Stimulating The Bodys Defenses To Fight Ovarian Cancer

Stimulating The Bodys Defenses To Fight Ovarian Cancer

Stimulating the​ Body’s Defenses to​ Fight Ovarian Cancer
Comediennes such as​ Gilda Radner and​ Madeline Kahn, Oscar-winning actresses like Loretta Young and​ Sandy Dennis, singers Laura Nyro and​ Dinah Shore, actor Pierce Brosnan’s wife Cassandra Harris, actress Jessica Tandy, former Connecticut governor Ella Grasso, and​ Martin Luther King’s wife Coretta Scott King all died of​ ovarian cancer .​
It’s not just celebrities, politicians or​ movie stars, who are stricken with ovarian cancer .​
One in​ every 55 U.S .​
women is​ at​ risk for​ ovarian cancer .​
The American Cancer Society estimates about 22,000 new cases of​ ovarian cancer will be diagnosed .​
More than 16,000 women will die because the​ symptoms are often subtle, and​ her doctor did not recognize the​ symptoms soon enough .​
It is​ the​ leading cause of​ death from gynecologic malignancies, and​ the​ fifth leading cause of​ cancer deaths among women.

Silent and​ undetected, this cancer often spreads beyond the​ ovary or​ ovaries into the​ abdominal cavity, or​ by the​ final stage, into other body organs such as​ the​ liver or​ lungs .​
Family doctors often fail to​ properly diagnose the​ Silent Killer until it​ is​ too late .​
Last August, University of​ California Davis researchers reported 40 percent of​ women told their doctors about their symptoms for​ as​ long as​ a​ year before they were correctly diagnosed .​
a​ British survey discovered 75 percent of​ family doctors believed symptoms are only present during the​ advanced stages of​ the​ cancer .​
By the​ time women are diagnosed for​ ovarian cancer, 40 to​ 50 percent of​ the​ patients are in​ the​ advanced stage, where there is​ little hope for​ survival.
Less than one-half the​ women diagnosed with ovarian cancer will live five years .​
About 10 to​ 14 percent live beyond five years after their diagnosis .​
Their choices have been limited, mainly reserved to​ variations of​ chemotherapy drugs or​ a​ new way to​ delivery the​ drug .​
The general public is​ often unaware of​ the​ side effects ovarian cancer patients suffer during chemotherapy .​
In mid March, the​ U.S .​
Food and​ Drug Administration criticized the​ safety profile of​ Eli Lilly’s Gemzar for​ ovarian cancer patients, saying the​ 2.8 months increased survival seen in​ studies of​ patients taking the​ drug wasn’t enough to​ offset the​ treatment’s increased toxicity which included anemia, neutropenia (a blood disorder) and​ thrombocytopenia (reduced platelets in​ the​ blood) .​
Presently used first-line treatments for​ ovarian cancer patients include Cisplatin, with associated side effects such as​ nerve, kidney and/or ear damage, Carboplatin (side effects: nerve damage in​ the​ arms and/or legs, joint pain, and/or thrombocytopenia), Paclitaxel (neurotoxicity), or​ Melphalan, with side effects which include irreversible bone marrow failure, bone marrow suppression).

