|Healthcare Review: Advaxis, Novogen, Biocryst Pharmaceuticals, Intermune, Inovio Pharmaceuticals|
|By Staff and Wire Reports|
|Tuesday, 27 May 2014 12:37|
The FDA designates Advaxis' ($ADXS) ADXS-cHER2 an Orphan Drug for the treatment of osteosarcoma. The drug is an immunotherapy that targets the HER2 receptor which is over expressed in certain cancers. The company plans to initiate a clinical development program in pediatric osteosarcoma, a rare cancer affecting ~400 children and teens in the U.S. each year.
Shares of pico cap Novogen ($NVGN) are up 5% on modest volume in response to its announcement that it has identified a number of super-benzopyran (SBP) compounds with anti-cancer activity against human prostate cancer cells in vitro. Retail investors need to exercise caution here because there is a colossal amount of time, money and effort ahead if the company intends to seek regulatory clearance for any of these product candidates. Novogen's market cap is only $24M and it is thinly traded (34K/day). Another red flag is the involvement of SA Contributor Biotech Breakthroughs. His promotion of Atossa Genetics (ATOS) ~1 year ago provides informative background info.
In a 24-patient Phase 2a OPuS-1 clinical trial, Biocryst Pharmaceuticals ($BCRX) hereditary angioedema drug BCX4161 achieves its primary endpoint of a statistically significant reduction in mean angioedema attacks versus placebo. The mean attack rate was 0.82 for BCX4161 compared to 1.27 for the control group.
It had to complete another Phase 3 trial, but Intermune ($ITMN) finally resubmits its NDA for pirfenidone. The FDA sent the company a CRL in May 2010 requiring an additional study to support the drug's efficacy in idiopathic pulmonary fibrosis (IPF).
VGX Animal Health, 90% owned by Inovio Pharmaceuticals ($INO), sells its animal health assets to Seoul-based Plumbine Life Sciences (PLS). Included in the sale is an exclusive license with Inovio for animal applications of its growth-releasing hormone (GHRH) technology and animal DNA vaccines and a non-exclusive license to INO electroporation delivery systems. VGX receives $2M cash in multiple payments, a 20% stake in PLS plus milestone payments and royalties on product sales.