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May 8, 2013: ZLCS entered a purchase agreement with Lincoln Park Capital Fund, LLC to sell up to $25 Million worth of shares.
As of June 30, 2013 ZLCS had $20.8 Million in Cash .
ZLCS expects resources to be sufficient until first quarter of 2014.
Shareholders meeting voted for no dilution!
http://t.co/O7hIqoGsrI $ZLCS MOVING UP TO $1 next week!
$ZLCS Next week every indications show this stock is going to move up on expecting top of line results from Z160 P2 trials!
Each company must have a minimum of 1,250,000 publicly-traded shares upon listing, In addition, the regular bid price at time of listing must be $4, and there must be at least three market makers for the stock. However, a company may qualify under a closing price alternative of $3 or $2 if the company meets varying reequirements. Each listing firm is also required to follow Nasdaq corporate governance rules 4350, 4351 and 4360. Companies must also have at least 450 round lot (100 shares) shareholders, 2,200 total shareholders, or 550 total shareholders with 1.1 million average trading volume over the past 12 months.
Rhino posted in YMB
Per the Captain
Per the Captain: Take this bash it, pump it, spin it, I’m delivering the word from the chief’s mouth.
1 . 9:00 - Prialt acts as a clinically validated target for Z160. This provides guidance for where the drug must target. If Zlcs is able to hit this target it is expected to see the analgesic effects validated by Prialt.
Z160 demonstrates robust efficacy across a wide range of animal pain models and the highest dose shows no rotarod response.
Chung Model 13:30 – Most predictive model in measuring efficacy in Humans – At the highest doses the studies show that Z160 is on par with Prialt (Conotxin) and Gabapentin. **** Key take away - Comparable to competition without the harmful side effects.
2. 10:15 - Safety Database confirms that over 450 patients have been exposed to Z160. At the highest dose given “The database continues to grow without very severe consequences and to date (Sept 8 2013) we have not seen any neuro-psychiatric side effects. He believes this is a result of Z160 being state dependent.
3. 14:31 – Bioavailibilty – Original formulation (225mg) shows a Plasma Concentration of 65 vs. the new formulation (225mg) with a Plasma Concentration of 553. This is an 8.5 fold increase. 15:09 - “This gets us to the blood levels we believe are going to be necessary for efficacy. AUC scores - Original formulation 500 concentrations with 225 mg and new formulation of 225mg shows a 5.2 fold increase to over 2,500.
4. 17:15 - PHN is the Gold Standard for accessing clinical efficacy in neuropathic pain. This trial is well established with standard outcome measures and a clear development and regulatory path. Pfizer paved the regulatory path and many of those features are in Z’s PHN trial.
PHN also provides ZLCS with the potential for Orphan Drug designation.
Both trails are under a very efficient trail management program and results are scheduled Q4 and data has been brought to Z quickly. Corrigan sees Z160 as a value driver.
Also noted: z160 potentially poised for a Phase 3 start at the end of next year or early 2015. Z944 1B results by EOY and Corrigan is hopeful for another clinical candidate by the end of the year. Z is continuing their ongoing research with their collaborative partners on efficacy in cancer.
$ZLCS Per Q2 10Q,Zalicus has until Oct 21to regain compliance with NASDAQ
As of June 30 Zalicus sold 6.1M shares to LPC,
With LPC buying. we expect good news!
I hope Zalicus will have partner before the end of Sept, just like INO!
Does LPC start buy?
Why today drop on good news?
Why sell on good news? Any bad news leaking? Does the R /S come?
CHTS will help Zalicus get milestone payment from Novartis!
Next Monday R&R Conference, Corrigan will talk something news!
Z212 news will be out!
Big Red is still alive, P3 will be started any time!
Z944 news will be out soon!
You are right, last Friday my order did not get filled! This PPS dropped was not real!
Trading stop? Buyout? Moving to NASDAQ?
Vitaros has to be applied to urethral meatus?
Can it be applied to the skin of glans of penis? it is easier and more comfortable.
