Category Archives: Clinical trials

New Pathway to Potential Therapies for Advanced Prostate Cancer

Dr. Nima Sharifi
Dr. Nima Sharifi

PSA Rising /DALLAS/ – July 25, 2011 – UT Southwestern Medical Center researchers have narrowed the potential drug targets for advanced prostate cancer by demonstrating that late-stage tumors are driven by a different hormonal pathway than previously was thought.

“We have recently discovered that castration resistant prostate cancer (CRPC) is unexpectedly driven by dihydrotestosterone synthesis from adrenal precursors in a pathway that circumvents testosterone,” says Dr. Nima Sharifi, assistant professor of internal medicine and senior author of a  study in Proceedings of the National Academy of Sciences.

“The dominant pathway to DHT synthesis from adrenal precursors in CRPC [castration resistant prostate cancer] follows an alternative route that bypasses T and requires steroid 5α-reductase isoenzyme-1 (SRD5A1),” Dr. Sharifi writes.
Continue reading New Pathway to Potential Therapies for Advanced Prostate Cancer

Phase 3 Trial Underway for MDV 3100 for Advanced Prostate Cancer

In light of favorable results from the Phase 1-2 trial of MDV 3100 for advanced prostate cancer, a Phase 3 trial is enrolling at sites in the US, Canada, South America, UK, Europe, Australia, and South Africa. Results from the earlier trial are published online by the UK medical journal The Lancet. Continue reading Phase 3 Trial Underway for MDV 3100 for Advanced Prostate Cancer

Provenge Trial Ongoing & Recruiting At Eight US Centers

An open-label study of Sipuleucel-T (Provenge) is ongoing at 8 centers across the USA. This is a Phase 2 Study enrolling men with Metastatic Castrate Resistant Prostate Cancer (CRPC).

The aim of this study is to measure the immune responses to treatment with sipuleucel-T (Provenge). All participants will receive the drug. Continue reading Provenge Trial Ongoing & Recruiting At Eight US Centers

Denosumab in Men Receiving Androgen-Deprivation Therapy for Prostate Cancer

Androgen-deprivation therapy is well-established for treating prostate cancer but is associated with bone loss and an increased risk of fracture. Matthew R. Smith and an international team investigated the effects of denosumab, a fully human monoclonal antibody against receptor activator of nuclear factor-{kappa}B ligand, on bone mineral density and fractures in men receiving androgen-deprivation therapy for nonmetastatic prostate cancer. In today’s New England Journal of Medicine, August 20, they report positive results:
Continue reading Denosumab in Men Receiving Androgen-Deprivation Therapy for Prostate Cancer

VA Hospital Botches Prostate Treatments, Report

Today’s New York Times reports:  “A unit in Philadelphia operating with virtually no outside scrutiny botched 92 of 116 prostate cancer treatments over a span of more than six years.” Dr. Gary D. Kao, according to the report, ran a “rogue” cancer unit which covered up botched procedures in which radioactive “seeds” intended for the cancerous prostate landed in the bladder or near the rectum. Dr. Kao’s team rewrote treatment plans, according to the Times, to cover up his bad aim. Continue reading VA Hospital Botches Prostate Treatments, Report

Investor Interviews Hy Levitsky M.D. on Provenge

Hyam Levitsky
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.


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.”
Continue reading Investor Interviews Hy Levitsky M.D. on Provenge

Dendreon to Hold a Conference Call Tomorrow at 9:00 AM ET to Discuss Final Results of Phase 3 PROVENGE IMPACT Trial

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: (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

Neuvenge Breast Cancer Vaccine Phase 1 Results

Results from a Phase 1 study of NEUVENGE, Dendreon’s candidate vaccine for breast cancer, appeared today in Journal of Clinical Oncology. Testing of Neuvenge in clinical trials runs several years behind Provenge, which is in an ongoing Phase 3 trial. Out of 18 patients with advanced breast cancer who received Neuvenge, 1 patient showed partial response for 6 months and 3 patients had stable disease lasting more than a year.
Continue reading Neuvenge Breast Cancer Vaccine Phase 1 Results

HIFU and Chemotherapy Trial in France for Prostate Cancer

Edap TMS SA (EDAP) said it is currently conducting clinical investigations in France under an approved clinical trial combining the company’s Ablatherm-HIFU device with chemotherapy using docetaxel.

The study is a primary treatment therapy program for men suffering from clinically localized but aggressive high risk prostate cancer typically classified as stage T2c. The study began in late 2006 and the company expects to enroll up to 30 men, of which more than 10 have already been treated. More details — press release.

Provenge and Meta-Analysis — Compare Avandia

In submitting Provenge vaccine for the treatment of advanced prostate cancer for fast-tracked FDA approval despite aborting one clinical trial due to failure to meet the primary endpoint, Dendreon relied on meta-analysis of combined data from two parts of a phase III study, D9901. In fact, after the trials failed to meet their primary endpoint, time to progression, they were analysed twice over. Dr. Eric Small presented meta-analyses of impact on overall survival and prostate cancer specific survival and Dr. Daniel Petrylak presented a further analysis or suvival focused on a subset of patients who, when they progressed on Provenge, took Taxotere.
Continue reading Provenge and Meta-Analysis — Compare Avandia