Summary: a multi-herb product with previous human experience data and lab tests showing effect in elevating white cell count. The Sponsor filed a pre-IND application to the US FDA under the botanical drug category. In the written response to the Sponsor, the FDA recognized the product in category of botanical drug but FDA voiced concerns about qualification of some labs that conducted the testing. FDA listed specific data requirement for phase 1 IND filing. The Sponsor is seeking partnership to co-develop this product by sharing product equity.
* American Botanical Drug Corporation is the commercial operation arm of ABDA
Composite A multi-herb product, 100% owned by a US manufacture
Formulation Softgel capsule, 2 times / day, and 2 capsules each time
Mechanism Increase white cell counts through enhancing immune system
Potential Indications
autoimmune diseases
certain cancers
History Dietary supplement marketed in the US and in China since 2018. Great safety profile and promossing efficacy data and empirical experience
Current Status
The sponsor 100% financed the the pre-clinical data generation, and the FDA botanical drug investigational new drug (IND) pre-meeting packet development and submission. FDA has responded the request. The product is allowed to proceed to the IND but additional information/data are required in the Phase 1 IND package.
Purpose Offering product equity to exchange for investment for phase 1 IND data generation and clinical trial
Selected Data
Excellent Toxicology Profile of Repeat Dose
Table 8-10 The Effect of Repeat-Dose on Weight of Rats
Table 8-11 The Effect of Repeat-Dose on Organ Pathological Changes
Table 8-12 The Effect of Repeat-Dose on Hematology
Table 8-13 The Effect of Repeat-Dose on Biochemical Index
Table 8-14 Ames Test Results
Table 8-15 Micronucleus test results on mouse bone marrow polychromatic erythrocytes
Table 8-16 Analysis of chromosome aberrations in primary spermatocytes of mouse testes
Potentials
Improving immune system is a “mechanism of action” with profound potential to treat many diseases
Selected possible indications based on “improving immune system” are:
Cancer patients undergoing chemotherapy and radiation therapy
Infections caused by bacteria and/or virus
Other immune deficiency diseases
Product# 101