Ongoing Clinical Trials That Would Shape the Prostate Cancer Market

December 2, 2012 by  
Filed under Prostate Cancer News

There are many novel drugs like Zytiga (abiraterone), Jevtana (cabazitaxel), and Taxotere (docetaxel), etc, that are already shaping the prostate cancer market.

These medications have been effective in treating the symptoms of prostate cancer in various stages. Most significantly is the fact they have really boosted the market value of the manufacturers in the stock market.

In line with these drugs, there are also clinical trials for different prostate cancer medications that are significantly promising both for the patients and the value of the manufacturers.

Below are highlights of prostate cancer drugs showing promise in clinical trials:

This is the second article in a two part series about ongoing changes that will shape the prostate cancer treatment market going forward. In Part 1 we examined new, recently approved therapies that are already reshaping the market. Part 1 can be found here. In this second part we turn to the future and examine the most promising clinical candidates being developed to treat prostate cancer, as well as the prospects for the companies that are developing these treatments.

According to ClinicalTrials.gov, hundreds of prostate cancer clinical trials are underway to investigate drug, device, biological, preventive behavioral, and nutritional interventions, underscoring the market potential for effective prostate cancer treatments. Among drugs, a handful of therapies merit recognition due to their potential impact on the prostate cancer market, though a plethora are in early-to-mid clinical trials. The majority of the drugs in clinical development are focused on hormone resistant prostate cancer. Table 1, at the end of this article, lists the major pharmacological development programs for prostate cancer.

Takeda’s (TKPHF.PK) Tak-700 (orteronel), a selective inhibitor of 17,20 lyase, is being evaluated in Phase II and Phase III clinical trials. Ongoing Phase II trials are evaluating Tak-700 safety and efficacy in hormone responsive prostate cancer patients. Safety data have revealed that common side effects were fatigue, nausea, and constipation. The primary objective of the efficacy studies is to evaluate PSA levels. Tak-700 has allowed all patients to achieve a 50% or greater decline in PSA levels at doses of 300 mg, 400 mg, and 600 mg, however it is important to note that decline in PSA has not historically correlated with an extension of overall survival. The success of Tak-700 will ultimately hinge on improvements in progression free survival and overall survival. One Phase III clinical trial is evaluating the drug’s effectiveness in chemotherapy-naïve mCRPC patients, while the concurrent second trial is evaluating it in mCRPC patients who are refractory to Taxotere. The results of these studies will weigh in heavily on Tak700′s likely position in the prostate cancer market.

OncoGenex Pharmaceuticals (OGXI), in partnership with Teva Pharmaceuticals (TEVA), has two Phase III studies underway to evaluate custirsen (OGX-011), an mRNA oligonucleotide antisense therapeutic agent targeting clusterin, as a treatment for patients with mCRPC. Clusterin, the target protein, is over expressed in tumor cells, and plays an important role in treatment resistance, including chemoresistance. The first study (Synergy) will examine efficacy of custirsen in combination with Taxotere in patients who are hormone refractory but have not been treated with chemotherapy. Patients will be treated with Taxotere q3 weeks in combination with prednisone (5mg qd) and weekly infusions of custirsen (640 mg) or with Taxotere and prednisone alone. The primary outcome for the trial is overall survival and the secondary outcome is progression free survival at day 140. Other outcomes are progression free survival at day 225, PSA measurements, and safety. The study has completed enrollment and results are expected by end of 2013.

The second study (Affinity) will investigate the effect of custirsen in combination with Jevtana in mCRPC patients whose disease progressed after receiving Taxotere treatment. Patients will receive Jevtana (25 mg/m2 q3 weeks) and prednisone (5mg qd) with weekly infusions of custirsen (640 mg) or will receive Jevtana/prednisone alone. The primary outcome is overall survival while the secondary outcome is progression free survival measured at day 140. The results are expected by late 2015/early 2016. If shown to improve the efficacy of Taxotere and Jevtana in extending the survival rates in patients, custirsen may become a profitable drug once it is approved.

