PCa

Eight…..is great?

On Monday I will undergo chemo treatment number 8. Wow, how time flies.

I pray, and ask for your prayers, that my PSA decreases once again. I myself am hoping for a number in the twenties, it was thirty-four on the 13th. As part of the clinical trial I also will need to undergo a bone scan again the following week. Other than the inconvenience, these are really no big deal. What does concern me is the amount of radioactive material that will have been injected into my body this year. This will be my fourth set of scans since the first of the year. With each, as preparation for the bone scan, I have an injection of a radioactive isotope. This is what lights up the hot spots of the scan (x-ray).

Work is busy and now somewhat stressful as our company was just bought out. Yesterday a number of my co-workers were let go. Telecommunications is not a very stable industry to be in at this time. If I had the opportunity I’d go back or switch to health care. For now, I’m relatively guarded from lay offs but only because I am working on a very strategic and successful product. My thoughts and prayers go out to those that were impacted. I have been there before, the stress is unbelievable.
This weekend is supposed to provide ideal Fall weather with temperatures in the seventies.
Of course there will be disc golf tomorrow morning, and likely on Sunday as well – we have to take advantage while the weather is good.

Outraged!!

OK folks, I need your help.
Below is an article that announces a recent change by the Social Security Department inwhich they will accelerate the disability payments for certain diseases. While many types of cancer are included, advanced Prostate Cancer is missing.

As you can imagine, I find this outragous!

If you can find the time, please click here and write to your Senators:
US Senate

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The Social Security Administration Expedites Some Claims for Disability Benefits

Social Security Announces Nationwide Launch of Compassionate Allowances Process Will Fast Track Applications For People with Cancers and Rare Diseases

Michael J. Astrue, Commissioner of Social Security, today announced the national rollout of the agency’s Compassionate Allowances initiative, a way to expedite the processing of disability claims for applicants whose medical conditions are so severe that their conditions obviously meet Social Security’s standards.

“Getting benefits quickly to people with the most severe medical conditions is both the right and the compassionate thing to do,” Commissioner Astrue said. “This initiative will allow us to make decisions on these cases in a matter of days, rather than months or years.”

Currently, getting social security benefits can be a long time process which often does not get “worked out” until after the death of an applicant. Hopefully this process will expedite the process so that people will be able to receive their benefits to which they are entitled when they actually need them.

The expedited decision process is starting out with a total of 50 conditions. The Social Security Administration has stated that, over time, more diseases and conditions will be added to the list of expedited illnesses. A list of the first 50 impairments — 25 rare diseases and 25 cancers — can be found at at the end of this post.

Compassionate Allowances is the second piece of the agency’s two-track, fast-track system for certain disability claims. When combined with the agency’s Quick Disability Determination process, and once fully implemented, this two-track system could result in six to nine percent of disability claims, the cases for as much as a quarter million people, being decided in an average of six to eight days.

“This is an outstanding achievement for the rights of the very sickest in our community. The high number of backlogged cases and appeals has made it a significantly time consuming task to obtain the benefits we are entitled to receive. Hopefully his program will break the log jam and people will be able get on with their lives.

“Unfortunately, many hardworking people with cancer may not only face intensive treatment to save their lives, but they may also find themselves truly unable to perform their daily work-related activities and as result, may face serious financial concerns, such as the loss of income and the cost of treatment,” said Daniel E. Smith, president of the American Cancer Society Cancer Action Network. “The Social Security Administration’s Compassionate Allowances program will help streamline the disability benefits application process so that benefits are quickly provided to those who need them most.”

