Indeed, finding a cure for cancer has been a preoccupation of the medical research sector for several decades, and in recent years, significant progress has been made largely thanks to a number of approaches involving molecular engineering.

 

Recent advances have yet to deliver a cure for cancer. However, by zeroing in on tumours with specific antibodies, scientists are having success in at least arresting this deadly disease.  They hope to convert cancer from a terminal disease to a chronic disease.

 

Several companies are involved in the research and development of anti-cancer antibodies.  ProtoKinetix has strategically positioned itself in this exciting area by securing licenses and strategic alliances.

 

Moreover, ProtoKinetix is now making its own headline news in the field of oncology. This is illustrated by the April, 2004 announcement of encouraging preliminary results from the third-party validation trials on receptor alpha fetaprotein (RECAF) molecules. These trials are being conducted at the Georges Pompidou Hospital in France, which is one of the foremost medical institutions in Europe with one of the most advanced cancer research centres in the world.

 

Dr. Jean-Marie Dupuy, a ProtoKinetix advisor and a recent appointment to the board of directors, termed the results “very positive,” adding that the labelling of the malignant cells was strong and clear, with a distinct delineation between malignant and normal cells. That is a promising development at this early stage, but a closer look at ProtoKinetix and its chosen field will provide a clearer picture of the company’s potential.

 

ProtoKinetix started trading under its new name and symbol in August, 2003.  The company’s mission is to develop effective biological therapies for the treatment of malignancies. By utilising a select group of subcontractors with cutting edge technologies, ProtoKinetix will focus on the engineering of high potency, resilient antibodies resulting in vastly enhanced therapeutic impact.

 

A quick overview of the company’s field of expertise should provide investors with a good indication of the opportunities that it hopes to exploit.

 

Simply stated, an antibody is a protein that is created by one’s own body to fight a foreign substance and different antibodies are required to fight each unique germ or other invader. Monoclonal antibodies are mass-produced identical antibodies produced in a laboratory. A highly specific antibody will only attack its designated target.

 

It is because of that trait that monoclonal antibodies are playing an important role in the war against cancer. Conventional pharmaceutical cancer treatments such as chemotherapy are often highly toxic, attacking healthy cells and tissue, as well as the malignant tumours. As monoclonal antibodies target only the specific tumour cells that they were designed to attack, the treatment is relatively non-toxic and results in far fewer undesirable side effects.

 

As therapeutic drugs, monoclonal antibodies are already responsible for more product approvals and pending approvals in recent years than any other sector of the biotechnology industry. ProtoKinetix’ business strategy centres on the modification of monoclonal antibodies to improve their potency.  In turn, this improves their effectiveness in fighting foreign invaders such as cancer cells.

 

Based on early successes with its validation trials, a key part of ProtoKinetix’s scientific strategy will involve an attempt to create a “super-antibody” that will attach itself to RECAF molecules. Alpha fetaprotein is a carbohydrate molecule that is located on the surface of cancer cells. RECAF molecules with an attached “super-antibody” would theoretically attach themselves to the cancer cells, while causing little or no harm to non-cancerous cells.

 

The RECAF technology is patented by BioCurex Inc. ProtoKinetix has an exclusive, worldwide license to use the RECAF™ receptor in conjunction with the “super-antibody” technology and with the catalytic antibody platform.

 

Researchers have known about monoclonal antibodies for more than 25 years but much of the current interest in the field has gathered momentum within the past decade. This follows on the heels of the approval by the United States Food and Drug Administration of Rituxan as a “breakthrough blockbuster” cancer treatment in 1997. Since then, Idec and Genentech’s sales of Rituxan have grown exponentially, reaching US $818 million in 2001 and an extraordinary US $1.49 billion in 2003.

 

The Rituxan success story and the opportunities offered by further developments in monoclonal antibodies have resulted in some high valuations for a variety of biotechnology companies in recent years. It is therefore no surprise that there are now a large number of companies hopping aboard the monoclonal antibody bandwagon. This scenario makes ProtoKinetix’s business plan all the more compelling.

 

Late last year, ProtoKinetix signed an agreement with Perigene Inc., awarding that company a contract to conduct research into the development of a catalytic antibody against the RECAF receptor site. Peregrine acquired the rights to what is known as abzyme technology from the University of Compiegne in France. The work is scheduled to begin after the completion of encouraging validation trials being conducted at the George Pompidou Hospital.

 

The recent positive news from the trials appears to be an important milestone development. The validation trials are designed to confirm the existence of a receptor site that is unique to cancer cells that will bind to the molecule alpha fetaprotein. A member of ProtoKinetix’s scientific advisory board, Dr. Ricardo Moro, has demonstrated that the presence of alpha fetaprotein in the human body can be a non-specific indicator of the presence of cancer. Dr. Moro and ProtoKinetix believe that the RECAF receptor site exists as a specific receptor site for alpha fetaprotein and the positive early results of the validation trials appears to support that belief.

 

The development of monoclonal antibodies to the highly specific carbohydrate molecule attached to the RECAF protein will allow ProtoKinetix to engineer an antibody that should target and kill malignant cells. Based on the results of the validation trials, ProtoKinetix will generate antibodies to the RECAF receptor site and identify those that do not have a tendency to attack healthy cells. This work will be a key part of the arrangement with Perigene.

 

According to its business plan, ProtoKinetix is responsible for covering the costs of its various contracts and it will retain all of the product rights that flow from the deals, while granting incentive arrangements and royalties to its contractors. Each contract will involve the early-stage product development, which will then be advanced through contract research organizations that have expertise in clinical development.

 

On a corporate note, ProtoKinetix has an impressive array of medical expertise to draw from on its scientific advisory board and in its executive offices.

 

Dr. Todd, president of ProtoKinetix since last year, has invaluable experience in pharmaceutical drug development. A noteworthy entry on his resume is his participation in mammastatin research and the clinical development of mammastatin from natural sources. A graduate of the University of Calgary, Dr. Todd now practises as a surgeon in British Columbia.

 

Dr. Dupuy was added to the scientific advisory board of ProtoKinetix late last year, and he was appointed to the company’s board of directors in early April. He was instrumental in arranging the validation trials for the RECAF molecules. Dr. Dupuy is engaged as a consultant to several pharmaceutical and biotechnology companies, providing project development, scientific advice and clinical research, as well as clinical trial implementation and regulatory agency assistance.

 

Prior to his career in the pharmaceutical sector, Dr. Dupuy held several academic positions in both France and Canada. He was head of the Immunology and Virology Research Centre in France through most of the 1970s, and following that, he directed clinical immunology at the Montreal Children’s Hospital for eight years. As a director in charge of medical research for ProtoKinetix, Dr. Dupuy will be consulting with major European institutions regarding possible collaboration on a number of potential products.  

 

SmallCapMedia believes that ProtoKinetix is well on its way to establishing itself as a key innovator in an exciting new field in the treatment of cancer. Accordingly, the company is expected to galvanize a strong following among the investment community as speculators begin to understand the multi-billion dollar marketing implications of the development of anti-cancer “super-antibodies.”  

 

The scenario is already beginning to unfold. The company’s share price is beginning to establish a definitive upward trend, having doubled in value since the start of the year. The company benefits from a fairly tight share structure with approximately 30 million shares outstanding (of which about 15 million shares are currently restricted). Such a scenario, matched with positive news flow, typically acts as a catalyst to high share price valuations. SmallCapMedia therefore believes the advent of a continued flow of positive R&D news, as well as the signing of more licensing agreements, should continue to fuel ProtoKinetix’s upward trajectory throughout 2004 and beyond.