Advanced Prostate Cancer

Relatively Speechless

When the phone rang, I was ill prepared for the news.
Though I was glad to hear the voice on the other end of the conversation, her words have left me numb.
A dear friend of ours in Minnesota has cancer, sarcoma to be specific. He has a rather large tumor on his leg and apparently some metastasis in his lungs. They have an appointment with an oncologist tomorrow and chemotherapy is imminent. Chemo much harder than what I am experiencing.
I pray for them and ask that if you are one to pray to join me.
May God bring you peace and the strength to get through this, we are here if you need us.

7, 617, 54…sorry

First and foremost, sorry for not posting for the last week!

Everything is fine, everything is ‘normal’.

Being week two, my tongue returned to normal and work returned to being hectic.
I spent Wednesday and Thursday in Boston, MA (617 area code) for work. It was a quick but productive trip.

I spent yesterday playing 54 holes of disc golf with most of the members of the Saturday morning gang.
We left at 6:00am for Columbia, MO where we played two rounds; one as individuals, one as two-man teams.
During the first round my brother-in-law almost made a hole-in-one – the disc hit the front rim of the basket from about 275 feet away.
250 feet over water then, BANG! Would have, should have, could have……

Both yesterday, and this week in Boston, were absolutely gorgeous fall days. The trees have turned, the days are cooler and crisp
and winter is right around the corner. With winter’s arrival will come my longing for spring. I have five more chemo treatments, lasting until late
January, a mild and short winter would be a welcome treat.

In the weeks ahead I have treatment #8, new bone and CT scans, a long overdue trip to St. Louis and ……?

Hope, in the future

It has been quite sometime since I provided any updates on PC research, etc.
Frankly, there hasn’t been anything positive to report, as sad as that is.

Yesterday was news that a trial for GVAX was officially cancelled. Another promising drug,
Provenge looks like it is still 12-18 months aways from possible FDA approval.

Not to be a downer, but the outlook for us guys with the advanced disease is not all that promising. That is not to say that I, and guys in my situation are out of options. I’m just saying there are not many promising things on the horizon or many options besides hormone therapy and chemotherapy.

There are a few treatments that are currently being researched, one is Abiraterone. See the press release from Cougar Biotechnology below.
The current clinical trials exclude those that have previously taken ketoconizal, so for now, I’m on the outside looking in. However, since I responded so favorably to the keto, Mary and I are hopeful that this may be an effective treatment for me in the future. It offers an option and it offers hope!

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Positive Phase II Data on Cougar Biotechnology’s CB7630 Presented at Prostate Cancer Foundation Scientific Retreat

Interim Phase II Results Support Efficacy of CB7630 (Abiraterone Acetate) in Advanced Prostate Cancer Patients

LOS ANGELES, Oct 17, 2008 (BUSINESS WIRE) — Cougar Biotechnology, Inc. (CGRB:


cougar biotechnology inc com


CGRB 27.01, -0.18, -0.7%)

today announced that results from an ongoing Phase II clinical trial of Cougar’s investigational drug CB7630 (abiraterone acetate) were presented today at the Prostate Cancer Foundation Scientific Retreat. The Prostate Cancer Foundation Scientific Retreat is currently taking place in Lake Tahoe, Nevada.