The list currently includes:
Acute Leukemia
Adrenal Cancer – with distant metastases or inoperable, unresectable or recurrent
Alexander Disease (ALX) – Neonatal and Infantile
Amyotrophic Lateral Sclerosis (ALS)
Anaplastic Adrenal Cancer – with distant metastases or inoperable, unresectable or recurrent
Astrocytoma – Grade III and IV
Bladder Cancer – with distant metastases or inoperable or unresectable
Bone Cancer – with distant metastases or inoperable or unresectable
Breast Cancer – with distant metastases or inoperable or unresectable
Canavan Disease (CD)
Cerebro Oculo Facio Skeletal (COFS) Syndrome
Chronic Myelogenous Leukemia (CML) – Blast Phase
Creutzfeldt-Jakob Disease (CJD) – Adult
Ependymoblastoma (Child Brain Tumor)
Esophageal Cancer
Farber’s Disease (FD) – Infantile
Friedreichs Ataxia (FRDA)
Frontotemporal Dementia (FTD), Picks Disease -Type A – Adult
Gallbladder Cancer
Gaucher Disease (GD) – Type 2
Glioblastoma Multiforme (Brain Tumor)
Head and Neck Cancers – with distant metastasis or inoperable or uresectable
Infantile Neuroaxonal Dystrophy (INAD)
Inflammatory Breast Cancer (IBC)
Kidney Cancer – inoperable or unresectable
Krabbe Disease (KD) – Infantile
Large Intestine Cancer – with distant metastasis or inoperable, unresectable or recurrent
Lesch-Nyhan Syndrome (LNS)
Liver Cancer
Mantle Cell Lymphoma (MCL)
Metachromatic Leukodystrophy (MLD) – Late Infantile
Niemann-Pick Disease (NPD) – Type A
Non-Small Cell Lung Cancer – with metastases to or beyond the hilar nodes or inoperable, unresectable or recurrent
Ornithine Transcarbamylase (OTC) Deficiency
Osteogenesis Imperfecta (OI) – Type II
Ovarian Cancer – with distant metastases or inoperable or unresectable
Pancreatic Cancer
Peritoneal Mesothelioma
Pleural Mesothelioma
Pompe Disease – Infantile
Rett (RTT) Syndrome
Salivary Tumors
Sandhoff Disease
Small Cell Cancer (of the Large Intestine, Ovary, Prostate, or Uterus)
Small Cell Lung Cancer
Small Intestine Cancer – with distant metastases or inoperable, unresectable or recurrent
Spinal Muscular Atrophy (SMA) – Types 0 And 1
Stomach Cancer – with distant metastases or inoperable, unresectable or recurrent
Thyroid Cancer
Ureter Cancer – with distant metastases or inoperable, unresectable or recurrent

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.

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!

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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

#5, 9-2-08

Tomorrow is chemo treatment number five.

We spent Friday night through Sunday noon at my brothers place in Macon, Mo.
We ate really well (grilled glazed salmon one night, smoked chicken with grilled pineapple another)! Brad got to ride the four wheeler all by himself, he was getting pretty good tearing through the mud by the time we left! As in the past I mowed grass for about two hours on Saturday morning and then chopped about a quarter cord of firewood. Strange, but very therapeutic for me.

Last night I finished another book, James Patterson’s “1st To Die”. A very interesting murder – mystery. What I didn’t know before I started the book was that the main character begins a battle with a potentially incurable disease. I have a knack for movies and books with characters like this one. This was the first in a series of six. I bought numbers two and three at Target today.

This morning we played disc golf. I shot four over par at a course we don’t play very often. After I returned home I spent around two hours doing much needed yard work. Tending to the vegetable garden, trimming and fertilizing our roses etc. After that, I spent another two hours painting window frames.

Why bore you with all these details? Just trying to point out that once again, I seem to have fully recovered three weeks after my last treatment.

Here’s to number five; may my tests bring good news and may God grace me with the strength to combat the side effects one more time.

Peace be with everyone.

Hi, remember me?

Back in September 2006, I posted this.

Tomorrow I have to go in for what I am estimating is my 8th bone scan. This is a routine part of the clinical trial I am taking art in, so don’t get worried. There’s not much to it; I’ll go in at 8:00, get injected with some radioactive fluid, then I’ll come back two hours later and lie on an x-ray machine for about 40 minutes and that will be it!

Tuesday I’ll review the results and they my provide me with chemo transfusion number five.

We have a big, busy weekend planned, more details on that in a later post.

Here’s to long weekends, may each of you your Labor Day: be safe and enjoy some time with your family and friends!

54? Let’s make it an even 72!!

Yesterday was a little more that a typical Saturday in August for David. Why let Prostate Cancer and chemotherapy keep you down when you love disc golf?

Joe, Rich and I decided we had talked about a disc golf road trip long enough, it was time to act. We decided we would make a day of it and play in Marshall, MO and two different courses in Columbia, MO.

So yesterday morning Rich and I left my house at 6:00am, picked Joe up and headed 60 minutes east on I-70 to Marshall, MO. They have a great little disc course there, Indian Foothills Disc Golf Course. When we tee’d off a little before 8:00am it was damp, due to heavy dew overnight. Our feet were instantly soaked, and they remained that way for the next 12 hours. This had no impact on our day however! The course was new to Rich and myself and the three of us really had a great time, despite the face full of spider webs each us experienced multiple times. Eww!!!

