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What is the Significance of Urocidin to Cure Bladder Cancer

Bladder cancer is the fourth most common cancer for men (1) and increasingly more men are diagnosed than women. However, studies have shown a women’s prognosis for bladder cancer is worse than men, more likely have advanced tumors, and particularly for African Women poor outcomes 2 In the United States and Europe each year nearly 203,000 new cases of bladder cancer are diagnosed: “Approximately 70% of these (140,000) are diagnosed with non-muscle bladder cancer (Superficial – When tumor has not spread or grown into the main muscle layer of the bladder. 3), and between 50-60% will have a recurrence in their lifetime.” The majority of people diagnosed with bladder cancer 65 – 85 years old, risk increases with age. In 2001 direct cost (USA) related to bladder cancer expenditures totaled almost $3.7 billion (fifth most expensive cancer). 4 In April 2009, The Food and Drug Administration granted Fast Track study (designation during a phase three study) for new medication (Urocidin) treatment of non-muscle invasive bladder cancer in patients who do not respond to current standard therapy. 5

The bladder is an organ located in the lower abdomen. The organ functions to store liquid waste called urine produced by the kidney. Urine passes from the kidney to the bladder through a tube called the ureter. The bladder can hold about two cups of urine. 6 When the bladder is full, muscles in the bladder harden to allow urination. 7 When urination takes places for women, urine passes through the urethra that leads to the vagina. For men, the urethra extends longer through the prostate gland and ends at the tip of the penis. 6

Cancer detected in the cells that line the bladder called superficial bladder cancer (carcinoma in situ – early stage tumor that has not spread): This type of cancer is more likely to return after treatment. Cancer that spreads (metastasizes) from the lining of the bladder into a nearby organ such as the uterus or vagina (in women) or the prostate gland (in men) is known as invasive cancer. “It also may include the wall of the abdomen.” When invasive cancer is diagnosed often cancerous cells (from the bladder) will spread to the lymph nodes (lymphoma) or nearby organs, such as liver, lungs or bones: Referred to as disease metastatic bladder cancer, not lung, liver or bone cancer. 7

Risk factors linked to bladder cancer: Smoking, Race (twice as many Whites than African Americans and Hispanics. “Asians have the lowest rate of bladder cancer”), Age (risk increase more as we get older), Work (exposure to toxic chemicals attributed to cause bladder cancer), gender (“Men get bladder cancer 4 times as often as women”), family history of bladder cancer, radiation or certain drug treatment risk bladder cancer, “Arsenic in drinking water has been linked to a higher risk of bladder cancer, and greater risk for developing bladder cancer not drinking enough liquids each day. 8

Onset of symptoms, require diagnostic testing for bladder cancer: Blood in the urine, pain during urination, and “frequent urination or feeling the need to urinate without results.” A physician may choose one or more laboratory tests and physical examination (Rectal or vaginal exam, and checking for tenderness in the abdomen and pelvis): Urine tests (check the urine for blood cancer cells), intravenous pyelogram (small dose of a dye or ionized radioactive material is injected into the blood stream which travels to the bladder. The function of bladder is clearly observed by X-ray for any abnormalities including cancer. 9), and cystoscopy (examination of the bladder by inserting cystoscope through the urethra, while the patient is under anesthesia. During the procedure a sample of tissue maybe removed for testing by a pathologist). 10

Current treatment options for bladder cancer include: surgery (Removal of cancerous section from the bladder, removal of the entire bladder or removal of a section of the bladder), radiation therapy, chemotherapy, biological therapy (Activating the immune system by administering medication to treat the cancer) or a combination of options. 11 “Surgery, alone or along with other treatments, is used in more than 9 out of 10 cases.” 8 Side effects are common for treating bladder cancer, which may require managed care. 11

