| Comediennes such as Gilda Radner and Madeline | | | | time to relapse of about 10.4 months. Patients who |
| Kahn, Oscar-winning actresses like Loretta Young and | | | | have turned to OvaRex hope to delay that relapse. |
| Sandy Dennis, singers Laura Nyro and Dinah Shore, | | | | Tyrrell noted, "In the original study, the average time |
| actor Pierce Brosnan's wife Cassandra Harris, actress | | | | to relapse was delayed by about 14 months. If we |
| Jessica Tandy, former Connecticut governor Ella | | | | can achieve that difference or better in the current |
| Grasso, and Martin Luther King's wife Coretta Scott | | | | Phase III trials, it would be a major advance for the |
| King all died of ovarian cancer. It's not just celebrities, | | | | treatment of ovarian cancer." He expects an analysis |
| politicians or movie stars, who are stricken with | | | | of the current OvaRex® MAb studies to be |
| ovarian cancer. One in every 55 U.S. women is at risk | | | | completed by the second or third quarter of 2007. |
| for ovarian cancer. The American Cancer Society | | | | What makes OvaRex® MAb different from |
| estimates about 22,000 new cases of ovarian cancer | | | | other immunotherapeutic treatments is, instead of |
| will be diagnosed. More than 16,000 women will die | | | | attacking the body's cancerous cells directly, the |
| because the symptoms are often subtle, and her | | | | monoclonal antibody targets the cancerous antigen in |
| doctor did not recognize the symptoms soon enough. | | | | circulation. Some believe it helps retrain the body's |
| It is the leading cause of death from gynecologic | | | | immune system to fight the ovarian cancer cells. The |
| malignancies, and the fifth leading cause of cancer | | | | mechanism that reportedly has made OvaRex® |
| deaths among women. | | | | MAb effective is how it alerts the body to recognize |
| Silent and undetected, this cancer often spreads | | | | and fight the CA-125. |
| beyond the ovary or ovaries into the abdominal | | | | ViRexx has addressed the "tolerance problem" a |
| cavity, or by the final stage, into other body organs | | | | body suffers when it has become inflicted with a |
| such as the liver or lungs. Family doctors often fail to | | | | malignant tumor. The hypothesis behind the tolerance |
| properly diagnose "The Silent Killer" until it is too late. | | | | issue is that the body fails to recognize the CA-125 |
| Last August, University of California Davis | | | | antigen as harmful. Introducing a foreign antibody, in |
| researchers reported 40 percent of women told their | | | | this case the mouse antibody against CA125, the |
| doctors about their symptoms for as long as a year | | | | body's defense systems are awakened to the |
| before they were correctly diagnosed. A British | | | | ovarian cancer cells. This begins a chain reaction |
| survey discovered 75 percent of family doctors | | | | alerting the immune system to battle the invading |
| believed symptoms are only present during the | | | | antibody CA125 complex. The body's defense |
| advanced stages of the cancer. By the time women | | | | systems are reprogrammed to attack the CA-125 |
| are diagnosed for ovarian cancer, 40 to 50 percent | | | | antigen and seek to destroy it. Along with that |
| of the patients are in the advanced stage, where | | | | destruction comes the attempt of the immune |
| there is little hope for survival. | | | | response to eliminate the cancerous cells from the |
| Less than one-half the women diagnosed with | | | | body. |
| ovarian cancer will live five years. About 10 to 14 | | | | As with many pioneering scientific breakthroughs, |
| percent live beyond five years after their diagnosis. | | | | serendipity is what lies behind the OvaRex® MAb |
| Their choices have been limited, mainly reserved to | | | | story. As one technology was being developed, |
| variations of chemotherapy drugs or a new way to | | | | another - the murine monoclonal antibody treatment |
| delivery the drug. The general public is often unaware | | | | for ovarian cancer - came about by accident. We |
| of the side effects ovarian cancer patients suffer | | | | talked to its inventor, Dr. Antoine Noujaim, about the |
| during chemotherapy. In mid March, the U.S. Food and | | | | biotech drug's roots. "It came out of the imaging |
| Drug Administration criticized the safety profile of Eli | | | | technology," the Professor Emeritus of the University |
| Lilly's Gemzar for ovarian cancer patients, saying the | | | | of Alberta explained. In the early 1980s, biotech |
| 2.8 months increased survival seen in studies of | | | | companies, such as Immunomedics and Cytomedics |
| patients taking the drug wasn't enough to offset the | | | | were researching tumors and using antibodies to |
