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Dendreon's Provenge Improves Survival In Advanced Prostate Cancer ...
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PowerRating), the quintessential poster child for stock volatility, has finally reached the climax with the company revealing the much-awaited trial results of its prostate cancer vaccine Provenge.
Tuesday, Dendreon announced that its pivotal Phase 3 study dubbed IMPACT, which evaluated Provenge in men with advanced prostate cancer, met its primary endpoint of improving overall survival compared to a placebo control.
The IMPACT or IMmunotherapy for Prostate AdenoCarcinoma Treatment study, which was conducted under a Special Protocol Assessment agreement with the FDA, enrolled 512 patients. The primary end point of the IMPACT study is overall survival, and time to disease progression is the secondary endpoint.
Detailed results from the IMPACT study will be presented during a plenary session at the American Urological Association's Annual Meeting in Chicago on April 28.
According to the interim analysis results revealed last October, advanced prostate cancer patients treated with Provenge had a 20% reduction in the risk of death, compared to patients treated with a placebo. No safety concerns were observed in the trial. Dendreon at that time said that the trial will be successful if Provenge can reduce the risk of death by 22%, compared to placebo.
Provenge, an investigational therapeutic cancer vaccine belongs to a new class of therapy known as Active Cellular Immunotherapy. It works by stimulating the immune system to recognize a protein known as the prostatic acid phosphatase or PAP, which is found in about 95% of all prostate cancer cells and attacks the cancer cells.
The company intends to file an amendment to its existing Biologic License Application for Provenge in the fourth quarter of this year.
Commenting on the results, Mitchell Gold, the CEO of Dendreon said, "Survival is the gold standard outcome for oncology clinical trials, and overall survival was the primary endpoint of the IMPACT trial. The positive results from this landmark study provide confirmatory evidence demonstrating that treatment with Provenge may prolong survival.
Provenge - A new hope
Though there are a number of potentially curative treatment options for early stage prostate cancer, the main alternatives available to men with metastasized prostate cancer known as Androgen Independent Prostate Cancer or AIPC include radiation, and Taxotere, a chemotherapy drug made by Sanofi-Aventis in combination with a steroid drug prednisone. But these treatments generally are considered to have severe side effects.
Taxotere, which prolongs the life span of men with advanced prostate cancer by 2.5 months, is associated with toxicities such as edema, liver damage, and neutropenia and carries a black box warning. Initially, the prostate cancer will be an androgen dependent tumor, meaning the growth of the tumor will be promoted by male sex hormones, also known as androgens. The male sex hormones such as testosterones are strong tumor promoters. Therefore in early stages, androgen deprivation therapy, which reduces the levels of male sex hormones, will cause prostate cancers to shrink or grow more slowly.
When the prostate cancer becomes metastasized or has spread to the bone or other organs, the tumor growth will no longer be dependent on the male sex hormones or androgen. This stage of prostate cancer is known as Androgen Independent Prostate Cancer or AIPC, which is an advanced form of prostate cancer.
Since there are limited treatment options currently for Androgen Independent Prostate Cancer, Provenge promises a hope for men who are battling advanced stage prostate cancer, without having to suffer the side effects of traditional chemotherapy.
According to some analysts, Provenge has US sales potential of $1 billion. Prostate cancer is the second leading cause of cancer death in American men, next to lung cancer. More than 2 million men in the United States have been diagnosed with prostate cancer.
As prostate cancer sufferers in the U.S. eagerly await the approval of Provenge, the other side of the Atlantic solidified the commercial potential of Provenge early last year. On January 15, 2008 Dendreon was granted a broad European patent covering Provenge and other active cellular immunotherapies. According to the Cancer Research UK, approximately 670,000 men are diagnosed with prostate cancer in the U.K. each year.