Instructions For Applying Vitaros: Apply Vitaros to the tip of the penis (meatus) within 5 to
30 minutes prior to attempting intercourse according to the following directions:
1. Wash your hands before applying Vitaros. Remove the AccuDose dispenser from the foil
pouch.
Remove the cap from the tip of the AccuDose dispenser (See Figure 1).
2. Grasp the tip of the penis and gently manipulate to widen the opening of the penis (See Figure
2). Note: if you are not circumcised, first retract and hold the foreskin back prior to widening the
opening of the penis.
3. Apply as much cream as possible to the opening of the penis by holding the tip of the
AccuDose dispenser above the opening of the penis and slowly depressing (over 5 to 10 seconds)
the
plunger until all of the cream is expelled from the AccuDose dispenser barrel.
Do not insert the tip of the AccuDose dispenser into the penis (See Figure 3).
4. Hold the penis in an upright position for approximately 30 seconds in order to allow the cream
to penetrate. Any excess cream covering the opening may be rubbed gently into the application
site
(glans) with the tip of the finger. The amount of excess cream will vary depending on the patient
and it is not unusual that up to half of the dose will remain at the edge of the opening.
Is Vitaros curretly an urethral suppositories or it can be applied to penile skin? I think massaging to skin is easier and less irritation.
Vitaros is expected to sell in Canada in November, 2013!
http://buyalprostadilcream.com/vitaros-cream-alprostadil-for-ed-launch-date-and-availability/
Chevelle, if those are the findings by cHTs, when in clinical trial, Novartis should pay milestone to Zalicus. But so far we did not hear such news.
Thank you very much! It is always helpful to hear accurate information from you! I will buy more shares in the future!
Thanks! Why they did not proceed with US approval?
www.clinicaltrials.gov/ct2/show/NCT01810575?term=alprox+td&rank=19
Efficacy & Safety of Single Dose Alprostadil Cream (2 Concentrations Enhancer) to Vehicle in Men w/Erectile Dysfunction
This study has been terminated.
(Re-assessment of study)
Sponsor:
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT01810575
First received: February 27, 2013
Last updated: August 5, 2013
Last verified: August 2013
Vitaros trial has been terminated by Warner Chilcott?
What does this mean?
Apricus Biosciences just filed its Notification of inability to timely file Form 10-Q or 10-QSB
http://www.sec.gov/Archives/edgar/data/1017491/000119312513329357/0001193125-13-329357-index.htm
Good help on this Board. Way better than YMB. Thank you everyone who answer my question! Hope to see Vitaros launch soon!
Thanks for answer my question, I plan to buy more, but little bit hesitate to do so.
Do you mean the company hold Vitaros to the market, and waiting for this P4 trial coming out at end of 2015?
Could anyone explain to me why Abbott did not sell Vitaros in Canada after approved for two 2 years? What is the reason Vitaros did not launch in Europe after approved? Are they waiting for room temperature Vitaros?
When YMB will be available for RXIID?
The shares they bought is so small, I do not see this insiders buying has any impact!
$RXIID For a company just finished P1, does it worth $5? This 1to30 R/S is too much! Maybe the company plan for Public Offering!
$zlcs investors have a interest to get this over $1 for 10 days to avoid reverse split. then good data will blow it wide open. Long
Napadano predicted a R/S in his SA article a few months ago, AND didn't say it wouldn't happen in Recent SA article. let's just hope this recent news will do the job to prevent it, but, more news is needed...
good news, but it only 500 shares?
$RXIID diluted its shares by issuing ATM.
http://rxii.ir.edgar-online.com/fetchFilingFrameset.aspx?FilingID=9416481&Type=HTML
I think the winning for RXIID is its unique RNAi delivery system. So far RXi approved it is very effective.
After this R/S, the PPS up to 4.8/shares now. For a company only has one drug on P1, is this price to high? What is the management thinking?
