Pre-clinical Data

Safety
Animal studies were performed to determine the Maximum Tolerated Dose (MTD) of neuPaclitaxel. The MTD for neuPaclitaxel administered to nude mice is 44 mg/kg. This study confirms that the neuNanoParticle^® formulation provides improved safety and tolerability relative to cremaphor-ethanol formulation.

Efficacy
The efficacy of neuPaclitaxel has been evaluated using the human breast cancer and cremaphor-ethanol formulation resistant human colon cancer xenograft mouse models. The results from these dosing regimens demonstrate significant advantages in primary end point and survivability versus cremaphor-ethanol formulation.

Human Breast Cancer (MX-1) xenograft mouse model
Dosing schedule: Q2Dx4 (IV), 22 mg/kg

Observation	Cremaphor-Ethanol Formulation 22 mg/kg (MTD)	neuPaclitaxel 22 mg/kg (1/2 MTD)
Complete tumor regression	10/10	10/10
Tumor-free survivors*	6/10	10/10
Tumor recurrence	4/10	0/10
Days of tumor recurrence	23	>120
TGD (%)	60	100

*At the end of the study (Day 121).

Paclitaxel resistant-Human Colon Cancer (HCT-15) xenograft mouse model
Dosing schedule: Q2Dx4 (IV) at MTD

Observation	Cremaphor-Ethanol Formulation	neuPaclitaxel
Survivors**	0/10	10/10
Tumor recurrence	N/A	21
TGD (%)	–	62

**At the end of the study (Day 33).


 

neuDocetaxel Program

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neuPaclitaxel Program

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neuPropofol Program