More change ahead for Novogen as interim CEO Ross orders wide review of programs

Acting Novogen CEO Iain Ross

Moving quickly to show investors a change of direction is ahead, Novogen ($NVGN) acting Chief Executive Iain Ross announced a company-wide review of its preclinical programs less than a week after the abrupt departure of his predecessor, Graham Kelly.

The biotech, listed on the Nasdaq and Australian Stock Exchange, said in a July 30 release that the review will cover targeted indications, patient administration, product formulations, manufacturing and regulatory requirement issues across technology platforms to Phase I clinical trials as soon as practicable with an eye on value.

"We remain committed to exploiting and creating value from all our technology platforms in order to build a sustainable, international, biotech company," Ross said in the release, adding, "whilst we do not rule out securing third party collaborations and partnerships to further validate and fund our programs, I can confirm there are no M&A plans."

However, Ross said the scope of the biotech's programs means that some hard choices need to be made.

"Notwithstanding, it is clear that we cannot realistically undertake and fully resource all our research and development programs in parallel all the way through to market approval and launch."

On June 24, Kelly said that "with $45M in cash, and the very real prospect of another $33M by the end of the year via short-term warrants, our shareholders have given the company the opportunity it asked for to prove the merit of its two technology platforms" with chemotherapy drug Anisina set to enter the clinic in 2016.

Former Novogen CEO Graham Kelly

Kelly's departure this week came as the company presented details in July for a promising in vivo proof-of-concept study for anti-tropomyosin drug candidate Anisina in the U.S.

On the company's website was an update on Anisina with a presentation by Timothy Cripe, a doctor with the Nationwide Children's Hospital Research Institute, at the 8th Annual Cancer Molecular Therapeutics Research Association meeting in Boston.

It showed improved efficacy of vincristine in animals and suggested the potential to increase the effectiveness of chemotherapy for children with fewer side effects.

The animal study, CHLA-20, to evaluate Anisina either alone or in combination with vincristine in a mouse model of human neuroblastoma was part of Australia's Children's Oncology Drug Alliance.

Ross, in the release, also said the company was searching "for a world class CEO and authorized the immediate recruitment of additional staff including a full time CMO, project, and manufacturing management support."

The company did provide detailed general updates on its programs but strongly suggested the priority list would change.

"Whilst not wanting to pre-empt the outcome of the review I anticipate we may have to re-prioritize some of the programs," Ross said.

- here's the Novogen release