By 10:30 we were in Columbia, MO at Albert Oakland Park. I love this course. It had been almost four years since I played in Columbia, certainly – BC (before cancer). The threat of rain had long passed, the sky was still overcast but the humidity was typical for an August day in the heartland! Joe shot a nice round at even par and Rich and I finished equal at +3.

Next it was off to the campus of the University of Misssouri and lunch at Shakespeare’s Pizza.
The pie was delicious and with little delay we were off for our next round at Indian Hills Disc Golf Course. The previous time I played this course I really liked it. This time, by the time we reached the back nine we couldn’t wait to leave. I’m all for a challenge, but this course is in need of some serious trimming! There was at least one tree and multiple limbs on every hole that needed to be removed. I even questioned at one point whether the Columbia Parks and Recreation Department owned it or knew how to operate a saw. I’m not whining here, but the condition of this course was ridiculous.

By the time we finished it was only 4:00. We agreed we couldn’t finish on a bad note. A quick phone call to Mary and we were on our way back to Oakland for round four! 72 holes of disc golf in one day!

The last round was perhaps the most fun. We played in less than 90 minutes and finished the back nine in 28 minutes! Joe and I barely missed ace’s on number 16. His shot went right over the top, mine cut right across the front of the basket!

In total, it was an unbelievable day! I haven’t had that much fun playing disc golf since Europe in 2006.

Here are the scores for the day (Par is 54)
Joe – 53, 54, 60, 50 = 217 or +1
David- 61, 57, 64, 57 = 239 or +23
Rich – 57, 57, 70, 57 = 241 or +25

One thing to note – I definitely had an advantage over Rich in one aspect. I had played both courses in Columbia previously. Due to the layout, my experience did not provide an advantage at Oakland however, at Indian Hills, due to the number of blind shots, I had a leg up.

In the end, the scores really didn’t matter. We had a fantastic time, a nice trip and great conversation on the trip home. Thanks Rich and Joe for sharing this day with me. You both are great guys. I wonder where we’ll go next?

EPILOGUE: I was slightly concerned that after all that activity I’d be a little sore today. And of course, Mary shared in my concern. Well I was not fatigued or hurting in the least bit! Take that chemotherapy and PCa!!

Hair today….gone tomorrow?

First, I’m going public with this a little early: my hair is at best ‘thinning’ at worst I’m losing it.
It started last week at some point. I noticed more than normal on my towel and then Tuesday morning Mary said my pillow was covered in hair. It has not started coming out in clumps (that will result in me immediately shaving my head) for now, we’re going with the description of ‘thinning’.
On another note, the Lovenox shots will only have to continue for another two weeks or so. I just talked to Dr. V’s assistant and I will start taking Coumadin (an oral or pill form of blood thinner) tonight. It might take a few weeks to get the dosage correct, so I will have to keep taking Lovenox at the same time.
I slept very little, three hours on Monday night however last night I was out for seven uninterrupted hours. That was a first in weeks, perhaps months!

Click here, sign here!

Today I am writing to ask for your help.

There is a petition that the PCa community is circualting.
On January 20, 2009, a new President of the United States will be sworn in.
On January 21, 2009, that President will receive this petition.

http://www.prostatecancerpetition.org/

Please click on the link above and, after reading it, if you feel compelled to do so, please sign it.
There are currently over 9,000 signatures and we are trying to get to 10,000 by the end of September (Prostate Cancer Awareness Month).

The Dog Days

We spent the weekend at the Lake of the Ozarks and it was HOT! The temperature was in the upper 90’s all weekend but the worse part was at night and in the evenings it was so humid sitting outside was not even an option.

Some how, we had a good time anyway. We shopped, just a little, and went out for a few good meals. The most fun was at the water park. We were there for almost five hours and wiped out when we left. The heat is supposed to break tomorrow and last through the weekend.
Mary and I are hoping to get in another long weekend before Labor Day but we’ll have to see.

While there I finally started a new book. I am reading “A Thousand Splendid Suns” by Khaled Hosseini (he wrote the Kite Runner). I’m almost finished and must say that it is quite good. A much different story than the Kite Runner. It takes place in Afghanistan and though this one did not make me cry, it is equally as engrossing. I should finish it tonight or tomorrow.

My brother is recovering at home after having his gall bladder removed last week. Apparently the stone was the size of an egg and the bladder so swollen it was pushing into his liver. It was quite painful but after a few days he’s much better.

My blood test results are due at any moment, I’ll post tomorrow