The clinical trial of CB7630 was conducted at the University of Texas M.D. Anderson Cancer Center in order to investigate associations between serum and microenvironment (bone marrow) androgen concentrations and response to CB7630. In the trial, CB7630 in combination with prednisone was administered orally, once daily, to patients with castration resistant prostate cancer (CRPC), who had progressive disease despite treatment with LHRH analogues and multiple other therapies. All of the 44 patients who were enrolled in the trial had radiological evidence of metastatic disease with bone metastases. Thirty-eight patients (86%) had at least 10 metastatic bone lesions, 7 patients (16%) had metastases in the liver and 14 patients (32%) had lymph node metastases. Twenty-five (57%) of the 44 patients had received prior treatment with ketoconazole and/or diethylstilbesterol and 38 patients (86%) had received prior treatment with chemotherapy, with 27 patients (61%) having received two or more prior chemotherapy regimens before entering the trial.
In her poster presentation entitled, “Identification of an androgen withdrawal responsive phenotype among patients with castrate resistant prostate cancer (CRPC) treated with abiraterone acetate, a selective CYP17 inhibitor (COU-AA-BMA),” Dr. Eleni Efstathiou from the University of Texas MD Anderson Cancer Center presented data on the 41 evaluable patients treated in the trial. Of the 41 evaluable patients, 21 patients (51%) experienced a confirmed decline in prostate specific antigen (PSA) levels of greater than 50% with a median duration of 6+ months. In addition, 5 patients (12%) experienced PSA declines of greater than 90%. Of the 41 evaluable patients, 24 (59%) experienced an improvement in performance status.
Of the 16 evaluable patients with bone metastases, after 6 months of treatment 4 patients (25%) showed an improvement in their bone scan and 11 patients (69%) showed a stable bone scan. Also, 5 of 5 patients with lymph node metastases showed stable disease after 6 months of treatment with CB7630 and 1 of 2 patients with liver metastases demonstrated a partial radiological response (as measured by the RECIST criteria).

Both serum and bone marrow testosterone levels were measured before and after treatment with CB7630. A decline in both serum and bone marrow testosterone levels to below detectable levels (<10ng/ml) was seen in all patients in the trial. Also, patients with depleted baseline bone marrow testosterone levels (<10ng/ml) appeared to progress earlier when treated with CB7630 (p=0.05) compared to patients with measurable baseline bone marrow testosterone levels. Further examination of the bone marrow biopsies of patients treated with CB7630 in this study revealed both overexpression of androgen receptor and CYP17 overexpression.

Alan H. Auerbach, Chief Executive Officer and President of Cougar Biotechnology, said, “The data from our COU-AA-BMA trial of CB7630 presented at the Prostate Cancer Foundation Scientific Retreat continues to support the potential role of the drug in the treatment of CRPC. We continue to be pleased with the strong evidence of antitumor activity in patients with chemotherapy refractory disease, which represents a significant unmet medical need in prostate cancer.”

Arturo Molina, M.D., M.S., ACP, Cougar’s Chief Medical Officer and Executive Vice President of Clinical Research and Development, added, “We are pleased to present the results of this Phase II study and we are intrigued by its findings. The identification of CYP17 expression in CRPC tumor metastases and observation that both serum and bone marrow testosterone levels decline after CB7630 therapy suggests that treatment with CB7630 results in the inhibition of adrenal and intra-tumoral androgen synthesis.”

About Cougar Biotechnology
Cougar Biotechnology, Inc. is a Los Angeles-based biotechnology company established to in-license and develop clinical stage drugs, with a specific focus on the field of oncology. Cougar’s oncology portfolio includes CB7630, a targeted inhibitor of the 17-alpha hydroxylase/c17,20 lyase enzyme, which is currently being studied in a Phase III clinical trial in prostate cancer; CB3304, an inhibitor of microtubule dynamics, which is currently in a Phase I trial in multiple myeloma; and CB1089, an analog of vitamin D, which has been clinically tested in a number of solid tumor types.

Further information about Cougar Biotechnology can be found at www.cougarbiotechnology.com.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as “anticipates,” “expects,” “plans,” “believes,” “intends,” and similar words or phrases. These forward-looking statements include, without limitation, statements related to the benefits to be derived from Cougar’s drug development programs, including the potential advantages of CB7630 and its potential for use in the treatment of CRPC and in second-line hormone and chemotherapy treatment settings. Such statements involve risks and uncertainties that could cause Cougar’s actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in clinical trials, and drug development and commercialization, including the uncertainty of whether results of prior clinical trials of CB7630 will be predictive of results of later stage clinical trials, including Cougar’s ongoing Phase III clinical trial, COU-AA-301. For a discussion of these and other factors, please refer to Cougar’s annual report on Form 10-KSB for the year ended December 31, 2007, as well as other subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Cougar undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

SOURCE: Cougar Biotechnology, Inc.
Cougar Biotechnology, Inc.
+1-310-943-8040
Alan H. Auerbach, Chief Executive Officer and President
ahauerbach@cougarbiotechnology.com
Mariann Ohanesian, Director of Investor Relations
mohanesian@cougarbiotechnology.com
or
Russo Partners, LLC
David Schull, +1-212-845-4271
David.schull@russopartnersllc.com
Andreas Marathovouniotis, +1-212-845-4235
Andreas.marathis@russopartnersllc.com

Copyright Business Wire 2008

The 504th hour

As we sit in the treatment room this morning, I thought I’d provide a peek into what it is we go through.

