Clinical Research

General information about clinical research; DexTech works with so-called translational research, which means that pre-clinical innovations (candidates) are developed to be studied in clinical studies (in humans). Financial costs differ between the three study phases (fig.1), where phase 1 and phase 2, depending on the number of study centers and study protocols, cost approximately SEK ≤100M, while Phase 3, which is registration-based, costs SEK >500M. In addition, there are organizational/human resources with an increased number of participating patients and study centers (Figure 2)

Figure 1

Figure 2

Consequently, the need for study drug varies between study phases with dramatically increased need at Phase 3 (Figure 3). The consequence is that the manufacturing process must be scaled up by phase 3 at the latest.

Figure 3

The current chances of success in the step from preclinical to clinical research are relatively small, where about 90% fail to repeat results in humans (has been described as a “valley of death”, i.e. the candidate’s death, applies to the development of cancer drugs). Of the candidates who start phase 1 studies, more than 80% will fail. The most common causes are insufficient efficacy and unexpected toxicity (side effects). Of the candidates who start phase 3, about 50% will fail, usually for the same reasons as after phase 2. Only about 5% of candidates will succeed in becoming a registered drug.

*Nature. 2008; 453 (7197):840-842

*Am J Transl Res. 2014; 6(2):114-118

DexTech, clinical research

Since the late 1990s, DexTech has conducted/is conducting clinical studies mainly in the patient category castration-resistant prostate cancer (Table 1).

Table 1

¹Ann. N.Y. Acad Sci., 2004, 1028:361-374.

²Anticancer Res. 36: 6499-6504 (2016)

³European J of Cancer 181 (2023) 198e207

The studies have been published in peer-reviewed international journals.