On November 23, 2020 Hillstream BioPharma, Inc. ("Hillstream") reported that the FDA granted both the Rare Pediatric Disease Designation (RPD) and Orphan Drug Designation (ODD) to HSB-888 for Osteosarcoma (Press release, Hillstream Biosciences, NOV 23, 2020, View Source [SID1234628149]). Hillstream continues to build an attractive oncology pipeline and expands this oncology pipeline for devastating diseases with this significant milestone achievement for HSB-888. If HSB-888 gains FDA approval by 2023, Hillstream will be given a transferable Priority Review Voucher (PRV) which can be sold to further fund HSB-888 and R&D pipeline.
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Osteosarcoma has been primarily treated with the same frontline chemotherapy for three decades, called MAP, which includes methotrexate, doxorubicin, and cisplatin. The high toxicity of the MAP regimen results in cumulative toxicity which prevents continued use especially in recurrence. HSB-888 could be more efficacious, safer, and a more tolerable therapy which may improve response rates, overall survival, and quality of life. Hillstream is rapidly progressing towards a rapid IND filing process and plans to initiate a clinical trial in pediatric osteosarcoma.
"This acquisition significantly expands our oncology business with a late stage product and diversifies our oncology portfolio" stated Randy Milby, founder and chief executive officer of Hillstream. "The Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of osteosarcoma highlights the significant need for patients with this devastating disease. With the clinical data currently available, we anticipate a rapid progression toward an IND and initiation of Phase 1b/2a trials. We look forward to sharing our progress about these and future milestones with current and potential shareholders."
In addition, Hillstream continues progressing its pre-clinical pipeline of assets, including HSB-1216 for the treatment of small cell lung cancer. HBS-1216 is a potent cancer stem cell inhibitor. This combined portfolio enables Hillstream to have additional capability to address unmet needs in multiple, high, unmet-need orphan tumors.
About Pediatric Osteosarcoma
Osteosarcoma remains the most common primary pediatric bone malignancy mostly occurring in adolescents for which treatment has remained essentially unchanged for more than three decades. Osteosarcoma is a highly aggressive tumor with metastatic disease either at diagnosis or at the time of recurrence portending a poor prognosis with five-year survival rate survival below 30%. Osteosarcoma is found in about one thousand people with about half diagnosed in adolescents in the United States each year, most often during the growth spurt of the teen years.
About Rare Pediatric Disease Designation and Orphan Drug Designation
The U.S. Food and Drug Administration (FDA) Office of Orphan Products Development granted Orphan Drug Designation (ODD) to HSB-888 for the treatment of pediatric osteosarcoma, a rare pediatric cancer. The FDA grants ODD to therapies targeting conditions that affect fewer than 200,000 people in the U.S. The designation provides seven-year market exclusivity, increased engagement, and assistance from the FDA, tax credits for certain research, research grants, and a waiver of the New Drug Application user fee. HSB-888 also has Rare Pediatric Disease Designation for osteosarcoma. The FDA grants Rare Pediatric Disease Designation for serious and life-threatening diseases that primarily affect children ages 18 years or younger and fewer than 200,000 people in the U.S. If Hillstream’s new drug application for osteosarcoma is approved, Hillstream may receive a priority review voucher from the FDA, which can be redeemed to obtain priority review for any subsequent marketing application or may be sold to another company for their programs.