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.
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Data presented today from an ongoing study designed to explore the biologic and clinical activity of cancer immunotherapy sipuleucel-T, or Provenge, in patients with early stage recurrent prostate cancer who have a rising serum prostate specific antigen (PSA) level, but who have not yet developed metastatic disease are not all that impressive. The study showed that sipuleucel-T did not significantly delay the time it took for a patient’s PSA to reach a value of 3 ng/ml, the primary endpoint of the study, but it did show a prolongation in prostate-specific antigen doubling time (PSADT). An “early trend” toward slowing the time to metastatic disease for patients who received sipuleucel-T compared with those who received placebo “did not reach statistical significance.”

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A company in Hanover, Germany, Vakzine Projekt Management, reports positive clinical trial results with their therapeutic prostate cancer vaccine VPM4001. The results will be presented at the annual meeting of the American Society for Clinical Oncology (ASCO) in Chicago, USA.

A clinical phase I/II study with 30 patients completed in 2006 showed that 73% of patients suffering from advanced, hormone-resistant prostate carcinoma responded positively to the VPM4001 therapy. The primary study parameter, the PSA doubling time, was increased from 63 days to 114 days on average. This promising result has a high statistical significance (p=0.0035), the company says. PSA doubling time is a surrogate parameter well correlated to survival: higher PSA doubling times mean higher probabilities to survive a five year period. In this trial, the median survival time came to 981 days.
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From ASCO annual general meeting, 2007, comes this abstract of a study by A. Reichle, B. Walter, A. Berand, M. Vogelhuber, K. Bross, J. Wilke, W. Wieland, R. Andreesen, S. Rogenhofer.

Background: The present multi-centre phase II study was designed to support the hypothesis that networking agents binding to ubiquitous accessible targets in metastatic hormone-refractory prostate cancer (HRPC) may counteract neoplasia-specific aberrant cellular functions, thereby mediating objective response (primary endpoint).
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Cougar Biotechnology’s once-daily oral drug CB7630 (abiraterone acetate), based on recently announced trial results, appears o have some efficacy at two stages of the standard treatment path for androgen independent prostate cancer — either before or after chemotherapy.

A UK Phase I/II trial of CB7630 reports positive signs among a small number of patients enrolled so far in a trial for AIPC men who have never taken chemotherapy but have taken LHRH analogues and multiple other hormonal therapies, including antiandrogens, diethylstilboestrol and dexamethasone. In addition, a Phase II trial ongoing at several US centers and in the UK indicates that CB7630 may benefit some patients who have used up Taxotere (docetaxel) chemotherapy.

CB7630 (abiraterone acetate) is reported to have “minimal toxicity” (as yet no maximum tolerated dose has been reached). Among the small numbers of patients treated so far, benefits include lowering of PSA’s, some tumor shrinkage, and some pain reduction. In one of the trials, out of “20 evaluable patients with measurable tumor lesions, treatment with CB7630 resulted in partial radiological responses (as measured
by the RECIST criteria) in 11 patients (55%), with 7 patients demonstrating ongoing stable disease and 3 patients experienced regressing bone disease.”

The company says CB7630 “has the potential to be used by both urologists who treat patients with second line hormonal therapies and by medical oncologists who treat patients in the second line chemotherapy setting…” To that end, the company chose to announce results at AACR, aiming the presentation toward oncologists, and again at AUA:

Cougar Biotechnology Announces Interim Phase II Results Confirm
Efficacy of CB7630 in Both Chemotherapy Naïve and Chemotherapy
Refractory Prostate Cancer Patients April 17 (posted May 31) 2007.

Cougar . . . Presentation of Positive CB7630 (abiraterone acetate)
Clinical Data at AUA Annual Meeting May 21 (posted May 31), 2007

For three UK and US trials ongoing see:
clinicaltrials.gov/ct/search?term=CB7630&submit=Search

This investigational drug is moving ahead in Phase III trials for late-stage chemotherapy resistant ovarian cancer. A company press release says findings from a study to be presented at the New Zealand Society of Oncology meeting May 9-11, “help explain the mechanism by which phenoxodiol induces cancer cell death.” More at Marshall Edwards Announces … Investigational Drug Phenoxodiol Targets Cancer Protein, Causing Cancer Cell Death May 1, 2007.