Additionally, OncoGenex is evaluating an antisense therapeutic, OGX-427, and has reported Phase II clinical data for the treatment of chemotherapy-naïve metastatic hormone refractory prostate cancer patients. Preliminary results show that patients co-treated with OGX-427 and prednisone had declining PSA levels and less disease progression at 12 weeks when compared to the prednisone arm. Furthermore, the company is intending to initiate an additional randomized Phase II study evaluating OGX-427 in combination with Zytiga and prednisone compared to Zytiga and prednisone alone. Though the Phase II OGX-427 data seems encouraging, with only PSA data available it is too soon to value it as a potential market mover.

Aragon Pharmaceutical’s ARN-509, an androgen antagonist, is currently in a Phase II clinical trial. The study is investigating the drug’s efficacy in CRPC patients, in treatment-naïve mCRPC patients, and in failed, Zytiga-treated mCRPC patients. These three patient groups were given ARN-509 (240mg qd) for 12 weeks. The primary outcome measure was to determine the percentage of patients in each arm who had a 50% or greater decline in PSA levels from baseline. Preliminary results showed that 88% of the treatment-naïve mCRPC patients, 29% of the failed, Zytiga-treated mCRPC patients, and 91% of CRPC patients had a 50% or more decline in PSA levels. The final data collection date for this trial is set for June 2013.

The Exelixis (EXEL) drug cabozantinib is designed to block MET and VEGF signaling pathways, which are associated with proliferation and invasiveness of tumor cells. Cabozantinib is being evaluated in two Phase III clinical trials, dubbed COMET-1 and COMET-2. The COMET-1 study is enrolling 960 patients with mCRPC who have been treated with Taxotere and Zytiga and/or Xtandi. The trial will compare cabozantinib (60mg qd) to prednisone (5mg bid) and each arm will receive a placebo version of one or the other drug. The primary endpoint is overall survival, while the secondary endpoint will evaluate bone scan responses.

The COMET-2 trial is focused on men with previously treated, symptomatic mCRPC. Patients will be given either cabozantinib (60mg qd) or intravenous mitoxantrone (q3 weeks) with prednisone (5mg bid). The primary endpoint of the trial is pain response and secondary endpoints include overall survival and bone scan response. These trials are expected to report data by early 2013 (COMET-1) and by mid 2014 (COMET-2). Unless Phase III trials demonstrate exemplary early outcomes, it is likely to be three years before cabozantinib can be marketed, making it a laggard in the prostate cancer market.

Tasquinimod, an inhibitor of angiogenesis and metastasis, is Active Biotech’s (ATVBF.PK) lead drug in clinical development. The company recently presented results from a Phase II study that investigated progression-free survival in approximately 200 men with asymptomatic mCRPC. Patients were administered 0.25mg for 2 weeks, 0.5mg for 2 weeks, 1.0 mg for 5 months or were given placebo. The primary endpoint in the trial was disease progression-free survival after six months. The company reported that 69% of tasquinimod treated patients were progression-free after six months compared with 37% for patients on placebo (p<0.001). The median progression-free survival was 7.6 months for the tasquinimod arm and 3.3 months for placebo (p=0.0042). A Phase III trial is currently recruiting 1200 asymptomatic to mildly symptomatic mCRPC patients to confirm the results from the Phase II trial. If successfully approved, tasquinimod may potentially be used to treat mCRPC in the pre-chemotherapy setting. Results are anticipated for late 2013

In addition to Provenge, Dendreon (DNDN) has early Phase I clinical trials underway evaluating a small molecule agonist which activates the calcium ion channel TRPM8. TRPM is highly expressed in solid tumors, especially in advanced prostate cancer tumors, and once activated can allow calcium to enter tumor cells, causing apoptosis. Since the drug is in Phase I clinical trials, it is too soon to tell whether the Dendreon drug will be a market changer. Click here to read more.

Finally, these are some of the most promising drugs for prostate cancer currently in various stages of clinical trials.

When combined with the drugs that are already established, these clinical trials significantly help to boost the value of the prostate cancer market in the coming years.

Some of these drugs are nearing their complete stages and this implies that users would sooner be reaping the benefits of these drugs.

Hopefully, in the nearest future the perfect drugs for prostate cancer treatments would be made available.

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