AUSTIN, Texas January 15, 2018
HCell Inc. (Hcell), a biotechnology company based in Austin, Texas, focusing on Alopecia Areata in the Pediatric Population, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to HC017AA for the treatment of pediatric patients with Alopecia Areata, a devastating hair loss disease.
“The granting of Orphan Drug Designation by the U.S. FDA is a significant milestone for HCell in the HC017AA development program,” said Jae Hyun Lim M.D., Ph.D, Co-Founder and Chief Science Officer at HCell Inc. “We are working diligently to prepare for the clinical study for this significant, yet unmet, medical need for Alopecia Areata in pediatric patients.”
The FDA grants Orphan Drug Designation status to drugs and biologics that treat rare diseases, which is defined as those affecting fewer than 200,000 people in the United States. The FDA Office of Orphan Products Development evaluates scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases and to advance scientific development of such promising medical products. Orphan Drug Designation allows HCell Inc. to be eligible for a seven-year period of U.S. marketing exclusivity upon approval of HC017AA, including tax credits for qualified clinical research costs, and a waiver of the Prescription Drug User Fee Act (PDUFA) filing fees, subject to certain conditions.
“ODD Status from the FDA’s recognition gives HCell Inc. a number of potential financial benefits and is aligned with our ongoing work seeking expedited pathways towards product approval in the United States,” Dr. Lim added.
HC017AA is currently in development for non- surgical treatment for Alopecia Areata in Pediatric Patients. HC017AA is being developed into topical Injection by regenerating hair through a proprietary blend of commercially procured biologic and autologous tissue. HCell Inc. is planning to initiate human clinical study in the U.S.
About Alopecia Areata
Alopecia (Hair loss) refers to a change such as the absence of hair or the thinning of hair. Hair loss diseases are manifested in various forms, and there are various kinds, such as Alopecia Areata, which effects people of all ages, gender and ethnic groups. Alopecia Areata is known as an autoimmune skin disease which occurs when the immune system attacks the hair follicles in error, causing hair loss in patches. Alopecia Areata often develops suddenly, over the course of a couple of days. Alopecia Areata often starts from a hair loss in coin size which can lead to general hair loss of all body or 50% of the scalp (through thinning or total loss of hair) as progression may continue and conditions may worsen and recover repeatedly.
Alopecia Areata is gradually increasing amongst all ages, genders and ethnic groups. There are currently no FDA approved treatments for Alopecia Areata and there is no known cure for this condition, yet.
About HCell Inc.
HCell Inc. is a privately held biotechnology company, based in Austin, Texas, devoted to research, developing advancement treatment for patients with various forms of alopecia regardless of gender, age or ethnicity. HCell is currently focusing on HC017AA for the treatment of Alopecia Areata in pediatric patients.
HCell Inc. is also working on initiating regulatory steps for HC0100, which comprises proprietary composition and procedure for the treatment of Androgenic Alopecia conditions in both men and women. Furthermore, HCell Inc. is planning pre-clinical development with the intent to launch a human clinical study in the United States. For more information, please visit http://www.hcell.net.
This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding the anticipated timing for HCell Inc.’s filing of an IND, prospects for the development and potential efficacy of HC017AA, and the benefits of receiving the Orphan Drug Designation. In some cases, use of terms such as ‘anticipating’, ‘potential’, ‘initiating’, ‘expects, ‘plans’, ‘compelling’, ‘launch’, ‘may’, ‘could’ or other words the convey dramatic or future outcomes are all based on HCell Inc.’s current assumptions and expectations. Forward- looking statements include statements with respect to our concerns, research, development, beliefs, among other thing and are subjected to risks, inherent uncertainties, altering or changes in conditions. The timing and our ability to obtain U.S. Food and Drug Administration or other regulatory authority approval is dependent on research, developing advancing treatment to our product candidates, which does not effect our historical fact nor guarantee of future performance. Forward looking statements in this press release may differ as set forth in HCell documents and only speak solely for this press release.
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