Novogen Limited NVGN announced results from a comprehensive scientific review of its research and development programs.
The comprehensive scientific review was conducted under the guidance of the company’s acting Chief Executive Officer (CEO), Iain Ross. The company expects to appoint its permanent CEO by year-end.
Novogen has two drug technology platforms – superbenzopyran (SBP) and anti-tropomyosins (ATMs). While the company is developing Cantrixil and Trilexium based on the SBP platform, Anisina is being developed using the ATM platform. Novogen intends to commence phase I studies on Cantrixil (late-stage ovarian cancer in patients who may or may not have associated malignant ascites) and Anisina (neuroblastoma) in Australia in 2016 and Trilexium (diffuse intrinsic pontine glioma (DIPG)) by 2017. Both Anisina and Cantrixil enjoy orphan drug designation for neuroblastoma and ovarian cancer, respectively. We remind investors that the company is also planning to advance Anisina to clinical development in the U.S. in 2016, depending on the outcome of a toxicology program on the candidate and discussions with the FDA.
In this context, we note that United Therapeutics Corporation’s UTHR Unituxin was the first drug to gain FDA approval (in Mar 2015) for use in combination with granulocyte-macrophage colony-stimulating factor, interleukin-2 and 13-cis-retinoic acid for the treatment of pediatric high-risk neuroblastoma in patients who showed at least a partial response to prior first-line multi-agent, multimodality therapy. However, Unituxin’s approval came with a boxed warning stating that the drug can cause severe life-threatening infusion reactions. The company will be required to conduct certain post-marketing studies on the drug.
Meanwhile, Novogen intends to continue evaluating Anisina for the treatment of cancer in adults. The company believes that this will further pave the way for a pediatric neuroblastoma program on the candidate. Additionally, Novogen is planning to seek orphan drug status for Trilexium in the U.S.
In addition, Novogen decided to seek patent protection for its degenerative disease and regenerative medicine program, Jacob’s Hope. However, with the company focused on near-term core opportunities (oncology), developmental activities for the Jacob’s Hope program is expected to take a back seat at present.
Given that Novogen is in early stage of development, a detailed review of its research and development programs should help to sort its priorities and ensure efficient utilization of its limited resources for achievement of its goals.
Novogen carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Valeant Pharmaceuticals International, Inc. VRX and Alcobra Ltd. ADHD. While Valeant carries a Zacks Rank #1 (Strong Buy), Alcobra holds a Zacks Rank #2 (Buy).
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