Rxi Pharmaceuticals (NASDAQ:RXII)
On Monday December 21, 2015 Rxi Pharmaceuticals announced that it had started its phase 2 trial with its Samcyprone drug to treat patients with Warts. The phase 2 trial is named as RXI-SCP-1502 and will treat patient’s Warts using the Samcyprone gel. Samycprone was acquired by Rxi from Hapten Pharmaceuticals, and now Rxi will be responsible for carrying out the clinical trials for the drug to become FDA approved.
Samcyprone has been used fro many years as a mix in pharmacies, but has never been approved as a drug by the FDA. Rxi is hoping to change that, and this is one of the three phase 2 trials it has started with. That is because Samcyprone has also shown to work in patients with Alopecia Areata — hair loss — and metastatic melanoma — skin cancer. In preliminary phase 2a trials Samcyprone in Alopecia Areata achieved 67% to 78% response rates. In Metastatic Melanoma Samcyprone achieved 40% complete clearance rates, and 38% partial clearance rates.
In early phase 2a trials for Warts Samcyprone achieved 80% to 85% clearance rates. This is a pretty good percentage of clearance, and the fact that Samcyprone is a gel type drug, thus patients avoiding having to take oral pills, perform small surgeries, or other harsh measures. The patients that will be recruited in this trial will be those who have had their warts for at a minimum of 4 weeks or more.
Before the patients fully begin to be treated with their Warts, their will be an initial skin reaction phase. The reason for this phase is to determine if the skin reacts negatively to the gel. Therefore patients will have another portion of their skin treated, non wart lesion, and then followed for one week. If all goes well in the initial stage then the patients will move on to the treatment stage where Samcyprone will be put on their Warts. This final part of the stage will last for 10-weeks where patients will be monitored for clearance.
Investigators will monitor the wart clearance with The Investigators Global Assessment Score — IGAS — and other Wart measurement tools. Samcyprone is a good addition for Rxi because it adds another phase 2 asset to the pipeline besides RXI-109. In addition, Samcyprone is a dermatological product so it is a good fit for the company. Rxi’s other phase 2 product RXI-109 continues to show positive results in phase 2a studies against hypertrophic scars. Rxi remains to be a great long-term investment that should yield excellent returns in the near future.
Adamas Pharmaceuticals (NASDAQ:ADMS)
On Wednesday December 23, 2015 went up 54% on positive phase 3 results for patients with Parkinson’s Disease. The phase 3 trial was known as the “EASE” trial, and recruited patients with Parkinson’s Disease. Although, these patients had a form of Parkinson’s known as Levodopa Induced Dyskinesia — LID. These patients with Parkinson’s get LID because of the excess treatment they must be given to manage their disease.
That is because regular amounts of treatment aren’t enough to combat against the Parkinson’s, therefore these patients have to increase therapy to a higher than normal level. The drug used in this late-stage clinical trial is ADS-5102, which is an all oral extended-release capsule drug. LID causes patients to perform involuntary movements that are out of their control. The primary endpoint of the trial was to determine if the drug could reduce LID in these Parkinson’s patients.
Patients were given 340 mg of ADS-5102 taken once daily at bed-time for 24 weeks. The trial met on the primary endpoint on that ADS-5102 was able to reduced LID in Parkinson’s patients compared to a placebo compound within a 12-week period. The trial was statistically significant because the p-value of the trial was p = 0.0009. This p-value had been measured using a rating scale known as the Unified Dyskinesia Rating Scale.
The company is now preparing to get into talks with the FDA to possibly file for NDA approval of this drug. There are no FDA approved drugs to tread LID in Parkinson’s Disease patients therefore a treatment of this caliber will really go a long way to help a lot of people. The company is in great shape as a long-term investment.
Disclosure:The Author Is Long Rxi pharmaceuticals (RXII)
[Image Courtesy of Wikipedia]
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