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Subject 2014.03 Product development status
Writer ViroMed
Date 2014/03/20
The following progresses have been made in the last 2 months. In general, most projects are progressing smoothly. 

▣ Critical Limb Ischemia (CLI) Drug: On March 18th, we submitted the final report for phase II clinical study of VM202-PAD to the US FDA. We will be discussing with the US FDA regarding phase III clinical study and our goal is to acquire phase III approval within this year. On March 30th, Dr. Emerson Perin, the head PI for phase II clinical study, will be presenting the phase II clinical study results of VM202-PAD at the American College of Cardiology (ACC). 

▣ Diabetic Peripheral Neuropathy (DPN) Drug: The last follow-up of the last patient of phase II clinical study was completed on March 11th. This concluded the 9 months follow-up monitoring of all patients. Phase II clinical study of VM202-DPN was conducted at 17 hospitals in the US and Korea. Confirming efficacy was the major purpose of this study. The data analysis based on the US FDA guideline will begin soon. Patients’ data from all 17 hospitals will be collected at a CRO in the US followed by data locking >> unblinding >> statistical analysis steps. We plan to confirm the safety and efficacy results by September of this year. 

▣ Amyotrophic Lateral Sclerosis (ALS, commonly known as “Lou Gehrig’s disease”) Drug: The drug has been designated as an orphan drug by the US FDA on February 17th. On March 11th we initiated the administration of the drug to the first patient. The phase I/II clinical study of VM202-ALS will involve 18 patients and will evaluate the safety and efficacy of the drug. 

▣ Successful Completion of Human Trial & New Product Release: The human trial conducted at Ewha Womans University for HX106 showed significant improvement in attention and memory. We have applied for functional health claim based on the result. Once the application is approved by KFDA, we will release the product as functional food product first, but we also have plans to develop it as botanical medicine after additional clinical studies. Based on the results from the study we have released a new nutraceutical product with HX106 base.

Project Title

Target Indication

Country

Status

VM202-PAD

Peripheral Artery Disease

(Critical Limb Ischemia)

US/Korea

Phase II clinical study completed (submitted final report to the US FDA). Preparing to initiate meetings with the US FDA, to present the data at the ACC in the US, and to publish the data in a scientific journal.

China

Phase II in progress

(Completed administration of 162/200 patients)

VM202-DPN

Diabetic Peripheral Neuropathy

US/Korea

Phase II follow-up completed

VM202-ALS

Amyotrophic Lateral Sclerosis (Lou Gehrigs Disease)

US

Phase I/II ongoing and received orphan drug designation from the US FDA

(Initiated administration of 1/18 patients)

VM206

Breast Cancer

Korea

Phase I clinical study completed

Preparing to present data in an academic conference in the US

VM501

Chemotherapy Induced Thrombocytopenia

China

Phase III in progress

PG102

Allergic Diseases

Korea

Preparing phase III IND application

HX106

Memory & Attention Improvement

Korea

Applied for functional health claim  and launched a new nutraceutical product

PG102

Immune Hypersensitivity

Korea

Sold online and at domestic pharmacies as a dietary supplement

VM811

Joint Health

Korea