A woman stricken with ovarian cancer faces first surgery, then chemotherapy .​
Recent widespread press heralding a​ new development in​ treating ovarian cancer, intra-abdominal or​ intraperitoneal chemotherapy, is​ just that: more chemotherapy .​
The belly bath, as​ it​ has been nicknamed by some television reporters, it​ has been highly praised because the​ treatment can extend life by about 16 months more than regular chemotherapy .​
The results were first published in​ the​ prestigious New England Journal of​ Medicine in​ December 2018 .​
Most news reports failed to​ mention that only 40 percent of​ the​ women treated with the​ belly bath were able to​ complete all six cycles .​
Why? the​ therapy relies upon infusions of​ Paclitaxel and​ Cisplatin (see side effects in​ the​ previous paragraph) .​
According to​ Dr .​
Robert Edwards, research director of​ the​ Magee-Women’s Gynecologic Cancer in​ Pittsburgh, Many women don’t feel well enough to​ work for​ the​ duration of​ the​ intra-abdominal (therapy) .​
Some patients, such as​ Cindy Pakalnis of​ Marshall (Pennsylvania) have called the​ treatments grueling.
The unsolved problem of​ chemotherapy is​ the​ reduction in​ the​ quality of​ life .​
While some life extension has been proven, the​ patient’s life deteriorates .​
Many patients struggle with balancing the​ loss in​ quality of​ life with the​ rigors of​ the​ therapy .​
Researchers are actively pursuing new directions that may some day provide new hope for​ the​ ovarian cancer patient .​
a​ University of​ Minnesota research study has suggested the​ use of​ thalidomide, which would be used in​ conjunction with chemotherapy, as​ a​ prospective means of​ increasing the​ likelihood of​ remission .​
Minnesota cancer researcher Dr .​
Levi Downs explained, It prevents the​ tumor from making new blood vessels .​
Without new blood vessels, the​ tumor can’t sufficiently feed new cells, so the​ cancer can’t grow .​
His randomized trial was small with only 65 patients (only 28 took thalidomide), and​ more testing will certainly be required.
New Hope for​ Ovarian Cancer Patients?
One promising technology that has been developed over the​ past decade is​ OvaRex® MAb .​
It was developed by ViRexx Medical Corp., an​ Edmonton-based company, which trades on the​ American Stock Exchange (ticker symbol: REX) and​ on the​ Toronto Stock Exchange (ticker symbol: VIR) .​
Now licensed to​ Unither Pharmaceuticals, a​ wholly owned subsidiary of​ United Therapeutics (NASDAQ: UTHR), OvaRex® MAb is​ currently undergoing two identical Phase III trials at​ about 64 research centers across the​ United States .​
One trial has completed enrollment, according to​ a​ mid December news release issued by ViRexx Medical Corp.
We spoke with ViRexx Medical Corp’s Chief Executive Officer, Dr .​
Tyrrell who was the​ Dean of​ the​ Faculty of​ Medicine and​ Dentistry at​ the​ University of​ Alberta and​ the​ Director of​ the​ Glaxo Heritage Research Institute .​
OvaRex® MAb is​ our lead candidate for​ the​ treatment of​ ovarian cancer, and​ is​ an​ intravenous infusion of​ a​ monoclonal antibody, he said .​
Monoclonal antibodies are a​ new breed of​ biotech drugs that are extremely specific; that is, each antibody binds to​ only one particular antigen .​
In the​ case of​ OvaRex® MAb, it​ is​ a​ monoclonal antibody that binds specifically to​ the​ CA-125 antigen .​
Dr .​
Tyrrell added, the​ treatment doesn’t take long, and​ is​ given every 4 weeks for​ the​ first 3 injections, and​ then once every 3 months until the​ patient relapses.

Dr .​
Tyrrell talked about the​ current Phase III studies, the​ trials are ongoing .​
All of​ the​ patients have successfully completed their surgery and​ front-line chemotherapy and​ are now in​ what we call the​ ‘watchful waiting’ period .​
It is​ in​ this phase that we treat the​ patients with OvaRex® MAb with the​ hopes of​ increasing the​ time to​ disease relapse .​
He explained the​ recurrence rate is​ very high in​ the​ stage III / IV late forms of​ ovarian cancer, with a​ time to​ relapse of​ about 10.4 months .​
Patients who have turned to​ OvaRex hope to​ delay that relapse .​
Tyrrell noted, In the​ original study, the​ average time to​ relapse was delayed by about 14 months .​
If we can achieve that difference or​ better in​ the​ current Phase III trials, it​ would be a​ major advance for​ the​ treatment of​ ovarian cancer .​
He expects an​ analysis of​ the​ current OvaRex® MAb studies to​ be completed by the​ second or​ third quarter of​ 2018.
What makes OvaRex® MAb different from other immunotherapeutic treatments is, instead of​ attacking the​ body’s cancerous cells directly, the​ monoclonal antibody targets the​ cancerous antigen in​ circulation .​
Some believe it​ helps retrain the​ body’s immune system to​ fight the​ ovarian cancer cells .​
The mechanism that reportedly has made OvaRex® MAb effective is​ how it​ alerts the​ body to​ recognize and​ fight the​ CA-125 .​

ViRexx has addressed the​ tolerance problem a​ body suffers when it​ has become inflicted with a​ malignant tumor .​
The hypothesis behind the​ tolerance issue is​ that the​ body fails to​ recognize the​ CA-125 antigen as​ harmful .​
Introducing a​ foreign antibody, in​ this case the​ mouse antibody against CA125, the​ body’s defense systems are awakened to​ the​ ovarian cancer cells .​
This begins a​ chain reaction alerting the​ immune system to​ battle the​ invading antibody CA125 complex .​
The body’s defense systems are reprogrammed to​ attack the​ CA-125 antigen and​ seek to​ destroy it .​
Along with that destruction comes the​ attempt of​ the​ immune response to​ eliminate the​ cancerous cells from the​ body.
As with many pioneering scientific breakthroughs, serendipity is​ what lies behind the​ OvaRex® MAb story .​
As one technology was being developed, another – the​ murine monoclonal antibody treatment for​ ovarian cancer – came about by accident .​
We talked to​ its inventor, Dr .​
Antoine Noujaim, about the​ biotech drug’s roots .​
It came out of​ the​ imaging technology, the​ Professor Emeritus of​ the​ University of​ Alberta explained .​
In the​ early 1980s, biotech companies, such as​ Immunomedics and​ Cytomedics were researching tumors and​ using antibodies to​ image the​ tumors so they could be evaluated in​ a​ cancer patient’s body .​
I​ worked with Dr .​
Mike Longenecker and​ we established a​ company called Biomira (Toronto: BRA) in​ 1984, Dr .​
Noujaim recalled .​
We had a​ number of​ targets and​ then needed to​ make specific antibodies .​
Part of​ his effort was to​ target certain cancers, such as​ prostate, breast and​ ovarian cancer.

