PolyPid Announces Positive Preclinical Data of its Intra-tumoral OncoPLEX in Brain Cancer
- Positive Results in Two Animal Models of Glioblastoma Multiform (GBM) demonstrated that Single Local Treatment of OncoPLEX Significantly Inhibited Tumor Growth and Prolonged Survival
- Company Expects a Pre-IND Meeting with the
U.S.FDA by Year End and Potential Initiation of Phase 1/2 Clinical Trial of OncoPLEX in Brain Tumors in 2022
OncoPLEX utilizes the Company’s novel PLEX technology to provide controlled local exposure to docetaxel, one of the most widely used chemotherapy agents, for a few weeks in the intra-operative tumor resection setting, to potentially reduce local tumor recurrence, tumor spreading and prolong patient survival.
The OncoPLEX intra-tumoral cancer therapy program was evaluated in brain tumors for tumor growth and survival in two Glioblastoma Multiform (GBM) animal models. Key results included:
- OncoPLEX induced strong inhibition of tumor growth and recurrence in a partially resected human glioblastoma subcutaneous mouse model. A single local OncoPLEX application induced 98% tumor growth inhibition (day 41 post operation) compared to the untreated control (p<0.001), and 66% compared to multiple injections of systemic chemotherapy treatment arm (p=0.0165). The day 41 survival rate for OncoPLEX was much higher than the systemic treated mice, or untreated with 60%, 20%, and 10% survival, respectively.
- OncoPLEX was also tested in a GBM brain rat model. OncoPLEX, applied locally next to the non-resected tumor in the brain, showed a 40% survival rate at day 23 following the beginning of treatment, as compared to a 0% survival rate in the standard systemic treatment arm (Temozolomide 33.5 mg/kg, 5 treatment days), the placebo arm (OncoPLEX without Docetaxel) and in the untreated control arm. Only OncoPLEX significantly enhanced the overall survival compared to both the placebo arm and to the untreated arm (p<0.02).
- Dose response was demonstrated for OncoPLEX in the different animal models.
- Local application of OncoPLEX in a rat brain model evidenced good safety profile at the different doses studied.
“The growing set of data from our OncoPLEX preclinical studies continue to look promising,” said Dr.
OncoPLEX is PolyPid’s lead intra-tumoral product candidate in Oncology. OncoPLEX utilizes the Company’s novel PLEX technology to provide controlled local exposure to docetaxel, one of the most widely used chemotherapy agents, directly at the tumor site for few weeks to potentially reduce local tumor reoccurrence, the potential spreading of cancer cells, and ultimately improve the overall survival rate of cancer patients. Local delivery of drugs directly into the tumor site, especially in difficult to access tumors such as in the brain, may significantly improve the clinical outcome. The OncoPLEX intra-tumoral cancer therapy program has been evaluated successfully in various animal tumor models, including colon carcinoma and glioblastoma.
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Dikla Czaczkes Akselbrad
EVP & CFO
Source: PolyPid Ltd.