Wyeth announces phase II study data

Wyeth’s Pharmaceuticals division has announced data from a phase II study of neratinib (HKI-272).

Data from tests on women with advanced HER-2-positive breast cancer, data suggested the therapy has antitumour activity.

The drug is an investigational orally-administered potent and irreversible dual inhibitor of the HER-2 and EGFR kinases.

Harold Burnsteirn, lead study investigator at Dana-Farber Cancer Institute, said: “Neratinib demonstrated activity against trastuzumab-resistant and trastuzumab-naive HER-2-positive breast cancer.

“These results warrant ongoing study to see whether neratinib will fit into our armamentarium of anti-HER2 drugs.”

Involving 136 women, the phase II study evaluated the safety and efficacy of a daily 240 mg oral dose of the drug, with the primary end point being the 16-week progression-free survival rate.

Gary Stiles, chief medical officer at Wyeth, added the data provides “important insight” into “potential clinical utility” of neratinib in HER2-positive breast cancer.

Last week, the company submitted a European Marketing Authorisation Application for its 13-valent pneumococcal conjugate vaccine.

The jab – for children aged between two months and five years old – includes the 13 most prevalent pneumococcal serotypes associated with pneumococcal disease.

Founded in 1926, Wyeth is headquartered in Madison, US and operates in more than 100 countries.