Therapeutic Vs. Prophylactic Cancer Vaccines
There are two types of vaccines namely therapeutic and prophylactic. While a therapeutic cancer vaccine is given to patients to treat existing cancers, a prophylactic cancer vaccine is given to healthy subjects to prevent infection with cancer-causing viruses. Merck's (MRK PowerRating) Cervarix, which are approved to prevent cervical cancer, are examples of prophylactic cancer vaccine.
Despite a number of biotech firms investigating cancer vaccines for decades, not a single therapeutic cancer vaccine has been approved by the FDA. In April 2008, U.S. biotech Antigenics Inc.'s (AGEN PowerRating) cancer vaccine Oncophage was approved in Russia for kidney cancer. However, the vaccine is yet to win the US FDA approval because the Phase III trial completed in 2006, which evaluated Oncophage, did not show sufficient efficacy.
Ongoing Provenge Trials
Provenge is also being studied in two mid-stage clinical studies.
-- ProACT (PROstate Active Cellular Therapy) or P07-2 trial in men with metastatic, androgen independent prostate cancer and
-- NeoACT (NEOadjuvant Active Cellular immunoTherapy), or P07-1 trial in men with localized prostate cancer who are scheduled to undergo a radical prostatectomy.
In The Pipeline
Other than Provenge, Dendreon's yet another cancer vaccine, which is at the forefront, is Lapuleucel-T also known as Neuvenge, for breast cancer. According to results published in August 20, 2008 issue of the Journal of Clinical Oncology, in a phase I clinical trial of Neuvenge, four of 18 breast cancer patients who were administered the Neuvenge vaccine had their tumors shrunk or stabilized.
Trp-p8-related compound, known as D3263 is another investigational drug on which Dendreon is "spending fair amount of resources right now." According to Dendreon, D3263 could have therapeutic benefits in lung, breast, prostate and colon cancers. Last May, the company presented pre-clinical data showing that its Trp-p8-related compound, D-3263, could be beneficial in patients with BPH (benign enlargement of the prostate). D-3263 is currently in a Phase 1 dose escalation study evaluating the drug in patients with advanced solid tumors.
According to research reports, there is an enormous market for BPH or benign prostatic hyperplasia as more than 50% of men in their 60s and as many as 90% in their 70s and 80s have some symptoms of BPH. The National Institutes of Health estimates that there are currently more than 28 million men suffering from BPH in the United States. Common symptoms of BPH include urinating problems and in severe cases, urinary tract infections, bladder or kidney damage, bladder stones, and incontinence.
Some of the current treatment options available for BPH are Boehringer Ingelheim's Flomax, Pfizer Inc.'s (PFE PowerRating) Avodart.
Dendreon's other investigational drugs, which are in pre clinical stages include Carcinoembryonic Antigen or CEA, to treat lung, colon and breast cancers, Carbonic Anhydrase 9 Antigen or CA-9, to treat cervical, colon and kidney cancers and Anti-Serine Protease Monoclonal Antibodies to treat various cancers.
Financial Metrics
Ever since its inception, Dendreon has incurred losses. The company's fiscal year ends on December 31. As of December 31, 2008, the company had an accumulated deficit of $563.3 million.
In 2008, net loss narrowed to $71.6 million or $0.79 per share from $99.2 million or $1.20 per share in 2007. As the company does not have any commercial product, all of the revenue generated is collaborative research revenue and license revenue. In 2008, revenue totaled $111 thousand, down from $743 thousand a year before.
DNDN, which has been trading in the range of $2.55 - $10 for the past 52 weeks, is up 175.75%, trading at $20.13 on a volume of 34 million shares.
Additional information:
What are Male Urinary Tract Infections?
Urinary Tract Infection , Male (Treatment)
Male Bladder Infection
Digital Urology Journal: urinary tract infection
HowStuffWorks " Urinary Tract Infection - Medical Dictionary"
Genesis of urinary tract infection in male children
Urinary Tract Infection in Men - Incontinence Symptoms
Urinary Tract Infection in Men - What Is It? - EverydayHealth.com
Urinary tract infection - adults - Overview
Natural Remedy for Kidney Stones, Male Urinary Tract
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