal: “Helix is at a significant inflection point in its evolution, which we believe makes the company attractive for investment. 

After much hard work and dedication at the preclinical and proof-of-concept stages, our products are poised to significantly advance through clinical development over the next few years. 

As we move forward, I believe that there is excellent potential for the Company’s valuation and programs to advance considerably for all the reasons I’ve stated, and I look forward to the work that lies ahead to make this happen.”

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“Our goal is to bring truly unique and exceptional drug products to market, which will thereby distinguish Helix as a leader among its peers and competitors. With each of our two drug development initiatives presently underway, we have products designed to address major unmet medical and market needs. We believe that we represent innovators and leaders in the development of treatments for precancerous cervical lesions and lung adenocarcinomas.” - Donald Segal, Ph.D.