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Q&A

Alvaro Morales, MD

Alvaro Morales, MD is a Professor in the Departments of Urology & Oncology at Queen's University in Kingston, Ontario, and a Urologist at Kingston General Hospital. Dr. Morales has served as Principal Investigator for a number of Bioniche clinical studies related to the use of MCC for treatment of bladder and prostate cancers, and the use of hyaluronic acid for treatment of interstitial cystitis.

View Dr. Morales' profile

Much attention these days is being paid to the world's aging population. Are you concerned about this trend?

Let me start by defining middle age. When I was 40, I thought middle-aged was about 60. When I turned 60, I thought middle-aged was about 70, so things change. But the question of the world's aging population is a very serious issue. Coupled with this is the fact that, according to UN statistics, the younger population is decreasing - those under 15 years of age. If the trend continues, we are going to have a tremendous imbalance in 15 to 20 years. Proportionally, there will be a very large population of older individuals that are relatively healthy - much healthier than their parents and grandparents - and a smaller population of younger working people supporting them. I think governments are in for big surprises, and they are not getting ready. We don't see the preparations in place to deal with this huge problem that is going to come very soon.

What are some of the genito-urinary conditions that you see among older individuals?

Well, we see the standard ones, like the enlargement of the prostate. This is exceedingly common. Every man over the age of 40 will have some degree of benign prostatic hyperplasia, or BPH. Not all of them become symptomatic and not all of them require treatment, but everybody will have it. And if we live long enough, by the age of 80, probably 90% of men will have prostate cancer. It is an epidemic. We used to believe that prostate cancer had to be treated, otherwise it would kill the person. The new studies are showing that many of these cancers are fairly benign, and that many men harbouring prostate cancer will more likely die from other causes, not from prostate cancer. Other cancers such as bladder and kidney are malignancies more common beyond middle age. Obviously, the increase in the aging population will result in an overall increase in their prevalence.

With the advent of sildenafil, or Viagra, men began to come out of the woodwork complaining about sexual dysfunction. Not just erectile dysfunction, but all sorts of sexual dysfunction: inability to achieve or maintain an erection, premature ejaculation, difficulties with desire, et cetera. This will continue to be a major concern.

Another area that is very important to me is the issue of hormonal deficiencies in the aging male. Frequently there is a decline in the production of testosterone, although this is not universal. Many men live for years without having the deficiency, but normally, by the age of 40, the production of testosterone will decrease about 1% a year. For many men, this becomes a problem. The manifestations are typical of a lack of testosterone: they develop sweats, irritability, increasing weight, loss of hair, depression, difficulties with sexual function, particularly a lack of desire, and poor quality erections. The treatment of male hormonal deficiencies is very controversial, and there are many concerns with the abuse and the use of hormones; people who are treated without proper diagnosis or without proper follow-up. This is going to be an expanding field over the next few years.

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In the aging female, what are some of the conditions that you are seeing?

Of course, women develop the menopause, and hormonal replacement in women is also a very controversial subject. From the urological point of view, one of the things that we see fairly often is the problem of cystitis. Not necessarily in older women - this may occur in young, middle-aged, and older women. But there are a number of conditions that are more common in older women. One that is very common is urinary incontinence. It may be just a mild type, with a few drops here and there. Some women get very disturbed with even small amounts of urinary leakage. At the other extreme, you have total incontinence where the woman will have to wear pads all the time. Incontinence affects both men and women, but it is much worse for women. The problem is very serious. It requires enormous resources and consumes a large amount of healthcare dollars.

Let's move on to bladder cancer, a common interest for both Bioniche and yourself. Can you describe the disease and its prevalence?

Well, bladder cancer is a very interesting tumour. It is not one of the most common malignancies. It's about fifth or sixth in prevalence in North America and probably in the world. It was one of the first cancers in which a very clear relationship was established between carcinogen exposure, usually with chemicals, and the development of this tumour. Later on, the consumption of tobacco - tobacco smoking - was also identified clearly as a cause of the development of bladder cancer. The numbers are increasing steadily, but we don't have the epidemic with bladder cancer that you can see in prostate cancer. I think, in part, it's because we have better diagnostic methodologies for prostate cancer. But bladder cancer has been steadily increasing, particularly in industrialized countries. It's more often a disease of men than women, usually middle-aged and particularly after the age of 65.