This, without exception, is the worst part of the cancer treatment process, in my mind.
It is not all the days and nights of little sleep, filled with stress and worry.
It’s not the scans, x-rays, poking and prodding.
By far the worst part of the treatment process is the 60 minutes (approximately) between the time my blood is drawn and the moment when we are given my PSA number. Perhaps it’s the build up, day after day, week after week, waiting, worrying, anticipating, and questioning, “Did the treatment have an impact this time?”.
Tick, tick, tick…..is the clock even moving? Where are the results? Can I read the look on the doctor’s face when he comes in the room? So, this is what we go through every three weeks (504 hours). Very little conversation, but the stress in the room could be cut with a very dull butter knife.
Did I mention, the nurse dropped off my test results a minute ago?
PSA: 34.47
That’s down from 39.57 three weeks ago!!!!
If you are curious, Mary wins the bet this month.
Even better news, only 502 hours until we have to start this process all over again!
Peace be with you all, enjoy the next 501.75 hours….

Lucky #7

Monday I will undergo my 7th chemotherapy treatment. More importantly we will receive the results for another PSA test. This will determine if the first six treatments are working. To date, the overall results of chemo are marginal. My PSA went down about 25%, but it has not dropped measurably since treatment three.

I hold out hope and pray that the second half of this regime is as well tolerated and more successful.
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I finished watching ‘The Wire’ and I must reiterate that it is by far the best crime drama ever produced. Finishing the series was somewhat of a let down, kind of like finishing a good book…you just don’t want it to end. As a viewer it was easy to become attached to the characters. Again, I can’t recommend it enough.

So now I am faced with a dilemma; what to watch during Dex marathons? I better find a solution before Monday night!

The needles go on, and on, and…

My Oncologist’s Physician’s Assistant called yesterday afternoon with the results of Monday’s blood test.
When it was her, I knew it wasn’t good, as the nurse usually calls.
After increasing the blood thinner dosage to 12.5mg three days a week and 10mg the other four, she had the results. My INR was DOWN from 1.8 to 1.5! WHAT?!!!
She had spoken with Dr. V and he was concerned that perhaps the study drug (Atrasentan) was interfering with the INR number. The short story is this, I could increase the Wafarin yet again, or just suck it up and use the Lovenox exclusively (Lovenox is the thinner I have been self injecting since the clot was discovered in early August).
The choice was easy. I was already getting a little concerned about the large amounts of Wafarin I was taking and going to 12.5mg a day, everyday was not a guarantee that my INR number would ever get to 2.0.
So, just like every morning for the past seven weeks, I got up this morning and stabbed myself in the belly. I’m already bruised from side to side. I can’t imagine how my stomach will look after four more months of this daily ritual!
OK, so the whining about this is over…it’s just another bump in the road!

Why I do this or IINAM, chapter?

I was going through the photos from the golf tournament last night and thought I would use the one on the left. My plan was to post an entry about why I put so much into the annual event. Not to be repetative, but It is not about me (IINAM).
Yes, a cure in my lifetime would be ideal, but not realistic. I hold on to hope however. You see, I do this for the Wes Witchers of the world. Wes was a young father like myself who was also diagnosed with advanced PCa. Wes’ diagnosis was more agressive and we lost him earlier this year. I’ve never met his wife Sheri or his daughters but hope to do so later this month.
Sheri sent me the picture on the right yesterday. One of the daughters races sprint cars on tracks around central Missouri. As you can see, they made a little room on their car for ‘the cause’. I knew nothing about this until I got the photo, I was brought to tears.
And so, this is why I do this…..
[The pictures from the golf tournament are on your right]

