SAN
FRANCISCO, March 29, 2024 /PRNewswire/ -- Biostar
Pharma, Inc., the U.S. subsidiary of Beijing Biostar
Pharmaceuticals Co., Ltd. which is a synthetic biology driven
biopharma company focusing on the development and commercialization
of innovative oncology drugs, announced today that their core
pipeline product utidelone injectable (UTD1) had been granted an
Orphan Drug Designation (ODD) by the FDA for the treatment of
breast cancer brain metastasis (BCBM).
Up to 30% of metastatic breast cancer patients
develop brain metastases (BM). Prognosis of patients with
BM is poor and long-term survival is rare. Currently the survival
duration of BCBM patients is very limited, with the median survival
of only about 7.2 months, and even shorter for triple-negative
breast cancer (TNBC) BM which is only 3.5 months. Macromolecular
drugs usually cannot penetrate the blood-brain barrier (BBB),
leading to low therapeutic efficacy. Therefore, local treatments
including surgery and radiation therapy are currently considered
the standard treatments for BCBM. As of now, there is only one drug
approved for the treatment of BCBM globally, suggesting huge unmet
medical needs [1].
Utidelone has the ability to cross BBB due to its unique
physicochemical characteristic and insusceptibility to
P-glycoprotein-mediated efflux. This ability has been well
demonstrated by both preclinical and clinical studies. A phase II
clinical trial of utidelone injectable in combination with
etoposide and bevacizumab for HER2 negative BCBM patients (n=17)
showed excellent central nervous system (CNS) overall response rate
(ORR) and CNS clinical benefit rate (CBR) of 73% and 91%,
respectively. Another phase II clinical trial of utidelone
injectable in combination with bevacizumab for HER2 negative BCBM
patients (n=46) demonstrated median PFS of 7.7 months and 12-month
OS rate of 74.4%. The FDA granted ODD to utidelone injectable for
the treatment of BCBM based on these promising data.
Considering utidelone's excellent BBB-crossing capability and
its therapeutic potential for brain tumors, Biostar Pharma also
plans to advance the clinical studies of utidelone injectable for
the treatments of other brain tumors such as lung cancer brain
metastasis and glioma this year.
About Orphan Drug
An orphan drug is used to treat a rare disease that affects
fewer than 200,000 patients in the US. Orphan drug development
presents several major challenges including difficulties in patient
recruitment, small market size and low return for the
pharmaceutical companies. To encourage drug development for the
benefit of rare disease patients, an ODD granted by the FDA
provides many incentives such as tax relief on clinical trial
costs, opportunity to apply for grants to support clinical trials,
waiver of new drug application fee, acceleration for regulatory
pathway, and the potential to receive 7 years of marketing
exclusivity in the US market upon product approval.
About Beijing Biostar Pharmaceuticals Co., Ltd.
Beijing Biostar Pharmaceuticals Co., Ltd. is an integrated
biopharma company focusing on the development of first- and
best-in-class innovative anti-cancer drugs with independent
intellectual property through state-of-the-art technology platforms
of combinatorial biosynthesis, microbial fermentation production
and microbial drug formulation development. With an insight-driven
strategy, experienced R&D teams, cGMP-compliant manufacturing
facility and domestic commercialization capability, the company
have built a balanced product pipeline, covering both lead product
life-cycle expansion and early-stage projects development. Further
information can be found on the company's website
http://www.biostar-pharm.com/en or by contacting our business
development team at bd@biostar-pharma.com on partnering with
us.
[1]
Source: Frost & Sullivan Analysis
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SOURCE Beijing Biostar Pharmaceuticals Co., Ltd.