A Dendreon Inc., director, Gerardo Canet, sold over 200,000 stock options in the company on April 14. According to a filing with the SEC (Securities and Exchange Commission), the sale was made “pursuant to a Rule 10b5-1 trading plan.” Such trading plans are set up to defend company insiders from allegations of trading on insider information.
At 9 A:M ET on April 14 Dendreon’s CEO Mitchell Gold told investor analysts that Dendreon’s Provenge prostate cancer immunotherapy vaccine significantly prolongs survival in men with advanced metastatic prostate cancer. The results are “robust” and “unambiguous,” Gold stated.
“The successful outcome from the Phase 3 IMPACT study provides validation of the long-pursued goal of harnessing the human immune system against a patient’s own cancer,” the company stated in a press release April 14.
Mr. Canet’s SEC Form 4 filing was pointed out today by a member of the Dendreon message board at Investor Village. Members discussed whether Mr. Canet may have had a GTC or “Good ‘Til Canceled” order. This is “An order to buy or sell a security at a set price that is active until the investor decides to cancel it or the trade is executed. If an order does not have a good-’til-canceled instruction then the order will expire at the end of the trading day the order was placed.”
The SEC form in question states “The sales reported on this Form 4 were effected pursuant to a Rule 10b5-1 trading plan adopted by the reporting person.”
Dendreon’s prostate cancer vaccine significantly prolonged the overall survival among 500 men with advanced, metastic prostate cancer compared to a placebo, the company said Tuesday.
Results were “robust” and “unambiguous,” a spokesman said during today’s (Tues April 14) company broadcast conference call with biotech investment analysts.
“The successful outcome from the Phase 3 IMPACT study provides validation of the long-pursued goal of harnessing the human immune system against a patient’s own cancer,” Dendreon Chief Executive Mitchell Gold said in a statement.
“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,” Dendreon CEO Mitch Gold said.
The Seattle-based drugmaker said the phase III study of Provenge, known as IMPACT, met its primary endpoint with statistical significance. Details of the study are being withheld so that they can be presented at the American Urological Association’s Annual Meeting in Chicago on April 28.
SEATTLE, April 13, 2009 -Dendreon Corporation (Nasdaq: DNDN) will host a conference call tomorrow, Tuesday, April 14, 2009, at 9:00 AM ET (6:00 AM PT) to review the outcome of the FINAL analysis of its IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B) clinical trial of PROVENGE® (sipuleucel-T), the Company’s investigational active cellular immunotherapy for the treatment of advanced prostate cancer.
Those interested may access the call with the following information:
Time: 9:00 AM ET/6:00 AM PT
Date: April 14, 2009
Dial-in: 1-877-419-6594 (domestic) or +1-719-325-4855 (international)
Webcast: www.dendreon.com (homepage and investor relations section)
A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 888-203-1112 or 719-457-0820 for international callers; the conference ID number is 8182435. The replay will be available from 12:00 pm ET on April 14, 2009 until midnight ET on April 16, 2009. In addition the webcast will be archived for on-demand listening for 30 days at www.dendreon.com.
Recent stories on bisphosphonate side effects might be signaling the advent of a new, superior drug, but will Halozyme’s rHuPH20 enzyme solve the problem of jaw necrosis?
Drug development companies operate within the overall consumer culture. We all want better drugs, better everything. Generic Fosamax (alendronate) now costs just $4 at Wal-Mart, Kroger and other retail pharmacies. What might make right now a better than usual time to get word out to the masses that Fosamax carries some dreadful, if quite rare, risks?
Seven percent of adults and 19 percent of children taking chemotherapy drugs in outpatient clinics or at home were given the wrong dose or experienced other mistakes involving their medications, according to a new study led by Kathleen E. Walsh, MD, assistant professor of pediatrics at the University of Massachusetts Medical School, and published in the January 1, 2009 issue of the Journal of Clinical Oncology.
Degarelix (generic name) is a GnRH receptor antagonist. The company says: “Degarelix achieves medical castration differently than LHRH agonists, specifically by binding reversibly to GnRH receptors on cells in the pituitary gland, quickly reducing the release of gonadotropins and consequently testosterone.” How quickly? Like this :
Degarelix versus Lupron Effect: Percent drop in Testosterone drop over 28 days
Chicago urologist Gerald Chodak MD has launched an innovative doctor-to-patient series of videos. “This is an evidence-based site,” Dr. Chodak says, “aimed at providing free information in an easier format than the usual sites that require reading. Over 60 videos are now completed on every aspect of this disease.”
Many factors can adversely affect sexual performance. Physical disability illness, obesity, medications, aging, stress, grief, emotional distress and relationship conflicts may all at times contribute to sexual dysfunction.
Prostate cancer diagnosis and treatment may also contribute to sexual dysfunction. To help men and their partners cope with and manage sexual dysfunction, the Krongrad Institute has brought in Rhonda Fine, PhD, ARNP. Dr. Fine will head up the Institute’s efforts to support men and their sexual partners after prostate cancer diagnosis and treatment.
BY CHARLES (CHUCK) MAACK – Prostate Cancer Advocate
In opening: The capability to have an erection does not define what constitutes the title “Man.”
I’ve become exasperated reading of men claiming they are less a man because they are unable to get an erection or have lost libido/potency. “I’m less a man,” “I’m a eunuch,” “I’m a girly-man.”
Where in God’s name have such ridiculous thoughts come from? This, in my mind, is the perfect example of some men’s brains being enclosed within their penis rather than in their head.
I can agree that loss of capability for erection plus loss of libido are blows that strike at key capabilities associated with being a male.
But I am absolutely no less a man than I was through all the decades of my life before discovery of the prostate cancer made it necessary for me to take medical treatments that resulted in my loss of libido/potency/erection.
