Cytori Reports Summary of FDA Feedback Regarding its ATI-1123 Product
July 01 2019 - 8:30AM
Cytori Therapeutics, Inc. (NASDAQ: CYTX) today provided an update
on the development of its proprietary drug, ATI-1123, based on
recently obtained feedback from the United States Food and Drug
Administration (FDA). ATI-1123 is a substantially redesigned and
reformulated new drug based in part, on the active pharmaceutical
ingredient, docetaxel. ATI-1123 may have future clinical utility in
a number of difficult to treat cancers.
The purpose of the Company’s submission was to
clarify certain key aspects of the future development plan
including: (1) the suitability of the 505(b)(2) pathway for
approval of the proposed ATI-1123 drug product, including the
proposed listed drug (LD), (2) the adequacy of the referenced
clinical, nonclinical and pharmaceutical quality information, in
combination with the proposed drug development program, to support
the new drug application and (3) any concerns that the FDA may have
with regard to other filing issues specific to the product.
Key feedback from the FDA included that a
505(b)(2) application appears to be an acceptable regulatory
approach with docetaxel injection as a potentially acceptable LD.
Furthermore, the FDA agreed that the completed nonclinical studies
are sufficient to support the initiation of the clinical trial of
ATI-1123 in patients with platinum-sensitive small cell lung cancer
who have progressed at least 60 days after initiation of first-line
therapy.
“Small cell lung cancer is an aggressive
neuroendocrine malignancy characterized by high metastatic
potential and poor relative outcomes,” said Dr. Marc H. Hedrick,
M.D. “Due to the propensity of small cell lung cancer to
metastasize widely and early in the disease course, it is
considered the most lethal lung cancer subtype and new therapies
such as ATI-1123, are desperately needed for these patients.”
ATI-1123 has completed a phase I trial. Based on
the FDA feedback, the Company plans to proceed with a follow-on
phase II trial in platinum-sensitive small cell lung cancer who
have progressed at least 60 days after initiation of first-line
chemotherapy.
About Cytori
Therapeutics, Inc.
Cytori is developing, manufacturing, and
commercializing nanoparticle-delivered oncology drugs. Cytori
is focused on the liposomal encapsulation of anti-neoplastic
chemotherapy agents or other drugs which may enable the effective
delivery of the agents to target sites while reducing systemic
toxicity and improving pharmacokinetics. Cytori’s pipeline
consists of ATI-0918 pegylated liposomal doxorubicin hydrochloride
for breast cancer, ovarian cancer, multiple myeloma, and Kaposi’s
sarcoma, a complex/hybrid generic drug, and ATI-1123 patented
albumin-stabilized pegylated liposomal docetaxel for multiple solid
tumors. For more information, please
visit ir.cytori.com.
Cytori Therapeutics, Inc.
Gary Titus, +1 (858) 458.0900 ir@cytori.com
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