RXi Pharmaceuticals' Geert Cauwenbergh Discusses Business & Catalysts
Published Thursday, July 25, 2013 by Steve Haas
http://secfilings.com/News.aspx?title=rxi_pharmaceuticals's_geert_cauwenbergh_discusses_business_&_catalysts&naid=481
RXi Pharmaceuticals' Geert Cauwenbergh Discusses Business & Catalysts
Published Thursday, July 25, 2013 by Steve Haas
1. Can you put the early results from RXI-109 into context for investors? Why did you choose to target this market? How large is the market? And, how do you plan to break into the market?
These Phase 1 results do a lot more than just confirming that RXI-109 is a safe compound for use in humans. (1) The results actually confirm that our drug indeed works through the highly selective and specific RNA interference mechanism. (2) They confirm that the compound is long acting with statistically significant and dose dependent reduction of CTGF protein 3 months after one single dose, and (4) they confirm that this reduction in protein is preceded by a dose dependent reduction in mRNA levels for CTGF. (5) Finally, these results are the first time ever that the self delivering (sd) approach that RXi Pharma has followed is effective in humans, and that it could play a significant role for the translation of the RNAi mechanism into clinical practice. Our choice to target this market is a rational one. Hypertrophic scars and keloids are medical issues that have very few effective treatments, if any. Beneficial effects can be seen with the naked eye. Clinical studies in skin disorders are less costly than many clinical trials in internal medicine. Abnormal scarring is esthetically not very acceptable, and an important factor in an increasingly affluent society that values external beauty and cosmetic elegance. With more than 40 million surgical procedures in the USA every year, and assuming that 20 to 25% of these patients could be good candidates for a compound like RXI-109, the market potential of the product could easily exceed $1 billion per annum. Breaking into this market should be relatively straight forward, as the core physician groups that would use the product are well known: dermatological and plastic surgeons. In a second wave other surgical specialties will be approached.
2. In light of your Phase 1 results, you may have noticed the results Alnylam presented last week for their clinical program. Where do you place their 80% reduction in protein in context with your 43% reduction in mRNA level?
I was surprised when I noticed that some people have actually tried to compare these 2 compounds. It makes no sense, as it is like comparing apples and oranges. First of all, we have looked at protein levels of CTGF as well as the mRNA levels for that protein; and RXI-109 targets abnormal scarring of the skin. The Alnylam compound is targeting a completely different and genetically altered protein (TTR) and focuses on amyloidosis in the liver. CTGF is a normal protein that is needed for wound healing, and hence complete silencing of the protein could have a negative consequence on the normal wound healing process. Consequently it is good for RXI-109 not to suppress the CTGF production completely. In the case of TTR, we are talking about a mutated protein that is causing issues in the liver. The more you can suppress the formation of that protein, the better for the patient. Also, the doses and route of administration are quite different. The Alnylam compound is used systemically at 2.5 mg/kg. Our compound RXI-109 is used intradermally at doses of approximately 100 microgram/kg, i.e. at 25 times a lower dose. Bottom-line a comparison between the 2 does not make much sense.
3. Can you discuss some of the early indications of efficacy from the Phase I trials? It sounds like the mechanism of action has been shown to be successful, so how confident are you going into Phase II trials?
We indeed have shown that the RNA interference mechanism is the way RXI-109 works. Obviously, in Phase 1, we have treated volunteers who did not have abnormal scars. Patients with hypertrophic scars and keloids have very high elevations of CTGF, much more than normal volunteers. Hence we are certainly encouraged that we have a significant effect on the CTGF expression. Our Phase 2 studies will tell us if such suppressive effects can also be achieved when there is significant overexpression of the protein, and what doses we will have to use in order to achieve a clinically relevant effect in these abnormal scars. The fact that a single dose of RXI-109 still had a significant and dose dependent suppressive effect on CTGF 3 months after administration gives us hope that we should have some interesting clinical observations. You are probably aware of the antisense molecule EXC-001 that blocked CTGF and that has shown nice results in Phase 2 a studies.
4. Pfizer is currently working in Phase 2 on the antisense molecule against CTGF for dermal scarring you mentioned in the previous answer. How does RXI-109 compare to this antisense product?
