Claim: Landmark clinical trial shows gene-targeted drug can treat prostate cancer
Verdict: REFUTES

Retrieved passages:
title: Cancer vaccine
text: of a phase III clinical trial. The approval is for a subset of kidney cancer patients who are at intermediate risk for disease recurrence. It awaits approval in the US and EU. but will need a new trial for FDA approval. Interim results from a phase III trial of talimogene laherparepvec in melanoma showed a significant tumour response compared to administration of GM-CSF alone. Oncophage was approved in Russia in 2008 for kidney cancer. It is marketed by Antigenics Inc. Sipuleucel-T, Provenge, was approved by the FDA in April 2010 for metastatic hormone-refractory prostate cancer. It is marketed by Dendreon

title: The Immune Response Corporation
text: one biotech, Dendreon, solved this problem with its prostate cancer treatment.” The team running its facility were experts at producing and distributing the only commercially available cancer immunotherapy, so Novartis purchased the process and the FDA-approved manufacturing facility. Novartis also hired 100 people who were making the prostate cancer immunotherapy and redirected them to the Kymirah CAR-T program. Based on clinical results, the FDA approved Kymriah on August 13, 2017. It was the world’s first gene therapy to reach the market. Its approval was recognized by FDA Commissioner Scott Gottlieb who remarked: “Today marks another milestone in the development of

title: Cancer vaccine
text: Dendreon Corporation announced that their Phase III clinical trial of sipuleucel-T, a cancer vaccine designed to treat prostate cancer, had demonstrated an increase in survival. It received U.S. Food and Drug Administration (FDA) approval for use in the treatment of advanced prostate cancer patients on April 29, 2010. On April 8, 2008, New York–based company Antigenics announced that it had received approval for the first therapeutic cancer vaccine in Russia. It is the first approval by a regulatory body of a cancer immunotherapy. The treatment, Oncophage, increased recurrence-free survival by a little more than a year according to the results

title: Pertuzumab
text: receptors and had begun Phase I trials, aiming for a broad range of cancers, not just ones overexpressing HER2. It was the first known HER dimerization inhibitor. In 2005 Genentech presented poor results of Phase II trials of pertuzumab as a single agent in prostate, breast, and ovarian cancers, and said that it intended to continue developing it in combination with other drugs for ovarian cancer. In 2007 Genentech dropped the trade name Omnitarg. In March 2009 Roche acquired Genentech by buying shares it didn't already control. In 2012 the results were published of the CLEOPATRA trial, a randomized placebo-controlled

title: GenSpera
text: Administration for the treatment of HCC, the most common form of primary liver cancer. The company also holds patents on prodrug candidates that target the prostate-specific enzymes Prostate Specific Antigen (PSA) and Human Glandular Kallikrein (hK2). These candidates are expected to be useful in the treatment of prostate cancer. The active ingredient in G-202 is a chemotherapeutic agent derived from thapsigargin, a plant-based cytotoxin that kills by disrupting the calcium balance in cancer cells. GenSpera's prodrug delivery system keeps the thapsigargin inactive in the body until it finds cells that it has been programmed to seek. Once those cells in

title: H19 (gene)
text: triggered by the presence of H19 transcription factors found only in tumor cells, thus destroying the tumor without affecting normal cells. In a double-center, dose escalation Phase I/IIa clinical trial of BC-819 as a treatment for superficial bladder cancer, no severe adverse events related to the plasmid were detected, and tumor responses were observed in more than 70% of patients, including those with a still not-optimized therapeutic dose and regimen. BC-819 was previously tested in human compassionate use for the treatment of superficial bladder cancer, ovarian cancer and metastatic liver cancer. The bladder cancer patient, who was a candidate for

title: Prostate cancer
text: breast cancer stories for each one covering cancer of the prostate. Prostate Cancer Awareness Month takes place in September in a number of countries. A light blue ribbon is used to promote the cause. MDV3100 was in phase III trials for CRPC (chemo-naive and post-chemo patient populations) and gained FDA approval in 2012 as enzalutamide for the treatment of castration-resistant prostate cancer. Alpharadin completed a phase 3 trial for CRPC patients with bone metastasis. A pre-planned interim analysis showed improved survival and quality of life. The study was stopped for ethical reasons to give the placebo group the same treatment.

