October 31, 2008

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.

October 30, 2008

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

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

October 29, 2008

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.

October 26, 2008

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 ......?

October 17, 2008

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

October 13, 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….

October 09, 2008

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.
~~~~~~~~~~~~
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!

October 01, 2008

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!