The most common manifestation of bladder cancer is the presence of blood in the urine. Fortunately, the majority of patients who develop bladder cancer will notice blood in their urine, which is a very scary situation, and go to the doctor very quickly. The diagnosis is made relatively early in the vast majority of people. The tumours are still superficial, at a point when they are easy to treat, and easier to cure than the advanced tumours that we see in other conditions.

More information for you and your family about bladder cancer

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How is treatment for bladder cancer carried out? What is the traditional therapy?

Once you make the diagnosis of bladder cancer, it depends on what type of tumour you find, how deeply it has infiltrated into the bladder wall, and how extensive it is within the bladder. Usually, we see people with a few small tumours that can be removed very easily. The problem with bladder cancer is that even with the best surgeon removing all the tumours, there is a tendency for them to recur. About 60% to 70% will come back again within two years. So we have to monitor these patients carefully. They need to be seen at least once or twice a year for about ten years. If there are no recurrences after ten years, I personally feel it is highly unlikely that the tumour will come back and the follow-up can be discontinued.

There is another type of bladder tumour that is called carcinoma in-situ. This is superficial and just covers the lining of the bladder, but it is very dangerous because it has a tendency to suddenly progress very quickly, infiltrate the bladder, and spread outside the bladder, at which point it is not curable. You can treat them, but you cannot cure them.

During the early 1970's, immunotherapy became increasingly popular and many people were trying different types of agents which had immunotherapeutic effect. Some of them proved to be effective in leukemias and lymphomas, but for solid tumours, really there was nothing available. The criteria for immunotherapy to work with a compound called BCG - Bacille Calmette-Guérin - was established in the early 1970's by a group working at the National Cancer Institute in the USA. We started doing some experiments and it turned out that this was an effective treatment. BCG worked extremely well in preventing recurrences, but it worked even better in the treatment of carcinoma in-situ, for which the only treatment available before BCG was removal of the bladder. About 70% of people with carcinoma in-situ will respond very well to treatment with BCG.

The problem with BCG, however, is that it's a live bacterium. When you put live bacteria inside the bladder, it can spread systemically and produce septicemia, which may be fatal. It doesn't happen very often, but when it does, patients get quite sick. So we began to wonder if we could use the same BCG but not as a live bacteria. What would happen if we could kill it? There were many groups simultaneously looking at this. They were radiating the BCG, breaking it into fragments, killing it by heat, using chemicals, et cetera. Once the bacteria was killed, it seemed to lose all efficacy.

And at this point you started looking around for other options?

Yes, our research was continuing but at a very slow pace. Then we found a company called Vetrepharm in London, Ontario that was working on a veterinary product using mycobacterial cell walls, not from BCG, which is mycobacterium bovis. This was from a different mycobacterium - the mycobacterium phlei. They had developed a product that apparently was quite effective in treating tumours in horses, dogs, and cats I believe. I arranged to get a small sample and kept it in the fridge for a few months. One day we contacted Vetrepharm and said we would like to determine if there was an application for their product in human studies. And the first thing we did was to repeat the original model that was used to prove the efficacy of BCG, using this compound. Surprisingly, it proved to be as effective as BCG. I was amazed because the gospel at that time was that you needed live bacteria for BCG to be effective. This product was cell wall fragments from M. phlei. There were no live bacteria present. But it worked exceedingly well. And this is how we started working with the little company that became Bioniche and the compound that is now known as MCC.

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Tell us about your studies using MCC to treat bladder cancer in humans.

