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