Meet my friend Dex

A few milestones yesterday, one personal, one not.
Yesterday I had my sixth treatment of chemo. Although this will continue until the end of January, I am now half way through! The good news is my PSA was down, though only slightly, down is not up!
PSA: 39.57
Other good news, my INR (marker to measure blood thinner pharmaceuticals) was finally up to 1.8. The doc increased my dosage once again and we are pretty certain that the injections in my stomach will be a thing of the past next Monday!
On the other hand the steroids (Dex) woke me at 2:15am…..I never went back to sleep! I’ll be dead tired by 9:00pm or so and am hoping I sleep through the night!
The other milestone was yesterday was the first day of fall. As I’ve written here before I’m not a big fan of fall. Winter is the worst. Fall, except for the beauty of the trees for a brief period, represents death in my mind.
As I let the dog out this morning I noticed our elm tree had almost completely changed to purple and had even began it’s annual dumping of leaves into our backyard. The nights are cooler, the days are shorter and it seems that we went from summer to fall overnight.
Three days and counting until the golf tournament. We still have a lot of loose ends to pull together but I am not concerned that it will all come together and the event will go off without a hitch!

#’s

What I forgot to include in yesterday’s post was an update on the continuing saga of “The Clot”.
For six weeks now we have been trying to get my INR number high enough and stable enough to discontinue self injections of Lovenox. (INR is a blood marker used to determine the level of Wafarin or Coumadin in your blood).
In order to deal with “The Clot” I was put on Lovenox (self injection) and Coumadin (generic is Wafarin). The optimistic early prognosis from the doctors assistant was I would have to continue the self injections for 3, maybe four weeks until my INR reached a level above 2.0. It has now been over six weeks.
Things were progressing quite nicely, but not fast enough, when I reached 1.6 over two weeks ago. Last week we had a set back when it dropped to 1.3, this week it’s up a little to 1.4. My Coumadin dosage was increased again on Tuesday and we are hoping when we see Dr. V on Monday it will be really close to or above 2.0.
The worse side effect of the self injections is bruising at the injection site. So, needless to say, my stomach looks like Mike Tyson used me as a punching bag!
…oh well, life goes on…..

‘Faith’, a different kind

I didn’t mean to let 8 days slip by, but I’ve been a little busy. We are wrapping up the plans for our fourth annual golf tournament and that has been consuming my spare time.

The event is once again sold out! Thanks to a number of generous individuals and companies, we have great player’s packs, many, many raffle items and a list of exceptional live auction items. It is sure to be a great day!

The second and third week after my last chemo treatment have been somewhat ‘normal’. The metallic taste disappeared after about eight days, the fatigue was gone after the first weekend and life resumed, as much as that is possible. My upcoming treatment number on Monday, which will be #6 will mark the halfway point. Already?

On another note, I received the attached story from my friend Tom and thought it was worth sharing. At times God tests us all.
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This dog was born on Christmas Eve in the year 2002. He was born with 3 legs – 2 healthy hind legs and 1 abnormal front leg which need to be amputated. He of course could not walk when he was born. Even his mother did not want him.

His first owner also did not think that he could survive. Therefore, he was thinking of ‘putting him to sleep’. By this time, his present owner, Jude Stringfellow, met him and wanted to take care of him. She was determined to teach and train this dog to walk by himself. Therefore she named him ‘Faith’.

In the beginning, she put Faith on a surfing board to let him feel the movements. Later she used peanut butter on a spoon as a lure and to reward for him to stand up and jump around. Even the other dog at home also helped to encourage him to walk. Amazingly, after only 6 months, like a miracle, Faith learned to balance on his 2 hind legs, and jumped to move forward. After further training in the snow, he now can walk like a human being. Faith loves to walk around now. No matter where he goes, he just attracts all the people around him.

He is now becoming famous on the international scene. He has appeared in various newspapers and on TV shows. There is even a book entitled ‘With a Little Faith’ being published about him. He was also considered to appear in one of Harry Potter movies.

His present owner Jude Stringfellow has given up her teaching post and plans to take him around the world to preach that even without a perfect body, one can have a perfect soul.
In life there are always undesirable things that occur. Perhaps one will feel better if one changes the point of view from another direction.