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On March 23, 2015 RXi Pharmaceuticals (NASDAQ:RXII) first announced preliminary findings from its phase 2a keloid trial study known as RXI-109-1401. This trial is evaluating the ability to reduce patients’ recurrence of keloids following keloidectomy. This phase 2a trial is ongoing and the data is currently being analyzed for future results. At the moment, though, the company had an expert panel comprised of dermatologists, plastic surgeons, and investigators themselves running this study. This panel took a look at 7 preliminary blinded keloid photos and determined that RXI-109 fared better than placebo. That is, this panel identified that the placebo compound showed a greater increase of recurrence. Which means RXI-109 did a better job of keeping the connective tissue growth factor (CTGF) down compared to its placebo counterpart. The key part of RXi’s press release:
“Based on these preliminary clinical observations, a reduced recurrence of keloids treated with RXI-109 as compared to placebo, this Clinical Advisory Panel provided a unanimous recommendation to the Company to lengthen the treatment regimen and to increase the number of doses with RXI-109 to reflect the chronic and aggressive nature of the formation process of a keloid. The Company will move forward with those recommendations and initiate an additional keloid trial in the near future. “
The press release indicates two key conclusions: the first, that keloid recurrence has no FDA-approved product treatments and is a very aggressive disease to treat. The second is that the trial is not a failure. Yes, the company must initiate another keloid trial, but the panel concluded that RXi must increase the dosing from 4 injections weekly in a one month period to more injections in that same month period and a longer treatment cycle covering the longer portion of the proliferation phase — this is the phase where the keloid continues to grow. By providing additional injections of RXI-109 over a long period of time, RXi can improve upon the efficacy of the trial greatly. One key takeaway from the keloid panel finding is that the panel didn’t dismiss RXI-109 completely. They saw that it performed better than placebo. Had the panel concluded that placebo fared better than RXI-109, that would have been a different story. Then you could say the trial failed; but the trial didn’t fail, and as such the company is moving forward.
The first hypertrophic scar study was known as RXI-109-1301. The company has already reported that initiating treatment with RXI-109 two weeks after removing the hypertrophic scar was better than initiating treatment immediately. Even in the one month and 3 month time points RXI-109 was identified more over placebo. But despite that, the company started a second hypertrophic scar study RXI-109-1402 and RXi has already adjusted to add more doses and increase treatment through the proliferation phase to increase efficacy outcome here as well. The RXI-109-1402 study has completed 50% enrollment and when the company gets full enrollment it should release the phase 2a preliminary results of that trial.
Samcyprone was acquired by RXi Pharmaceuticals back in Feb of 2015 and now the company plans to keep the compound moving forward. Three key events from today’s press release are:
RXi Plans to initiate a second phase 2a trial for the treatment of warts by the end of 2015
Collaboration with Dr. Jame Krueger of the Rockefeller University to study the effects of Samcyprone in patients with cutaneous metastases of solid tumors and melanoma.
Collaboration with Dr. Maria Hordinsky at the University of Minnesota to study the effects of Samcyprone in patients with Alopecia Areata (hair loss)
The collaborations and trials of Samcyprone are not only important for RXi to advance in terms of other mid-stage clinical compound but also for the fact that the company may be able to incorporate its sd-rxRNA self-delivering RNAi technology to Samcyprone itself. That is because Samcyprone has immunotherapeutic effect in that it alters the expression of genes and miRNAs — messenger RNAs.
RXi’s share price has seen some pressure lately but at the same time it has been trading at around eight times its normal trading volume. The company is moving forward with its clinical trials as RXI-109 continues to work, and further results should be read out in the coming months. RXi just needs to fine tune the doses and treatment time to get the dosing right. With scars you can’t just put a high dose and knock down 99% of the genes for example because then the company would inhibit the wound from healing. With treating scars the dosing can’t be too high and it can’t be too low nor can you judge how many doses are needed. That’s why RXi made all of its trials as adaptive protocol type trials, because then it can adjust dosing during the trials as needed. This is still a speculative biotechnology stock but at the moment RXI-109 has performed better than placebo in all of the phase 2a trials. If RXI-109 can pass through all the trials and the FDA for approval then it would make history as the first FDA approved drug products for hypertrophic scars and keloids. Right now there are no FDA approved drugs for scarring so it may be a good idea to keep RXi on your radar.
Disclosure: Long Rxi Pharmaceuticals (RXII) |
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發(fā)表于 2015-3-6 11:49:33