After completing an ethics review, we did a phase I study to treat a small number of patients to see how it would work. It seemed to be safe and efficacious. Then we moved into phase II studies at a dose of 4 mg, which is a low dose. It has been calculated according to the efficacy of this compound to kill tumour cells in-vitro. The studies for 4 mg were completed. The studies doubling the dose to 8 mg have been completed as well. The results appear to be a clear dose response increase in the efficacy of the medication. The side effects also increase between 4 and 8 mg, so the decision has been taken that 8 mg should be the upper dose that will be used in the future. One of the great things about MCC that I am enthusiastic about is the safety of it. Some patients develop flu-like reactions as side effects - low fever and things like that. But the dangers and the fear that exist with BCG are completely eliminated.

Moving forward, what will be involved in the upcoming phase III clinical trial?

The protocol for the phase III trial has been completed and is being reviewed by the regulatory agencies. It will be a very large international pivotal study with over 300 patients. There will be centres in North America, both Canada and the United States, as well as throughout Europe. The most reputable centres that have been dealing with bladder cancer for many years are involved in this. I am very enthusiastic about this study. At the same time, you get butterflies in your stomach. That is the problem with research. You never know what is going to happen. But this study should give us all the answers. And I am very optimistic that it's going to work.

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You mentioned prostate cancer earlier. It appears there may be opportunities to use MCC in the treatment of prostate cancer as well.

Yes. Prostate cancer is the most common malignancy in men. Every time you turn around there is a friend or relative who has been diagnosed with prostate cancer. We have done a few clinical studies showing that you can actually inject MCC directly into tissues in humans without any serious side effects. There has been a small phase I study to prove safety in men who were going to have a prostatectomy and agreed to have MCC injected into the prostate before the operation. They were very brave and we have to be very grateful to the people who agree to participate in these studies. It was shown clearly that the compound is very safe. Will it be effective against prostate cancer? We have to wait and see what happens. The thing that we know now is that it is safe. Will it be more difficult to administer than in the bladder? Of course it will be much more difficult. In the bladder, you just have to put a little catheter through the urethra in males or females. For the prostate, you will have to deliver it by some form of an injection that can be given by many different routes. But there is enormous potential that this may work, and the benefits to men, middle-aged and older, could be tremendous.

How would you characterize your working relationship with Bioniche over the years?

It has been a very positive relationship. One of the advantages of working with a smaller company is that you can really deal with the people at a personal level. I wouldn't hesitate to call the President or the senior managers when necessary, and I know there will be an answer at the other end. With large companies, the problem is that you have to go through different layers and it can take forever to get an answer. I think that is one of the reasons we have moved relatively quickly in the development of MCC. It has taken a few years, but things have progressed very smoothly.

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Dr. Alvaro Morales

"A decade ago, the AUA identified conditions of relevance to the specialty. Thus, urological cancers, urinary incontinence, prostatic enlargement and erectile dysfunction were singled out among others as being of particular interest. All are prevalent in aging populations. The growth of this segment poses the greatest health care challenge for the first quarter of this century and beyond."

Comments by Dr. Morales in a lecture to the 26th Congress of the Societe Internationale d'Urologie in Stockholm in 2002

"If we live long enough, by the age of 80, probably 90% of men will have prostate cancer. It is an epidemic."

"The treatment of male hormonal deficiencies is very controversial, and there are many concerns with the abuse and the use of hormones."

"One of the things that we see fairly often is the problem of cystitis. Not necessarily in older women - this may occur in young, middle-aged, and older women."

"We don't have the epidemic with bladder cancer that you can see in prostate cancer. I think, in part, it's because we have better diagnostic methodologies for prostate cancer."

"The problem with bladder cancer is that even with the best surgeon removing all the tumours, there is a tendency for them to recur."

"When you put live bacteria inside the bladder, it can spread systemically and produce septicemia, which may be fatal."

"The gospel at that time was that you needed live bacteria for BCG to be effective. This product was cell wall fragments from M. phlei. There were no live bacteria present. But it worked exceedingly well."

"One of the great things about MCC that I am enthusiastic about is the safety of it… the dangers and the fear that exist with BCG are completely eliminated."

"We have done a few clinical studies showing that you can actually inject MCC directly into tissues in humans without any serious side effects."

"There is enormous potential that this may work, and the benefits to men, middle-aged and older, could be tremendous."

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