Clinical Trial in Prostate Cancer Patients Planned for Generic Form of Trelstar

Clinical Trial in Prostate Cancer Patients Planned for Generic Form of Trelstar

Xbrane Biopharma announced that it will conduct a clinical trial in prostate cancer patients to assess Spherotide, its one-month generic formulation of Trelstar (triptorelin), to support its plans to submit a Marketing Authorization Application (MAA) to the European Union for approval.

The single clinical study was advised by the German Federal Institute for Drugs and Medical Devices (BfArM), which reviewed the clinical and regulatory aspects of the company’s MAA for the generic.

The active substance in Spherotide is triptorelin, a molecule similar to the gonadotropin-releasing hormone (GnHR), that is used to treat hormone-responsive cancers, such as prostate cancer. Spherotide encapsulates triptorelin in biodegradable microspheres that degrade in the body after the its subcutaneous or intra-muscular injection. The microspheres allow for a controlled release and a long-acting effect, the company said in its press release.

In the clinical trial, expected to enroll 150–170 prostate cancer patients and start in the first half of 2017, the efficacy of Spherotide will be evaluated primarily according to the levels of testosterone suppression seen in patients — with a goal of lowering them to under surgical castration levels — by day 28. A number of secondary endpoints will also be assessed.

Preclinical studies in male rats showed that Spherotide has a similar effect in reducing testosterone levels as Trelstar.

“We are happy to gain support for our regulatory and clinical strategy in discussions with BfArM,” said Martin Åmark, CEO of Xbrane Biopharma. “The advice was pragmatic and concrete and we are very confident that the discussed thresholds for efficacy are achievable. This allows us to proceed with all activities required for finalizing the MAA for the European Union.”

Trelstar is marketed in Europe as Decapeptyl, and according to Xbrane, Spherotide is the only generic triptorelin formulation being readied for market approval as a prostate cancer treatment.

If granted, the MAA will allow Xbrane to make Spherotide commercially available across much of Europe, and will facilitate a similar process in other regions. The generic is not approved by the U.S. Food and Drug Administration.

Xbrane is also developing a three-month formulation of Spherotide.

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Joana brings more than 8 years of academic research and experience as well as Scientific writing and editing to her role as a Science and Research writer. She also served as a Postdoctoral Researcher at the Center for Neuroscience and Cell Biology in Coimbra, Portugal, where she also received her PhD in Health Science and Technologies, with a specialty in Molecular and Cellular Biology.

One comment

  1. Jonathan Roid says:

    It is always good to see news like this, we need more options when it comes about a topic like this. I am against surgery, my urologist offered it to me as the only option but I just didnt want to so I talked to some of my friends and one of them introduced me to his doctor and he told me surgery is not the only option, He prescribed me a supplement named alpharise that has good components for the prostate such as zinc, vitamin B9 and others, also told me I needed to quit many bad habits such as smoking ( The other doc didnt tell me about it), I can tell based on my own experience that surgery is not the only option and if you want to try with a natural treatment try with a better alimentation, better habits and alpharise.

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