title: Sipuleucel-T
text: basic steps: A complete sipuleucel-T treatment includes three courses at two week intervals. Sipuleucel-T is used to treat people with metastatic, asymptomatic, hormone-refractory prostate cancer (HRPC). Other names for this stage are metastatic castrate-resistant (mCRPC) and androgen independent (AI) or (AIPC). This stage leads to mCRPC with lymph node involvement and distal (distant) tumors; this is the lethal stage of CaP. The prostate cancer staging designation is T4,N1,M1c. Sipuleucel-T showed overall survival (OS) benefit to patients in three double-blind randomized phase III clinical trials, D9901, D9902a, and IMPACT. The IMPACT trial served as the basis for FDA licensing. This trial

title: Sunitinib
text: a treatment. Between April 2009 and May 2011 Pfizer has reported unsuccessful late-stage trials in breast cancer, metastatic colorectal cancer, advanced non-small-cell lung cancer, and castration-resistant prostate cancer. The drug was discovered at SUGEN, a biotechnology company which pioneered protein kinase inhibitors. It was the third in a series of compounds including SU5416 and SU6668. The concept was of an ATP mimic that would compete with ATP for binding to the catalytic site of receptor tyrosine kinases. This concept led to the invention of many small-molecule tyrosine kinase inhibitors, including Gleevec, Sutent, Tarceva and many others. Sunitinib adverse events are

title: Ipilimumab
text: were controversial for their unconventional use of a control arm (as opposed to using a placebo or standard treatment). The study tested ipilimumab alone, ipilimumab with gp100, and the vaccine alone. Patients had a higher survival rate with ipilimumab alone, however it is not fully clear whether the vaccine caused toxicity, which would make the drug perform better by comparison. Ipilimumab gained FDA approval in early 2011. In 2008/09 Medarex performed a phase I/II dose escalation clinical trial of ipilimumab in metastatic hormone-refractory prostate cancer (HRPC). Some of the patients with advanced prostate cancer had their tumors drastically shrink, promoting

title: Rosetta Martiniello-Wilks
text: (UTS website article) - "Prostate cancer (PCa) is the most commonly diagnosed cancer among men in Australia and many other western countries. If treated early with surgery, PCa has a cure rate of over 90 per cent. However, once advanced, it is incurable. Dr Martiniello-Wilks with Professor Pamela Russell, CSIRO lead scientists Dr Gerry Both, Dr Peter Molloy, Dr Trevor Lockett and their laboratories, have developed a cutting-edge 'direct delivery method' for advanced local PCa. This Gene Medicine for PCa uses a unique and safe virus to deliver a suicide gene, in a targeted manner, to prostate cells." Martiniello-Wilks is

title: Dennis Slamon
text: convinced Genentec to launch a full scale research and development effort, which concluded in the creating of new more effective breast cancer treatments. For 12 years, Dr. Slamon and his colleagues conducted the laboratory and clinical research that led to the development of the new breast cancer drug Herceptin, which targets a specific genetic alteration found in about 25 percent of breast cancer patients. To acknowledge Slamon's accomplishments, President Bill Clinton appointed Slamon to the three-member President's Cancer Panel in June 2000. A 1975 honors graduate of the University of Chicago's Pritzker School of Medicine, Slamon earned his Ph.D. in

title: Exelixis
text: exploring cabozantinib in other cancers, betting the future of the company on the drug. In 2014 the drug failed a Phase III trial in prostate cancer, and the company laid off 70% of its employees. In 2015 Genentech and Exelixis won FDA approval for cobimetinib for certain forms of melanoma. In March 2016 Exelixis licensed to Ipsen worldwide rights (outside the US, Canada, and Japan) to market cabozantinib. In April 2016 the FDA granted approval for marketing the tablet formulation as a second line treatment for kidney cancer and the same was approved in Europe in October of that year.

