TAIPEI, Taiwan and SAN DIEGO, CA, USA I Augsut 25, 2021 I Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focused on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, today announced the initiation of Dose Escalation within the Phase I Investigator Initiated Trial (IIT) of Pidnarulex for the treatment of advanced hematological malignancies. After evidence of human efficacy was observed in patients with specific biomarkers and resistant to standard treatments, including chemotherapeutics, the Phase I study was redesigned to further determine the Recommended Phase II Dose.
This open-label dose escalation Phase I IIT study of Pidnarulex is sponsored by the Peter MacCallum Cancer Center (PMCC), in Australia, focusing on various haem cancers, including multiple myeloma, T-cell non-Hodgkin lymphoma, acute myeloid leukaemia and myelodysplastic syndrome. Senhwa is providing the study supplies and the Investigational Product, Pidnarulex, which is intravenously administered on 4-week cycles.
The preliminary results from the preceding portion of the Phase I study, completed in 2017, demonstrated that among the 16 evaluable patients, one patient experienced a partial response after the Pidnarulex treatment, while five patients had stable disease. The PMCC was invited to the 59th American Society of Hematology annual meeting on 11th December, 2017, and presented a poster on these findings.
"The multiple myeloma patients enrolled in the initial portion of the Phase I study were resistant to other therapies; however, fifty percent of the multiple myeloma patients treated with Pidnarulex were able to stabilize their conditions. We here at Senhwa will continue to work at providing alternative therapeutics for treatment resistant cancers," said Dr. John Soong, Chief Medical Officer of Senhwa Biosciences.
"We look forward to the outcome of this study and we hope that the findings may inspire more collaborative opportunities to determine if Pidnarulex is effective in treating various forms of haem cancers," said Tai-Sen Soong, the Chief Executive Officer of Senhwa Biosciences.
Hematological cancers affect populations worldwide, notably, there are more than 160,000 new cases of multiple myeloma worldwide per year. The global drug market for multiple myeloma is expected to reach USD 37.5 billion by 2024, according to the forecast of Grand View Research, a leading market research firm.