TZ101 – A New Product to Improve ED Treatment in Prostate Cancer Patients
Stem cell therapy is one of the promising new ways of treating erectile dysfunction in patients with prostate cancer. It is highly topical as up to 85% of men experience ED after radical prostatectomy. Those undergoing radiotherapy report ED in up to 60-70% of the cases. First-line treatments used to manage ED of other etiologies, such as PDE-5 inhibitors, for example, are not as effective in prostate cancer patients, so researchers continue searching for new therapies.
The Phase I clinical trial of stem cell therapy for ED patients after radical prostatectomy revealed very encouraging results in late 2018. 53% of the participants reported erection hard enough for penetrative intercourse at 12 months after surgery. A solution capable of further increasing the procedure’s success rate seems to be on the way too. It is TZ101 by Targazyme – the product that has recently secured funding for clinical trials provided by The Sexual Medicine Society of North America. The clinical trials will take place in The University of Texas Health Science Center but the starting date hasn’t been announced yet.
TZ101 is an enzyme comprised of α(1,3) – fucosyltransferase VI and GDP-fucose. It is used to treat stem cells before they are injected into the corpora cavernosa of the patient’s penis. This treatment known as fucosylation stands for adding units of fucose sugar to molecules to enhance their functionalities. It takes just 30 minutes to treat the cells with TZ101, after which they are ready to be infused into the patient’s system. No supporting procedures are required after the infusion.
Ones of the main challenges the researchers using stem cells to restore sexual function in men with prostate cancer are facing is the fact that it’s difficult to retain such cells inside the patient’s corpus cavernosum after the therapy. This is another problem that Targazyme’s new product aims to solve since fucosylation has been proven to help treated cells home effectively to the organ they are delivered to.
It should be noted that erectile dysfunction treatment is clearly not the primary field of application for TZ101. CEO of Targazyme, Lynnet Koh, sees more potential in using the company’s flagship product in patients that require hematopoietic stem cell transplantation for treatment of leukemia, lymphoma and other blood cancers. The potential of TZ101 in cancer immunotherapy is high as well. However, the fact that Targazyme has received the grant for ED treatment testing means that there are many possible applications of the product. If the results of the clinical trials are positive, they will serve as additional validation of TZ101’s effectiveness and will allow the company to proceed to further in vivo tests and expedite the approval and release of the product.
While the testing of unmodified and TZ101-treated stem cells is still in progress, post-RP patients with erectile dysfunction are usually offered to choose from two conventional treatment algorithms. The first involves the use of PDE5-inhibitors like sildenafil, vardenafil or tadalafil, either on a daily basis or as-needed to enhance penile rehabilitation after surgery. The second utilizes vacuum erection devices, or VEDs, and is beneficial for both restoring the sexual function and helping avoid penile shortening typical in post-RP patients. It should be noted that no official clinical guidelines for penile rehabilitation after radical prostatectomy exist at the moment. There are multiple studies both supporting post-RP penile rehabilitation with PDE5i medications and VEDs and claiming that it’s ineffective, but, in practice, it is commonly adopted by healthcare specialists worldwide.
- JC Emanu et al, Prevalence of erectile dysfunction in post-RP patients - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5005072/
- L Incrocci, Radiotherapy for prostate cancer and erectile dysfunction - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4708125/
- MK Haahr et al, Clinical Phase I trial of stem cell therapy for post-RP patients with erectile dysfunction - https://www.sciencedirect.com/science/article/pii/S0090429518305867
- TZ101 by Targazyme product description - https://targazyme.com/products/
- Targazyme receives funding for TZ101 study in post-RP patients with ED - https://www.accesswire.com/538277/Award-Received-from-the-Sexual-Medicine-Society-of-North-America-to-Fund-a-Targazyme-TZ101-Study-to-Reverse-Erectile-Dysfunction-in-Prostate-Cancer-Patients
- L Xia et al, Effect of surface fucosylation on engraftment of human cord blood cells into bone marrow - https://targazyme.com/wp-content/uploads/2013/12/Xia_McEver_Blood_2004.pdf
- J Clavell-Hernandez et al, Evidence for and against penile rehabilitation after radical prostatectomy - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6368034/