title: Oncogenomics
text: to contribute to cancer pathogenesis, but before this study most would not have been candidates for targeted gene therapy. This analysis validated the approach of whole cancer genome sequencing in identifying somatic mutations and the importance of parallel sequencing of normal and tumor cell genomes. In 2011, the genome of an exceptional bladder cancer patient whose tumor had been eliminated by the drug everolimus was sequenced, revealing mutations in two genes, "TSC1" and "NF2". The mutations disregulated mTOR, the protein inhibited by everolimus, allowing it to reproduce without limit. As a result, in 2015, the Exceptional Responders Initiative was created

title: Prostate cancer
text: include PTEN (gene) and KAI1. "Up to 70 percent of men with prostate cancer have lost one copy of the PTEN gene at the time of diagnosis" Relative frequency of loss of E-cadherin and CD44 has also been observed. RUNX2 is a transcription factor that prevents cancer cells from undergoing apoptosis thereby contributing to the development of prostate cancer. The PI3k/Akt signaling cascade works with the transforming growth factor beta/SMAD signaling cascade to ensure prostate cancer cell survival and protection against apoptosis. X-linked inhibitor of apoptosis (XIAP) is hypothesized to promote prostate cancer cell survival and growth and is a

title: Toremifene
text: cancer, and second, a pivotal Phase III clinical trial for the prevention of prostate cancer in high risk men with high grade prostatic intraepithelial neoplasia, or PIN. Results of these trials are expected by first quarter of 2008 An NDA for the first application (relief of prostate cancer ADT side effects) was submitted in Feb 2009, and in Oct 2009 the FDA said they would need more clinical data, e.g. another phase III trial. Ultimately, development was discontinued and toremifene was never marketed for complications associated with ADT or the treatment or prevention of prostate cancer. Toremifene Toremifene, sold under

title: Oncogenomics
text: at the National Cancer Institute. The initiative allows such exceptional patients (who have responded positively for at least six months to a cancer drug that usually fails) to have their genomes sequenced to identify the relevant mutations. Once identified, other patients could be screened for those mutations and then be given the drug. In 2016 To that end, a nationwide cancer drug trial began in 2015, involving up to twenty-four hundred centers. Patients with appropriate mutations are matched with one of more than forty drugs. In 2014 the Center for Molecular Oncology rolled out the MSK-IMPACT test, a screening tool

title: Rucaparib
text: in order to determine how patients with prostate cancer will respond to the rucaparib drug. The studies for these two trials are still going on and the estimated dates for the first results are raging between 2019 through 2022. The ARIEL3 and ARIEL4 are two randomized, double-blind phase III studies. The ARIEL3 study was designed to evaluate the effect of the investigational agent as a maintenance treatment for the advanced platinum-sensitive ovarian cancer patients versus placebo after their response to ≥2 prior chemotherapies. The top-line results from the study were presented at the ESMO 2017 congress and right after that,

title: Ipilimumab
text: further trials. On June 19, 2009, the Mayo Clinic reported two prostate cancer patients involved in a phase II study using MDX-010 therapy who had been told initially that their condition was inoperable but had their tumors shrunk by the drug such that operation was possible and are now cancer-free as a result. This press report however was criticized as premature and somewhat inaccurate. The clinical trials were still at an early stage and were run alongside other treatments – which could have been the real explanation for the tumor shrinkage. It was too early to say whether ipilimumab made

title: Northwest Biotherapeutics
text: operable and inoperable, with the possible exception of prostate cancer. Northwest, having completed Phase II clinical trials for DCVax-Prostate, has received FDA permission to progress to Phase III. The trial is expected to be quite large, and Northwest has sought partners for the endeavor. The DCVax-Prostate process is similar to DCVax-L, but rather than using the patient's tumor as the protein source, it utilizes a synthetic protein that is an analog to a common mutated protein in prostate cancer cells. This method is very different, and expected to be far more effective than the currently approved immunotherapy. Dendreon uses PAP,