One of the few companies still pursuing the dermal scarring market is RXi Pharmaceuticals Corp. (OTCQX: RXII). Founded by a Nobel prize winner for RNAi therapeutics, the company treats dermal scarring by silencing the expression of one of the associated genes. Early clinical trials showed that its RXI-109 was safe, well tolerated and silenced the CTGF gene in a dose-dependent manner.
With over $15 million on its balance sheet, RXi Pharmaceuticals has enough cash to last until mid-2015 while EMA Specials approval in Europe could enhance this cash flow over the near-term. Successful approval by the FDA and EMA could equate to blockbuster potential given the large addressable market and lack of treatment options. Before that time, the company could also start to see some acquisition interest, particularly given Pfizer’s interest in EXC-001.
I saw some people sold their shares. And longs seem to stop talking in YMB?
I am still holding. The fundamental of this company did not change. Hope this stock will go up at begining of next year.
Bringing a new drug to market usually takes more than a decade and tests in thousands of patients, and costs more than $1 billion. Companies can't afford many studies like that, and patients can't wait years for potentially life-saving new medicines. In the conference in San Antonio MD Anderson revealed it has developed a new method of early discovery of efficacy for new drugs. It involves statistical analysis which gives guidance during a study instead waiting to examine data after a trial is over. The method involves studying drugs in small groups of people and using advanced statistical techniques to analyze the results as they come in, instead of waiting for all the data to arrive.This method allows the company to determine if a drug is worth pursuing, or if it shows promise, it helps tailor the drug to enhance results and treatment of later subjects. The FDA said it could approve drugs without a Phase III trial based on the data gathered this way. A Phase III could be undertaken as a confirmation.
If RXI-109 could use this trial protocol, we may see the trial result early!
What RXi management can do to have RXII listed in NASDAQ? In July the management did 1:30 reverse split in hope RXII can be listed in NASDAQ. But the price dropped and NASDAQ required RXII PPS to above $4 to be listed. 5 months passed, the PPS still around $3. What RXi management can do to have RXII listed in NASDAQ? Partnership with big Pharmaceutical?
Dr. Reni Benjamin is a managing director and equity research analyst at H.C. Wainwright & Co. His expertise and coverage focuses on companies in the oncology and stem cell sectors. Benjamin has been ranked among the top analysts for recommendation performance and earnings accuracy by StarMine, has been cited in a variety of sources including The Wall Street Journal, Business Week, Financial Times and Smart Money, and has made appearances on Bloomberg television/radio and CNBC. He authored a chapter in “The Delivery of Regenerative Medicines and Their Impact on Healthcare,” has presented at various regional and international conferences, and has been published in peer-reviewed journals. He currently serves on the UAB School of Health Professions' Deans Advisory Board. Prior to joining H.C. Wainwright, Benjamin was a managing director and senior biotechnology analyst at both Burrill Securities and Rodman & Renshaw
The Life Sciences Report Interview with Reni Benjamin (12/12/13) "Other companies in the RNAi space include RXi Pharmaceuticals Corp. . . RXi is different, in that its compound's structure seems to attribute unique characteristics that facilitate delivery. It doesn't seem to have the need for a delivery molecule, and based on the preclinical work that the company has shown, its platform demonstrates robust entrance into the cell. . .RXi [is one of the] key players in the RNAi space that I think show significant promise. RXi is relatively new in the field, with a strong intellectual property position and a compound, RXI-109, currently being evaluated in a phase 2 trial as a post-surgical antiscarring agent. Data are expected in H1/14. We are agnostic, if you will, to the company's therapeutic focus, dermal scarring. What we do like about this indication is that it's topical. This oligo does not have to be injected systemically, with the hope that it gets to the scar area. From a clinical trial design point of view, this is a very intriguing indication.
"From a target perspective, RXi is going after connective tissue growth factor, which appears to be overexpressed in scarring and fibrotic diseases. The inhibition of that mRNA works very well with the mechanism of action of RNAi. From a clinical trial perspective and a science perspective, we think RXi has a lot going for it, and the company is not well known in the marketplace. It is a company that investors should definitely take a look at. . .the company is taking out one potential hurdle. Typical RNAi therapeutics are intended to be given systemically. They have the potential for degradation before ever getting into the target tissue, or there may be trouble getting enough drug to the target tissue. That is not the case with RXi's therapeutic." More
Bevasiranib was the asset of Opko, which stopped during P3 trial. RXi is going to reengineer Bevasiranib by sd-rxRNA technilogy to increase cell uptake. . Since sd-rxRNA passed the safety test and Bevasiranib also passed safety test, this new Bevasiranib with sd-rxRNA could directly going to P2 trial?
This will bring extra cash to the company. plus the sales of RXI 109 in Europe. RXi may not need any ATM.
At the Jefferies Global Healthcare Conference Cauwenbergh indicated that the company may seek licensing arrangements with other companies that developed siRNAs that effectively silenced their targets but failed due to delivery issues.
With Market Cap only 33M, it is only 11.6M shares. If someone starts buying, the PPS with double soon.
rmsacc, can you explain why Pfizer has a lot to do to catch up with RXI.. Thanks!
Is that RXi has better technology? But EXC 001 also has RNAi technology.
rmsacc, I have no idea why still in P2.
Here is the study.
A Phase 2, Randomized, Double-blind, Within-Subject, Placebo Controlled Study to Evaluate the Efficacy and Safety of PF-06473871 in Reducing Hypertrophic Skin Scarring
Primary Outcome Measures:
Physician Global Assessment (Overall Opinion POSAS) [ Time Frame: Week 24 ]
Secondary Outcome Measures:
Physician Scar Assessment (Complete POSAS) [ Time Frame: Wks 8, 11, 18 and 24 ]
Patient Global Assessment (Overall Opinion POSAS) [ Time Frame: Wks, 8, 11, 18, and 24 ]
Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) [ Time Frame: Wks 8 and 24 ]
Physician and Patient Photoguide Scar Assessment [ Time Frame: Wks 8, 11, 18 and 24 ]
Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Study Completion Date: August 2014
In clinicaltrials Pfizer is redoing P2 trial again. Now called PF-06473871. Anyone knows which route it is administered? Given by local, just like RXI-109? or Intravenous?