Earlier this year, presented DexTech Medical the first preliminary results from its ongoing multicenter phase IIb clinical study with OsteoDexSo far, everything indicates that the substance appears to have a potentially inhibitory effect on castration-resistant prostate cancer with bone metastases (CRPC), with bone marker values normally maintained or gradually normalized where they were previously abnormal.
The recruitment status of the study at the end of April shows that approximately half of the total number of planned patients (60) have been recruited. The company's forecast that the entire year of 2017 will be needed for the study to be fully recruited remains unchanged. DexTech's goal is to out-license OsteoDex no later than after the completion of the Phase II study.
The medical need is great – existing drugs for the disease have in common that they gradually lose their effectiveness, as patients inevitably develop resistance to the treatment after a period of medication. OsteoDex could therefore be an important addition to the arsenal of weapons to combat CRPC, which is unfortunately incurable and is usually listed as the second most common cause of cancer death among men, after lung cancer.
Positive effect persists and has been strengthened in some patients
The multicenter clinical study with OsteoDex is being conducted at three clinics in Sweden (Norrlands University Hospital in Umeå, Södersjukhuset in Stockholm and Örebro University Hospital), as well as at international clinics in Finland (Tampere University Hospital), Estonia (East Tallin Central Hospital and Tartu University Hospital) and Latvia (Riga East University Hospital and Daugavpils Regional Hospital). Every two months, samples are sent to Karolinska Hospital's clinical chemistry laboratory for analysis of substances that reflect the activity in the patients' skeletal metastases, so-called "key analytes".
The most recently published study results show that the trend persists or is strengthening among the majority of the treated patients in the study.
No serious side effects of the treatment
An independent data monitoring committee (DMC) has evaluated and assessed the safety of the study as good and a decision has been made that the study can continue and that randomization to the highest dose group can begin. The fact that no side effects have been seen is very important as patients in this vulnerable group are often already weakened and sensitive to additional stress.
»The new results, now from more patients, strengthen the positive trend we previously noted. The safety of the treatment, i.e. the absence of serious side effects, feels reassuring.« – Anders R Holmberg, CEO of DexTech Medical
DexTech Medical's primary drug candidate
OsteoDex is a substance with dual functions that partly counteract bone breakdown, partly act as a cytotoxic agent that kills cancer cells. The treatment is "targeted", i.e. the substance is concentrated in the bone precisely where the metastases are located and has an active disease-inhibiting effect, which means that it has the potential to prolong survival in cancer patients. During the clinical phase I/IIa study that has previously been conducted with positive results, a strong effect on the above-mentioned bone markers in the patients was seen in the highest dose group where the effect was also studied, which is a clear indication that OsteoDex at the appropriate dose has the expected effect.
Similar mechanism of action in three of the most common forms of cancer
In extended preclinical studies, OsteoDex, in addition to a potent tumor cell killing effect in prostate cancer, also shown a similar effect at breast cancer as well as the most common form of lung cancer; non-small cell lung cancerThe mechanism of action of the drug candidate appears to work similarly on these difficult and, like prostate cancer, very common forms of cancer.
Market potential
The commercial potential in prostate cancer is great. On the top 20 list of the best-selling cancer drugs in 2014, no less than three targeted prostate cancer; Zytiga, Xtandi and Zoladexand Xgeva which specifically targets bone metastases. Together, these drugs reached over a staggering SEK 50 billion in annual sales.
The large market potential means that there is great interest in the indication among the world's pharmaceutical giants. This has also resulted in a number of spectacular corporate deals in recent years, one of which has an interesting connection to DexTech Medical, Algae (see link to article below).
About prostate cancer
The number of diagnosed prostate cancer cases has increased sharply over the past 35 years, and in Sweden alone, approximately 10 new cases are detected annually, of which approximately a quarter of those affected die. Approximately 000 million men are estimated to suffer from prostate cancer in the seven largest pharmaceutical markets: the United States, the United Kingdom, Germany, France, Italy, Spain and Japan. In the United States, approximately 1,75 new cases were estimated in 220, and prostate cancer is listed as the second most common cause of cancer death – only lung cancer kills more American men.
Read also: “There are clear parallels between DexTech Medical and Algeta”
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