Rxi Pharmaceuticals (NASDAQ:RXII)
On May 3, 2016 Rxi Pharmaceuticals announced that it had entered into a license agreement with Thera NeuroPharma for the treatment of ALS or Lou Gherig’s Disease. ALS stands for amyotrophic lateral sclerosis, and is a debilitating disease where nerves in the muscles breakdown reducing/eliminating movement. Rxi entered the agreement with this private company to potentially improve the lives of these patients with no current treatment options.
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Both Rxi and TheraNeuroPharma will use each others technology to find a new treatment option for these patients with ALS. Rxi will provide its mix RNA and RNAi hybrid technology sd-rxRNA together with Thera’s small-molecule regenerative therapeutics platform. This deal is good for Rxi because TheraNeuroPharma will be responsible for all costs of the development, commercialization, manufacturing, and regulatory costs of the trial.
Both technologies will attempt to restore motor neurons in patients which become lost with the ALS disease. Current treatment for ALS is Rilutek, which slows down the progression of the disease but does not improve it. If both technologies achieve the goal of restoring motor neurons in the body, then they may significantly help restore muscles function in patients with ALS. There are around 20,000 people diagnosed with ALS, and currently is a huge unmet medical need.
Clovis Oncology (NASDAQ:CLVS)
On May 5 Clovis Oncology announced that it would halt all clinical trials involving the use of its lung cancer drug rociletinib. In addition, the company announced that it would also reduce 35% of its workforce, because it is expecting the FDA to issue a notice that it will probably be rejecting the company’s application for FDA approval. About a month ago the drug rociletinib was scrutinized at a panel healing where members were no impressed enough with the drug to vote for accelerated approval.
The FDA advisory panel voted 12 to 1 against approval for rociletinib in the treatment for EGFR lung cancer. Now one month later the company has been cutting back, and it expects to halt the trial, known as TIGER-3, which would have ran all the way to 2018 had it been completed. To make matters worse Clovis even announced that it would pull out on its European Application for rociletinib in the Eurozone.
Accelerated approval would have allowed Clovis to sell rociletnib earlier on the market than expected. It would have been able to do so without the completion of the phase 3 trial, TIGER-3. Unfortunately the data was mixed, and it could not prove that its drug was superior to Astrazeneca (NYSE:AZN) Tagrisso. AstraZeneca had received FDA approval for Tagrisso to treat the same EFGR lung cancer patient population. This was a roadblock for Clovis, because to obtain accelerated approval a company must prove that its drug is superior to those that are already approved by the FDA.
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All this is bad news for the rociletinib program, but the good news is that the company still boasts a pretty decent pipeline. The company is now focusing all efforts on an ovarian cancer drug rucaparib. Whether this drug will be successful or not remains to be seen, but the future of the company now hinges on this program. Once again Clovis is wanting to submit this drug on a rolling NDA submission which means that it will seek accelerated approval for this drug as well. As long as the data and safety support this NDA, the company may be able to recover.
Disclosure: Author is Long Rxi Pharmaceuticals (NASDAQ:RXII)
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