Although also in this case a comparison is a little bit in the apples and oranges category, at least the disease area and route of administration are the same. There are a number of theoretical and technical reasons why an antisense like EXC-001 and an sd-rxRNA like RXI-109 could be different. The fact is that until today no direct comparisons have been done between the 2 products. Data presented by Pfizer in a poster suggest that in human Phase 1 studies, EXC-001 was able to suppress mRNA of CGTF for about 30 to 40%. They have shown also that this resulted in very relevant clinical benefits for patients after scar revision surgery. We have shown more than 40% suppression of the CTGF protein, and have used doses that were somewhat lower than those used for the Pfizer compound. This is obviously encouraging, but I still want to see the results in the target patient population.
5. Can you discuss your commercialization strategy for RXI-109? Do you plan to partner with a larger pharmaceutical company or pursue development independently? What's the timetable to market in broad terms?
It is early days to discuss commercialization strategy for RXI-109. Something that is quite likely to happen, is that we will look early on for one or more partners for ex-USA. RXi Pharmaceuticals is still a very young company in its current form; hence taking on the world as a market is likely best done in good partnerships with strong commercial organizations in the various geographies. When it comes to the US, co-development and co-marketing are certainly a possibility, but we would also like our shareholders to get the extra benefit in value from our own commercial activities in the biggest market in the world, the USA.
6. Can you discuss other candidates in your clinical pipeline? Aside from RXI-109, what are some other RNA-based therapeutics that you believe hold significant potential for investors?
RXi Pharmaceuticals is well positioned in the RNAi space because of its dominant position in the self-delivering technology for use of siRNAs. We call our compounds sd-rxRNA because of this self-delivering technology; i.e. no need to use various formulation vehicles to bring the compound to the site where it is supposed to act. We have of course various therapeutic categories we could play in, but, because of the great preparatory work that has been done by our team in RXi, the ophthalmology pipeline really stands out as a unique opportunity, with some attractive developments in preclinical testing (proliferative vitreoretinopathy, macular degeneration and retinoblastoma). Now that we have been able to get RXI-109 ready for transition in Phase 2 clinical testing in patients, we should be able to focus more on advancing our ophthalmology pipeline. Considering the substantial interest the ophthalmology space has received in the last few years, also here some good partnering and co-development opportunities should exist.
7. Where do you see the value of the Opko assets that RXi acquired a few months ago?
The value of the Opko siRNA assets comes from the patent estate. There are several patented sequences in that estate, several of which have good underlying pharmacological data. Of course, these are predominantly naked siRNAs and as such will be limited in their capability to penetrate into the diseased tissue. The synergy with the RXi technology platform can come from the fact that these known and often potent sequences might be valid candidates for our self-delivering approach. This could further jump-start our pipeline of clinical candidates in the years to come.
8. What would you say to investors interested in buying your stock right now?
I would say that reading about our company, and digging into the understanding of our technology will help new investors to really understand why the RXi approach to delivering RNAi technology is a potential winner on a broad front of therapeutic applications. RXI-109 is a first clinical development candidate that, because of its potential activity in a highly attractive market (skin scarring) has significant potential to create a lot of value. That however is only the surface. The RXi Pharmaceuticals platform has such a broad spectrum of therapeutic possibilities that, over time, it could become a biotech blockbuster of its own. The earlier you get invested into such a company with a potentially transformational platform, the higher the return on investment could be. ?
9. We noticed the reverse split and the application to list on the NASDAQ Capital Markets. Any comments on that?
As you can imagine from the previous comments in this interview, being able to get exposure and interest from large institutional investors is key for a corporation that could become the next large biotechnology company. In order to be on the radar screen of these large institutional investors, a share price as a "penny stock" is not appealing. Our reverse split has been carefully discussed internally and with financial advisors, and the consensus was that doing it at a moment that the Company has shown great progress in their clinical development, and not just before a new financing was the right approach. With the NASDAQ being the premier technology exchange we felt that an application in parallel with the reverse stock split would underline the intrinsic strength of RXi Pharmaceuticals and provide a clear signal that the Board and the management team of the company are strong believers in the potential of the company going forward.