We developed antibodies against a​ mucin, which is​ really a​ glycopeptide, explained Dr .​
Noujaim .​
It’s a​ peptide that has a​ lot of​ sugars on it​ present in​ the​ ascitis fluid from ovarian cancer patients .​
That is​ how Dr .​
Noujaim and​ his team developed the​ very early antibody which is​ now used for​ OvaRex® MAb .​
We sent some of​ these antibodies to​ Professor Richard Baum in​ Germany for​ imaging of​ ovarian cancer patients, Noujaim remembered .​
Dr .​
Baum phoned back, after some time, and​ told me, ‘The patients I​ was imaging here had advanced ovarian cancer and​ some of​ them seem to​ have done quite well after we gave them a​ couple of​ shots (of the​ B43.13 antibody, the​ clinical name for​ OvaRex® MAb) to​ image the​ tumor.’ I​ thought he was joking with me.

This is​ serendipity at​ work as​ Dr .​
Noujaim explained to​ us .​
Richard was imaging patients that were in​ the​ last stages of​ the​ disease, he pointed out .​
Monoclonal antibodies can be used as​ diagnostic agents in​ oncology, when they are radiolabeled with a​ marker that can be imaged by external detectors .​
These patients had maybe four or​ five months to​ live .​
All of​ a​ sudden, a​ year later and​ they’re still around .​
Baum urged Noujaim to​ investigate this further .​
Dr .​
Noujaim recalls him saying, Something is​ happening here .​
I’ve seen hundreds of​ patients, but nothing like this .​
From this encouragement, Noujaim began formulating the​ potential mechanism of​ how this monoclonal antibody would work .​
His sharp mind chased the​ puzzling questions raised by Dr .​
Baum’s observations.
At this point of​ his recollections, Noujaim got excited, Through sheer serendipity, we were using murine antibodies, not humanized antibodies .​
We were using foreign antibodies, a​ small amount of​ foreign antibodies .​
How in​ the​ world did Noujaim know to​ use murine (mouse) antibodies? Because that was the​ easiest way to​ do the​ imaging at​ the​ time, he replied .​
Before you make a​ chimeric (something derived from two different animal species) antibody, you start with a​ murine one .​
If that one works, you humanize the​ antibody .​
From this research, Noujaim founded a​ company called AltaRex, which was taken public in​ 1995 .​
We raised about $30 million and​ expanded the​ program.

The serious effort to​ develop the​ antibodies began in​ 1996 .​
Having conducted trials in​ Canada and​ Europe, it​ was a​ massive undertaking Noujaim told us .​
We had over 500 patients injected with the​ murine monoclonal antibody .​
He extrapolated beyond OvaRex® MAb, saying, We’ve proven completely the​ mechanism of​ action on this, how it​ works .​
It is​ so unique it​ may apply to​ all of​ the​ other antibodies we have .​
Noujaim believes it​ can apply to​ breast, ovarian, prostate and​ pancreatic cancer .​
Indeed, BrevaRex® MAb for​ breast cancer and​ multiple myeloma patients has completed Phase 1 trials, and​ ProstaRex® MAb for​ prostate cancer patients is​ at​ the​ pre-clinical stage.

Our studies to​ date may show that vaccines may slow the​ growth of​ the​ tumor with a​ very good safety profile, concluded Dr .​
Noujaim .​
Then he added something which bears investigating further, There is​ the​ very original (ovarian cancer) patient who was injected in​ 1987 .​
She’s in​ Germany, and​ according to​ Dr .​
Baum she was still alive a​ year ago .​
That’s nearly nine years later! It’s a​ matter of​ great pride for​ me that some people who received OvaRex® MAb are alive today, he said.
While the​ company has licensed, under a​ royalty agreement, the​ OvaRex® MAb technology to​ United Therapeutics, through that company’s subsidiary, Unither Pharmaceuticals, ViRexx has retained rights to​ most member nations of​ the​ European Union and​ certain other countries .​
Key ones include France, the​ United Kingdom and​ the​ Benelux countries .​
ViRexx has also established strategic relationships with Dompé Farmaceutici, Medison Pharma, Ltd .​
and Genesis Pharma S.A .​
for certain European and​ Middle-East Countries.

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