STA Pharma completes clinical supply of PhoenixMD’s breast cancer treatment

By Maggie Lynch

- Last updated on GMT

(Image: Getty/kritchanut)
(Image: Getty/kritchanut)

Related tags STA pharma WuXi STA Breast cancer Clinical trial Metastatic breast cancer HER2 Gmp

Clinical trial supply for the first targeted treatment of triple-negative breast cancer completed through PhoenixMD and STA Pharmaceutical agreement.

The drug candidate from Phoenix Molecular Designs, PMD-026, the first RSK inhibitor therapy for triple-negative breast cancer (TNBC), will enter the clinic in an upcoming Phase I/Ib study in women with breast cancer in the third quarter of 2019. The drug will also enter a toxicology study for investigational new drug (IND) application purposes.

STA Pharmaceutical, a subsidiary of WuXI STA, completed the manufacturing of the clinical supply of the drug product after the two companies entered an agreement in March 2018. STA produced a multi-kg drug supply of the candidate under good manufacturing practices (GMP) practices which is sufficient to treat all patients in the clinical trial.

The collaboration, which PhoenixMD said was a critical part of advancing the drug candidate to the clinic, will continue as WuXi STA recently expanded its operations in the US to include capsule production under GMP regulatory compliance.  

According to Sandra Dunn, CEO of PhoenixMD, metastatic TNBC, for which PMD-026 is a treatment, is the most deadly type of breast cancer. She added that PMD-026 is the first drug to ever reach clinical use against this novel target.

As a ribosomal S6 kinase (RSK) inhibitor therapy, PMD-026 works on the kinase protein that drives the growth of the breast cancer subtype relative to the hormone positive or HER-2 positive breast cancer. The company stated that the candidate is also applicable to greater than 14 different types of cancers.

Related news

Show more

Related products

show more

The Complete Guide to eRegulatory and eSource

The Complete Guide to eRegulatory and eSource

Florence Healthcare | 01-Apr-2023 | Insight Guide

Shifting to eRegulatory and eSource workflows is a requirement for clinical trial sites to continue to scale and grow their studies. This guide is designed...

Drug Solubility and the Need for Speed

Drug Solubility and the Need for Speed

Lonza Small Molecules | 28-Mar-2023 | Technical / White Paper

A growing number of new chemical entities are highly insoluble, leading to problems with bioavailability. Drug manufacturers therefore have to find ways...

Are You Prepared to Meet the New FDA Guidelines?

Are You Prepared to Meet the New FDA Guidelines?

Elligo Health Research® | 23-Mar-2023 | Insight Guide

On April 15, 2022, the U.S. Food and Drug Administration issued a new draft guidance to clinical research sponsors on creating a plan to enroll more participants...

ODM and CDASH in CRF design

ODM and CDASH in CRF design

Formedix | 10-Mar-2023 | Technical / White Paper

The lesser-known Operational Data Model (ODM) standard is often overlooked as it's not required by any regulators. So, why should you be interested...

Related suppliers

Follow us

Products

View more

Webinars