Dr. Maha Hussain (left) is calling for an open access program for Dendreon’s Provenge prostate cancer vaccine (Sipuleucel-T) pending completion of an ongoing, 500 man clinical trial, She made this suggestion March 29 during the FDA Advisory Committee hearing after voting “No” on the vaccine’s efficacy. She followed up with a letter to the FDA reiterating her “No” position and again calling for an open access program.

Dr. Hussain is the second oncologist among 4 members of the panel who voted “No” to the efficacy of the drug who has followed up with a letter to the FDA.
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Ambrilia, a Montreal company, said today that results of a Phase I/II trial of PCK3145 in patients with metastatic prostate cancer show that the drug, a small molecule peptide, slows patients’ tumor doubling time..

Previously, detailed Phase I results were presented at ASCO and are online: Slovin, S., et al. Phase I trial results of PCK3145 in patients with castrate metastatic prostate cancer – the US experience. ASCO Prostate Cancer - San Francisco, California, U.S.A., February 2006.

“It was a great shame,” a correspondent writes, “that the lead investigator for the first Provenge pivotal trial, Dr. Eric Small, had his flight cancelled by his airline so he was not able to join the panel in time. Dr. David Penson, however, has been an investigator on all three clinical trials for Provenge. During the public commentary section, he clearly articulated how his patients benefited. Dr. Penson came to the CTGT public commentary meeting of his own accord and did not discuss his testimony with the sponsor.”
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Cell Genesys says the 22 patients in their Phase 2 trial of GVAX who received the most effective tolerable dose — “the dose that is comparable to that being employed in the company’s ongoing Phase 3 program”– reached median survival of 35.0 months.

This trial enrolled men with hormone refractory prostate cancer. Cell Genesys previously reported final median survival results from its first multi-center Phase 2 trial of GVAX as 26.2 months.

“The survival results from the two, independent multi-center Phase 2 clinical trials compare favorably to the previously published median survival of 18.9 months for metastatic hormone-refractory prostate cancer patients treated with Taxotere(R) (docetaxel) chemotherapy plus prednisone, the current standard of care for these patients. The company’s ongoing Phase 3 program is designed to confirm this potential survival benefit for GVAX immunotherapy for prostate cancer.”

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The FDA appointed advisory committee on whether to recommend approval for Dendreon’s Provenge (sipuleucel-T) met in Washington, D. C. on March 29th. After voting unanimously to recommend Provenge as “reasonably safe,” the 17-member panel fell short of unanimity on whether the drug is effective. The first 4 votes were against. Following intervention by an FDA official, 13 members voted in favor. Accounts vary as to how and why the FDA official intervened during the vote.
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Clinical trials of Trovax vaccine include a small Phase II trial for prostate cancer, which began in Texas in 2006. This trial was designed for:

* Hormone-refractory prostate cancer
* TroVax administered either as a single agent or in combination with GM-CSF
* Recruitment was completed in July 2006
* To date 85% of patients treated with TroVax mounted an immune response

This Phase II trial in prostate cancer ran at the Methodist Hospital in Houston with Dr Robert Amato as principal investigator. The trial was designed to enroll 24 men with hormone-refractory prostate cancer who had previously received chemotherapy or had refused chemotherapy and had progressive disease. The trial was open label with two arms (12 patients each) to assess the activity of TroVax alone versus TroVax alongside an approved treatment for prostate cancer, granulocyte macrophage-colony stimulating factor (GM-CSF).
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Federal drug regulators on Tuesday released briefing documents that pose questions about the effectiveness of Provenge (sipuleucel-T), Seattle-based Dendreon Corp.’s experimental prostate cancer vaccine. On Thursday March 29 the Cell Tissue and Gene Therapy Committee (CTGT) will accept submissions from interested parties. The committee will then review the drug and recommend to the FDA that it be approved – or not be approved.

Prostate cancer advocates, acutely aware of the paucity of treatments available for men with hormone refractory prostate cancer, plan to attend the meeting to lobby for acceptance of Provenge.

The FDA committee’s questions pinpoint drug stability, efficacy and safety. A slightly higher rate of adverse events including explained and “unexplained” death (see below) occurred in men who took the vaccine.