| treatment's increased toxicity which included anemia, | | | | image the tumors so they could be evaluated in a |
| neutropenia (a blood disorder) and thrombocytopenia | | | | cancer patient's body. "I worked with Dr. Mike |
| (reduced platelets in the blood). | | | | Longenecker and we established a company called |
| Presently used first-line treatments for ovarian cancer | | | | Biomira (Toronto: BRA) in 1984," Dr. Noujaim recalled. |
| patients include Cisplatin, with associated side effects | | | | "We had a number of targets and then needed to |
| such as nerve, kidney and/or ear damage, Carboplatin | | | | make specific antibodies." Part of his effort was to |
| (side effects: nerve damage in the arms and/or legs, | | | | target certain cancers, such as prostate, breast and |
| joint pain, and/or thrombocytopenia), Paclitaxel | | | | ovarian cancer. |
| (neurotoxicity), or Melphalan, with side effects which | | | | "We developed antibodies against a mucin, which is |
| include irreversible bone marrow failure, bone marrow | | | | really a glycopeptide," explained Dr. Noujaim. "It's a |
| suppression). | | | | peptide that has a lot of sugars on it present in the |
| A woman stricken with ovarian cancer faces first | | | | ascitis fluid from ovarian cancer patients." That is how |
| surgery, then chemotherapy. Recent widespread | | | | Dr. Noujaim and his team developed the very early |
| press heralding a new development in treating ovarian | | | | antibody which is now used for OvaRex® MAb. |
| cancer, intra-abdominal or intraperitoneal | | | | "We sent some of these antibodies to Professor |
| chemotherapy, is just that: more chemotherapy. The | | | | Richard Baum in Germany for imaging of ovarian |
| "belly bath," as it has been nicknamed by some | | | | cancer patients," Noujaim remembered. "Dr. Baum |
| television reporters, it has been highly praised | | | | phoned back, after some time, and told me, 'The |
| because the treatment can extend life by about 16 | | | | patients I was imaging here had advanced ovarian |
| months more than "regular" chemotherapy. The | | | | cancer and some of them seem to have done quite |
| results were first published in the prestigious New | | | | well after we gave them a couple of shots (of the |
| England Journal of Medicine in December 2005. Most | | | | B43.13 antibody, the clinical name for OvaRex® |
| news reports failed to mention that only 40 percent | | | | MAb) to image the tumor.' I thought he was joking |
| of the women treated with the belly bath were able | | | | with me." |
| to complete all six cycles. Why? The therapy relies | | | | This is serendipity at work as Dr. Noujaim explained |
| upon infusions of Paclitaxel and Cisplatin (see side | | | | to us. "Richard was imaging patients that were in the |
| effects in the previous paragraph). According to Dr. | | | | last stages of the disease," he pointed out. |
| Robert Edwards, research director of the | | | | Monoclonal antibodies can be used as diagnostic |
| Magee-Women's Gynecologic Cancer in Pittsburgh, | | | | agents in oncology, when they are radiolabeled with a |
| "Many women don't feel well enough to work for the | | | | marker that can be imaged by external detectors. |
| duration of the intra-abdominal (therapy)." Some | | | | "These patients had maybe four or five months to |
| patients, such as Cindy Pakalnis of Marshall | | | | live. All of a sudden, a year later and they're still |
| (Pennsylvania) have called the treatments "grueling." | | | | around." Baum urged Noujaim to investigate this |
| The unsolved problem of chemotherapy is the | | | | further. Dr. Noujaim recalls him saying, "Something is |
| reduction in the "quality of life." While some life | | | | happening here. I've seen hundreds of patients, but |
| extension has been proven, the patient's life | | | | nothing like this." From this encouragement, Noujaim |
| deteriorates. Many patients struggle with balancing | | | | began formulating the potential mechanism of how |
| the loss in quality of life with the rigors of the | | | | this monoclonal antibody would work. His sharp mind |
| therapy. Researchers are actively pursuing new | | | | chased the puzzling questions raised by Dr. Baum's |
| directions that may some day provide new hope for | | | | observations. |
| the ovarian cancer patient. A University of Minnesota | | | | At this point of his recollections, Noujaim got excited, |
| research study has suggested the use of thalidomide, | | | | "Through sheer serendipity, we were using murine |
| which would be used in conjunction with | | | | antibodies, not humanized antibodies. We were using |
| chemotherapy, as a prospective means of increasing | | | | foreign antibodies, a small amount of foreign |
| the likelihood of remission. Minnesota cancer | | | | antibodies." How in the world did Noujaim know to |
