Hyam Levitsky

A four part interview with  Hy Levitsky M.D., professor of oncology and tumor immunology at Johns Hopkins Medical School and co-inventor GVAX anti-cancer vaccine, is posted on Dendreon Investor Village website.

Interview conducted by rufustoehee, a dentist and Dendreon investor, published 4/22/2009.

By way of introduction, Dr Levitsky’s bio is posted alphabetically downpage among those of other speakers at Cancer Immunology & Immunotherapy 2008: From Discovery to Development to Drug.

EXCERPTS FROM INTERVIEW

Conversation with Dr. Levitsky Part 1
“. . . . how this impacts on the field of tumor immunology, I feel it will very much depend on the nature of the data they present, assuming for the sake of discussion, that this is an unequivocal and unambiguous win, then I think it will have a very significant impact. Number one, I think that unless there are aspects to this that have not been made public, I think the FDA would in this instance need to move it forward in the approval process and I think that how it ultimately gets integrated into clinical practice will be a fascinating thing to watch.

“. . . . It is important to acknowledge that tumor response is a surrogate endpoint. It is a surrogate endpoint for perhaps 2 other endpoints that might be more meaningful. One is overall survival which is the gold standard and the other perhaps is the quality of life. No one can argue that those two things have sort of the paramount importance where as to an objective 50% or greater reduction in the mean diameter of all measurable tumor masses is an interesting yard stick, but it is only a yard stick.”

Writer JG Ballard died yesterday aged 78 of prostate cancer. “Despite being diagnosed with advanced prostate cancer in 2006,” Chris Watt reports in the UK Herald “he kept well enough to pen an autobiography, Miracles of Life, in 2008.” BBC –putting his obituary in the entertainment section –pointlessly bowdlerizes the nature of Ballard’s illness, claiming “His agent Margaret Hanbury said the author had been ill ‘for several years’ . . . .” Ballard made no secret of prostate cancer. Others have claimed that he began Miracles of Life because of it.

Kurt Donsbach, 73, who markets supplements including some for conditions of the prostate, was arrested April 8 during his internet radio show “Let’s Talk Health” on a warrant charging him with 11 felonies including treating patients without a license, misbranding drugs for sale, grand theft, unlawfully dispensing drugs as a cure for cancer and falsely representing a cure for cancer. Bail was set at $1,500,000.

A San Diego news site reports: “District Attorney Bonnie Dumanis said that Kurt Walter Donsbach, 73, “preyed on vulnerable patients who were looking for medical help.”

Arraigned April 13, Donsbach plead not guilty in San Diego’s downtown Superior Court. Bail was lowered to $250,00.

Discovery & Challenge: The State of Prostate Cancer Research
A Roundtable Discussion with Leading U.S. Experts

Alvin Chin, Prostate Cancer Survivor & Advocate, Virginia Prostate Coalition, joins  oncologists Howard Scher MD, Donald S. Coffey, PhD,  Peter S. Nelson, MD and representatives from research and the Pharma industry  for a round table discussion April 23.

You can make your voice heard by joining the conference by phone and emailing questions during the Q&A period.

Hosted by the Prostate Cancer Foundation, this round table discussion will feature commentary from eight U.S. experts in the field of prostate cancer research and treatment. The program will focus on the following areas:

* The current prevalence of prostate cancer
* Reaching beyond the PSA screening debate
* Promising scientific breakthroughs
* Challenges ahead for research and discovery
* Funding for continued research
* Models for furthering progress

WHERE:
The National Press Club – First Amendment Lounge
529 14th Street NW, Washington D.C.

and via telephone access

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.

Received from Halle Tecco, founder of YOGA BEAR, a non profit offering free yoga classes for cancer survivors:

Hello, my name is Halle and I’m the Executive Director of Yoga Bear, a non-profit that provides free yoga to cancer survivors across the US, through 125 partner yoga studios.  Most of our participants are female, and we’re trying to get more men involved! Since prostate cancer is so common for men, we wanted to reach out to your organization.  Could you please let your community know that we offer free passes to yoga studios for survivors interested in trying yoga?
Thank you,

http://www.yogabear.org/
blog.yogabear.org http://blog.yogabear.org

Abstracts for presentations to be made at this year’s annual general meeting of ASCO, The American Society of Clinical Oncology, are now online.

For prostate cancer abstracts go to Genitourinary Cancers Symposium and browse 226 titles under

Early/Localized disease, Locally Advanced/Recurrent/Advanced disease, and Biology

and 224  titles under

Epidemiology, Risk factors, Prevention, and Health Services Research

The meeting is scheduled for May 29-June 2 | Orlando, FL. The overall theme of this year’s meeting is “Personalizing Cancer Care.”

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.

On December 24, 2008 the US Food & Drug Administration granted tentative approval to Accord Healthcare’s bicalutamide.

Accord is a subsidiary of Intas Pharmaceuticals, Ltd., an Indian company. Accord’s function is licensing and marketing.