FDA’s decision will be based on results of randomized trials, which tested Provenge against placebo (for which a dummy vaccination procedure was used). However, a subset of patients received Taxotere when their cancer progressed — either after Provenge, or after placebo or after placebo followed by a course of frozen-stored vaccine.
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Prostate cancer patients in a trial of Novacea’s DN-101 (Asentar™) plus Taxotere showed longer median survival and fewer serious side effects compared with patients who received Taxotere alone, a study has found. The large, randomized Phase 2 trial reports today that standard chemotherapy for metastatic androgen-independent prostate cancer (AIPC) was enhanced for patients who received DN-101 (Asentar™), which is a new formulation of high-strength vitamin D. The group that received the drug before each chemotherapy session showed some increase in survival. Those given the drug also had reduction of some common side effects of the chemotherapy and of advanced prostate cancer, notably, fewer blood clots. Full Story… read on.

Pertuzamab is a new targeted anti-cancer drug that blocks the human epidermal growth factor (HER) receptor family. It belongs to the class of drugs called monoclonal antibodies (MAbs). According to Dr. David Agus, a researcher involved in a Phase II study reported in this week’s Journal of Clinical Oncology, pertuzumab “shows promise” in extending the lives of patients with recurrent prostate cancer. Pertuzumab did not shrink tumors, though, nor lower PSA’s in any of the 41 “heavily pre-treated” patients enrolled in this trial. And in sixty percent it carried diarrhea as a side effect.

A handful of patients obtained months of stable disease. Comparing patients in this study with records of other patients who, like them, had already used up hormone blockade and taxane chemotherapy, Agus and his colleagues determined that for those who respond to it, pertuzumab extends survival. Full story … read more.

Meanwhile after a similar trial in the UK for men with hormone refractory prostate cancer the researchers declared pertuzumab a failure.
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Medivation, Inc. (Amex: MDV) today announced that preclinical efficacy data on MDV3100, a novel small molecule the company is developing to treat hormone-refractory prostate cancer, will be presented later this month at the Prostate Cancer Symposium, a meeting sponsored by the American Society of Clinical Oncology. A clinical trial will be started this year to test safety, dose levels and side effects on small groups of men with hormone refractory prostate cancer.
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RRTNews reports today that Cephalon says that their pain medication Fentora gives faster pain relief in cancer patients and people with chronic pain conditions.

“Cephalon Inc. (CEPH) reported positive results from two Phase III clinical trials of its drug Fentora, in the treatment of opioid-tolerant patients with breakthrough pain associated with chronic pain conditions as well as opioid-tolerant patients with cancer.”

“Fentora, approved by the FDA in September 2006, is the first pain reliever in seven years to be approved for the management of breakthrough pain in cancer patients who are already taking opioids for underlying, persistent cancer pain. In the earlier clinical trials submitted as part of the Fentora New Drug Application, the company evaluated pain relief at 15 minutes. It usually takes 30-45 minutes for other pain medications to take effect.”

Full story from RRTNews.

Myriad Genetics, Inc. (NASDAQ: MYGN) announced today the results of its multi-center, double-blind, placebo-controlled human clinical trial of MPC-7869 (Flurizan™ R-flurbiprofen) in prostate cancer.

The drug had no side effects but nor did it have any positive effect on the patients’ prostate “ancer. The company will not pursue Flurizan™ further for cancer but will continue to look for other uses, primarily for Alzheimer’s disease.
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ZK-Epothilone (ZK-Epo) is a novel chemotherapy drug currently in clinical trials to see if it has an effect against advanced prostate, ovarian and breast cancer. ZK-Epo may work differently than Taxotere and other taxane drugs. It is being tested against all three cancers at centers across the USA and also in Argentina (for ovarian cancer) and Canada (for breast cancer) .
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ZK-Epothilone (ZK-Epo) is a novel chemotherapy drug currently in clinical trials to see if it has an effect against advanced prostate, ovarian and breast cancer. ZK-Epo may work differently than Taxotere and other taxane drugs. It is being tested against all three cancers at centers across the USA and also in Argentina (for ovarian cancer) and Canada (for breast cancer) .

One of the medical centers now recruiting prostate cancer patients for this trial is Oregon Health and Science University (OSHU). The chief clinical investigator for the OSHU trial is Tomasz Beer, MD.
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