Bioniche Life Sciences Incorporated (Canadian Biopharmaceutical Company) developed proprietary Mycobacterial Cell Wall – DNA Complex (MCC) trademarked Urocidin for the treatment of bladder cancer. In November 2008, during a meeting of urologists in Santigo Chile, the biopharmaceutical research company presented positive clinical studies (one and two) involving 130 bladder cancer patients treated with Urocidin. Elderly patients (average 73 years old) during the clinical studies noted excellent safety results. 12 Urocidin provides treatment for non-muscle invasive bladder cancer, unresponsive to standard treatment or current standard therapy. In April 2009, the Food and Drug and Drug Administration approved the Canadian Company Fast – Track designation, further study of Urocidin during a Phase three trial. (Data from Phase three program will be expedited for review and licensing Urocidin 13) Phase three study involves two separate studies. 4 The first part of Phase three study the FDA approved the company’s 105 patients, North American clinical trial administering Urocidin. 13 (In March 2009 recruitment of participants was completed 1) Second part of phase three clinical study (Urocidin) includes more than 600 patients in North America and Europe (60 sites). “It is expected that this study will demonstrate that Urocidin is superior to BCG (Medication to stimulate the immune system or cause inflammation of the bladder wall that destroys cancer cells within the bladder 15) in terms of safety and is at least as efficacious.” 4

Disadvantage standard treatment (BCG) for bladder cancer: More than eighty percent of patients discontinue the treatment because of the toxicity. Also, forty percent of treated patients halt treatment because of induced cystitis (Inflammation of the urinary bladder 16). 4

In July 2009, Bioniche Life Sciences sold exclusive right to develop and market bladder cancer drug Urocidin to Endo Pharmaceuticals (USA) – publicly traded company. According to the deal arrangement the Canadian company will receive up-front cash payment of $20 million with a potential for up to $110 million, based upon clinical, regulatory and commercial achievements of the drug Urocidin. “In addition, Bioniche will manufacture the product and receive a transfer price of supply.” 14

Estimated market capitalization for Urocidin: $500,000 to $1.5 billion, contingent upon pricing and market share according to Bioniche management. 4


1.) Bioniche Life Sciences Inc. and Endo Pharmaceuticals Sign Licensing Agreement for Urocidin(TM) – http://finance.yahoo.com/news/Bioniche-Life-Sciences-Inc-prnews-4114080367.html?x=0&.v=1

2.) BCAN – http://www.bcan.org/facing-bladder-cancer/women-bladder-cancer/

3.) What is Bladder Cancer? – http://www.cancer.org/docroot/cri/content/cri_2_4_1x_what_is_bladder_cancer_44.asp

4.) First Patient Treated In Bioniche Life Sciences Inc. (BNC.TO) Phase III Refractory Bladder Cancer Trial 11/8/2006 – http://www.biospace.com/news_story.aspx?NewsEntityId=36451

5.) Bioniche Bladder Cancer Drug Fast Tracked By FDA – http://www.redorbit.com/news/health/493581/bioniche_bladder_cancer_drug_fast_tracked_by_fda/index.html

6.) Detailed Guide: Bladder Cancer What is Bladder Cancer? – http://www.cancer.org/docroot/cri/content/cri_2_4_1x_what_is_bladder_cancer_44.asp

7.) Bladder Cancer – http://www.medicinenet.com/bladder_cancer/article.htm

8.) Overview: Bladder Cancer – What Causes Bladder Cancer? – http://www.cancer.org/docroot/CRI/content/CRI_2_2_2X_What_causes_bladder_cancer_44.asp?sitearea=

9.) What is an Intravenous Pyelogram (IVP)? -http://www.radiologyinfo.org/en/info.cfm?pg=ivp

10.) Bladder Cancer (cont.) – http://www.medicinenet.com/bladder_cancer/page3.htm

11.) Bladder Cancer (cont.) – http://www.medicinenet.com/bladder_cancer/page6.htm

12.) Bioniche Presents MCC Data at the SIU World Uro-Oncology Update in Santiago, Chile – http://www.drugs.com/clinical_trials/bioniche-presents-mcc-data-siu-world-uro-oncology-update-santiago-chile-6298.html

13.) Bioniche Bladder Cancer Drug Fast Tracked By FDA – http://www.redorbit.com/news/health/493581/bioniche_bladder_cancer_drug_fast_tracked_by_fda/index.html

14.) Bionche licenses bladder cancer drug Urocidin to Endo Pharmaceuticals – http://finance.sympatico.msn.ca/investing/news/businessnews/article.aspx?cp-documentid=20714420

15.) Bacillus Calmette-Guerin (BCG) for bladder cancer – http://www.webmd.com/cancer/bladder-cancer/bacillus-calmette-guerin-bcg-for-bladder-cancer

16.) Cystitis – http://en.wikipedia.org/wiki/Cystitis