{"id":1891,"date":"2024-03-25T12:25:45","date_gmt":"2024-03-25T11:25:45","guid":{"rendered":"https:\/\/dextechmedical.com\/?page_id=1891"},"modified":"2024-03-25T12:25:45","modified_gmt":"2024-03-25T11:25:45","slug":"clinical-research","status":"publish","type":"page","link":"https:\/\/dextechmedical.com\/en\/clinical-research\/","title":{"rendered":"Clinical Research"},"content":{"rendered":"

General information about clinical research<\/strong>; 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 \u2264100M, 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)<\/p>\n

Figure 1<\/strong><\/p>\n

\"\"<\/a><\/p>\n

Figure 2<\/strong><\/p>\n

\"\"<\/a><\/p>\n

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.<\/p>\n

Figure 3<\/strong><\/p>\n

\"\"<\/a><\/p>\n

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.<\/p>\n

*Nature. 2008; 453 (7197):840-842<\/em><\/p>\n

*Am J Transl Res. 2014; 6(2):114-118<\/em><\/p>\n

DexTech, clinical research<\/strong><\/p>\n

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

Table 1<\/strong><\/p>\n\n\n\n\n\n\n\n\n
Study<\/strong><\/td>\nPhase<\/strong><\/td>\nPatients<\/strong><\/td>\nYear<\/strong><\/td>\nCountry<\/strong><\/td>\n<\/tr>\n
SomaDex1<\/td>\n1a<\/td>\nmCRPC<\/td>\n2003<\/td>\nFinland<\/td>\n<\/tr>\n
SomaDex<\/td>\npilot<\/td>\nmCRPC<\/td>\n2008<\/td>\nMexico<\/td>\n<\/tr>\n
ODX2<\/td>\n1a<\/td>\nmCRPC<\/td>\n2013<\/td>\nSweden<\/td>\n<\/tr>\n
ODX3<\/td>\n2b<\/td>\nmCRPC<\/td>\n2020<\/td>\nSweden\/Estonia<\/p>\n

Latvia<\/td>\n<\/tr>\n

ODX<\/td>\n1a<\/td>\nMultiple<\/p>\n

myeloma<\/td>\n

2023<\/td>\nSweden<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n

1<\/sup><\/em>Ann. N.Y. Acad Sci., 2004, 1028:361-374.<\/em><\/p>\n

2<\/sup><\/em>Anticancer Res. 36: 6499-6504 (2016) <\/em><\/p>\n

3<\/sup><\/em>European J of Cancer 181 (2023) 198e207 <\/em><\/p>\n

The studies have been published in peer-reviewed international journals.<\/p>\n","protected":false},"excerpt":{"rendered":"

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). 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