The clinical study

SpectraCure follows a strict protocol and the patients who meet the requisites for the study are selected by responsible physicians at the respective clinics participating in the study.

 

Responsible physicians in the study have then performed a so called pre-screening to identify patients who fit into the study’s inclusion criteria.

The road to market

We are currently conducting a clinical phase-2 study at Princess Margaret Cancer Center in Toronto, Canada and at University College London Hospital in London, England, which is planned to be extended to further hospitals. After the initial phase-1 and phase-2 studies, there is yet another, somewhat larger, study in phase-3 before the authorities can submit market approval for this technology. The intention is to find a collaborative partner for phase-3 and in case of a successful phase-2 study proceed with a so called regulatory fast track. We plan to launch the technology first in North America and the EU. For additional, and continuously updated information, please keep an eye on our PRESS section of this site. There you will find all our press releases, newsletters, current events, etc.

Some diseases affect a relativly small number of patients in a population. To support development of treatments of these patients the authorities in the USA and EU can approve “orphan drug status”, for treatment methods that focuses on against these diseases. In the EU the criteria for the disease in question should affect at least 5 out of 10 000 people, and in the USA the criteria is tht the disease is affecting at the most 200 000 people. Even if prostate cancer is a common disease, the patient group with a relapse of the disease is relativly small, and fall under aformentioned criteria. If the treatment is approved orphan drug status in advance of an aproval, less extensive clinical trials are required than if not. This means substantially lower costs.

SpectraCures technology is protected by several patents, covering the medical technology equipment, software for dosage control, IDOSE®, and also single usage items. In total SpectraCure owns 12 approved patents. Several patent are approved in the contries that represents the largest and most important international markets: Europe, USA, Canada, Japan & China.

SpectraCures technology

SpectraCures interstitial PDT-system for Photodynamic treatment is a medicinal laser equipment that is used to activate a light sensitive drug that is injected into the patient. It is not the laser light in itself that gives the effect but the combination with the drug. Each on its own the laser and the drug are harmless and without effect.

Aside from the laser unit, the system contains technology for treatment planning and calculation of the optimal light dosage. During the laser light delivery, IDOSE® is also capable of, in real time, perform corrections of the planned dosage to ensure that the complete tumor is treated without damaging nearby organs.

The treatment planning, dosage calculations and the function to in real time adjust the dosage during the treatment is what makes the system unique. We are not aware of any company that works with directly comparable technology.

For more information about SpectraCures system with IDOSE®, read more in our Technology page on our site.

We have set as a goal that the clinical trials should highlight that our method has higher precision than other forms of treatment and because of this does not affect sensitive tissue, such as nerves, around the prostate. This means less complications. The high accuracy is achieved thanks to the fact that we can control the laser dosage with very high precision.

Investment questions

This means that SpectraCure’s stocks are traded on a stock market, in our case Nasdaq, and can be purchased and sold by the public. We also have an obligation to inform the market about news and events within the company.

SpectraCure asses that the companys criteria for investment deduction is fulfilled, but it is up to the respective investor to ensure that the requirments on their side is met for an investment deduction shall be received. For more information see this document.