Company: APM
Filing Date: 2025-10-06
Form Type: S-4
Source: 0001213900-25-096656
Chunk: 252

Company: Aptorum Group Ltd
Filing Date: 2025-10-06
Form: S-4
Chunk 252
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 4 Figure 4: synergism between SACT -1and traditional chemotherapy in vitro 129 In addition, in our study, the maximum tolerable dose of SACT -1in a rodent model was determined to be higher than 400mg/kg. Compared with the MTD of standard chemotherapy such as paclitaxel (20 -30mg/kg) (Clin Cancer Res. 5(11):3632 -8) and cisplatin (6mg/kg) (BMC Cancer 17: 684 (2017)). Based on our internal observations of pre -existinginformation from approved products, (subject to FDA’s approval and on a case -by-casebasis, a 505(b)(2) Application can rely in part on existing information from approved products (such as the FDA’s previous findings on safety and efficacy) or products in literature (such as data available). However, typically speaking, the applicant is nonetheless required to carry out a Phase 1 bridging study to compare the Reference Drug and reference the established safety and efficacy information. At 150mg/day, the death rate was 0% in prior clinical studies of the Reference Drug with no dosage related adverse events (Table 1). In addition, the pharmacokinetic profile of the approved product (i.e.,Reference Drug) has also been reported (Table 2). Table 1: Safety Profiles of the Reference Drug in Human Clinical Trials Table 2: The pharmacokinetic Profile of the Reference Drug in Humans Positive data from our latest internal in vivostudies show significant activity against neuroblastoma tumor reduction when treated with the compound SACT -1in combination with standard of care (SOC) chemotherapy.We have developed a pediatric formulation (SACT -1) to better address the needs of neuroblastoma patients who are exclusively children younger than 5. In the Phase 1 study where SACT -1was compared to Reference drug in healthy volunteers, no serious adverse events (SAEs) were reported. All reported adverse events were Grade 1 (“mild”) with an outcome of “resolved”. No subjects were discontinued from the study due to adverse events. The safety data of the Reference Drug and the Phase 1 data of SACT -1will be included in the IND submission for the Phase 2 trials, when we are able to submit same. Separately, we also screened SACT -1for its in vitroactivity against over 300 cancer cell lines and showed positive results in a number of cancer types including in particular colore