Allarity Therapeutics Provides Update on Dovitinib Program - Seite 2

Nachrichtenquelle: globenewswire
23.10.2020, 08:35  |  193   |   |   

Steve Carchedi, CEO of the Company, noted “Although we are disappointed with the unanticipated contract manufacturing delay for our priority dovitinib program, and the resulting setback of our planned first NDA filing for this promising cancer therapeutic, we recognize the delays are a result of the ongoing coronavirus pandemic that is affecting many facets of our industry. We remain fully committed to advancing the near-term filing of our first dovitinib NDA towards hopeful U.S. approval and to bringing this beneficial cancer therapeutic to RCC patients. Moreover, we are enthusiastic about remaining on track with our planned PMA filing for the Dovitinib DRP companion diagnostic this year.”   

About Allarity Therapeutics
Allarity Therapeutics (Nasdaq First North Growth Market Stockholm: ALLR.ST) develops drugs for personalized treatment of cancer guided by its proprietary drug response predictor technology, the DRP platform. The company has a mature portfolio of six drug candidates, including compounds in the pre-registration stage. The product portfolio includes: stenoparib (2X-121), a PARP inhibitor in Phase 2 for ovarian cancer; dovitinib, a pan-TKI in post-Phase 3  for renal cell carcinoma; IXEMPRA (Ixabepilone), a microtubulin inhibitor approved in the U.S. for the treatment of breast cancer;  LiPlaCis, a liposomal formulation of cisplatin in Phase 2 trials for breast and prostate cancer;  2X-111, a liposomal formulation of doxorubicin under manufacturing for Phase 2 in breast cancer; and irofulven, a DNA damaging agent in Phase 2 for prostate cancer.

About the Drug Response Predictor – DRP Companion Diagnostic

Allarity uses its drug specific DRP to select those patients who, by the genetic signature of their cancer, are found to have a high likelihood of responding to the specific drug. By screening patients before treatment, the response rate can be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and prior clinical trial outcomes. DRP is based on messenger RNA from the patient’s biopsies. DRP has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in nearly 40 clinical studies that were examined, including an ongoing, prospective Phase 2 trial. The DRP platform can be used in all cancer types and is patented for more than 70 anti-cancer drugs.

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Allarity Therapeutics Provides Update on Dovitinib Program - Seite 2 Press release       Hørsholm, Denmark (23 October 2020) – Allarity Therapeutics A/S (“Allarity” or the “Company”) today announced several updates related to its planned filing of a new drug application (NDA) with the U.S. Food and Drug …

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