| researcher Dr. Levi Downs explained, "It prevents the | | | | use murine (mouse) antibodies? "Because that was |
| tumor from making new blood vessels. Without new | | | | the easiest way to do the imaging at the time," he |
| blood vessels, the tumor can't sufficiently feed new | | | | replied. "Before you make a chimeric (something |
| cells, so the cancer can't grow." His randomized trial | | | | derived from two different animal species) antibody, |
| was small with only 65 patients (only 28 took | | | | you start with a murine one. If that one works, you |
| thalidomide), and more testing will certainly be | | | | humanize the antibody." From this research, Noujaim |
| required. | | | | founded a company called AltaRex, which was taken |
| New Hope for Ovarian Cancer Patients? | | | | public in 1995. "We raised about $30 million and |
| One promising technology that has been developed | | | | expanded the program." |
| over the past decade is OvaRex® MAb. It was | | | | The serious effort to develop the antibodies began in |
| developed by ViRexx Medical Corp., an | | | | 1996. Having conducted trials in Canada and Europe, it |
| Edmonton-based company, which trades on the | | | | was a "massive undertaking" Noujaim told us. "We |
| American Stock Exchange (ticker symbol: REX) and | | | | had over 500 patients injected with the murine |
| on the Toronto Stock Exchange (ticker symbol: VIR). | | | | monoclonal antibody." He extrapolated beyond |
| Now licensed to Unither Pharmaceuticals, a wholly | | | | OvaRex® MAb, saying, "We've proven |
| owned subsidiary of United Therapeutics (NASDAQ: | | | | completely the mechanism of action on this, how it |
| UTHR), OvaRex® MAb is currently undergoing | | | | works. It is so unique it may apply to all of the other |
| two identical Phase III trials at about 64 research | | | | antibodies we have." Noujaim believes it can apply to |
| centers across the United States. One trial has | | | | breast, ovarian, prostate and pancreatic cancer. |
| completed enrollment, according to a mid December | | | | Indeed, BrevaRex® MAb for breast cancer and |
| news release issued by ViRexx Medical Corp. | | | | multiple myeloma patients has completed Phase 1 |
| We spoke with ViRexx Medical Corp's Chief | | | | trials, and ProstaRex® MAb for prostate cancer |
| Executive Officer, Dr. Tyrrell who was the Dean of | | | | patients is at the pre-clinical stage. |
| the Faculty of Medicine and Dentistry at the | | | | "Our studies to date may show that vaccines may |
| University of Alberta and the Director of the Glaxo | | | | slow the growth of the tumor with a very good |
| Heritage Research Institute. "OvaRex® MAb is | | | | safety profile," concluded Dr. Noujaim. Then he added |
| our lead candidate for the treatment of ovarian | | | | something which bears investigating further, "There is |
| cancer, and is an intravenous infusion of a monoclonal | | | | the very original (ovarian cancer) patient who was |
| antibody," he said. Monoclonal antibodies are a new | | | | injected in 1987. She's in Germany, and according to |
| breed of biotech drugs that are extremely specific; | | | | Dr. Baum she was still alive a year ago." That's nearly |
| that is, each antibody binds to only one particular | | | | nine years later! "It's a matter of great pride for me |
| antigen. In the case of OvaRex® MAb, it is a | | | | that some people who received OvaRex® MAb |
| monoclonal antibody that binds specifically to the | | | | are alive today," he said. |
| CA-125 antigen. Dr. Tyrrell added, "The treatment | | | | While the company has licensed, under a royalty |
| doesn't take long, and is given every 4 weeks for | | | | agreement, the OvaRex® MAb technology to |
| the first 3 injections, and then once every 3 months | | | | United Therapeutics, through that company's |
| until the patient relapses". | | | | subsidiary, Unither Pharmaceuticals, ViRexx has |
| Dr. Tyrrell talked about the current Phase III studies, | | | | retained rights to most member nations of the |
| "The trials are ongoing. All of the patients have | | | | European Union and certain other countries. Key ones |
| successfully completed their surgery and front-line | | | | include France, the United Kingdom and the Benelux |
| chemotherapy and are now in what we call the | | | | countries. ViRexx has also established strategic |
| 'watchful waiting' period. It is in this phase that we | | | | relationships with Dompé Farmaceutici, |
| treat the patients with OvaRex® MAb with the | | | | Medison Pharma, Ltd. and Genesis Pharma S.A. for |
| hopes of increasing the time to disease relapse." He | | | | certain European and Middle-East Countries. |
| explained the recurrence rate is very high in the | | | | COPYRIGHT © 2007 by StockInterview, Inc. |
| stage III / IV late forms of ovarian cancer, with a | | | | ALL RIGHTS RESERVED. |