Apollo Endosurgery

... keinen Kurs führt, daher Doppleposting: Chalif, was sagst Du? http://finance.yahoo.com/news/lpath-present-trial-progress-poster-120000597.html

New Published Paper Shows Efficacy of Lpath's Anti-LPA Antibody, Lpathomab, in Traumatic Brain Injury Models Publication Further Validates Lpath's Approach to Targeting Bioactive Lipids for Drug Discovery Lpath, Inc. March 5, 2014 7:30 AM SAN DIEGO, March 5, 2014 /PRNewswire/ -- Lpath, Inc. (LPTN), the industry leader in bioactive lipid-targeted therapeutics, has brought scientists one step closer to finding a potential treatment for traumatic brain injury (TBI) with a recent publication showing that Lpathomab™, a therapeutic antibody, reverses much of the damage caused by trauma to the nervous system. As published by the Journal of Neuroinflammation (vol. 11, article 37), Lpathomab can be used to reduce the size of a TBI and to improve functional behavioral outcomes in experimental animal models. The antibody works as a molecular sponge by soaking up lysophosphatidic acid (LPA), a molecule that can damage neurons and promote dangerous inflammatory responses in the central nervous system. In collaboration with scientists at the University of Melbourne, the antibody was tested in mice that had TBIs. A key finding of the study was the significant efficacy of administering Lpathomab after an injury, thus demonstrating a potential therapeutic benefit. Also shown for the first time in this groundbreaking paper was that human patients with TBI exhibited substantial increases in the levels of LPA in the cerebrospinal fluid (CSF) after injury, a finding also seen in the injured mouse model of TBI; such data suggest that LPA is a valid target for therapeutic intervention. Lpath and its Melbourne collaborators have recently shown that Lpathomab provides protection against neuronal cell death and scarring in experimental models of spinal cord injury (SCI), published recently in the American Journal of Pathology (Goldschmit et al., vol. 181, p. 978-992). Currently, there are no FDA-approved drugs for the treatment of neurotrauma such as TBI and SCI. "This research provides new hope for therapeutic treatments for many forms of neurotrauma, including TBI and SCI as well as other forms of neurodegenerative disorders," said Roger Sabbadini, Ph.D., vice president and founder of Lpath and co-author on the paper. "We believe that LPA may be a biomarker that could be used to aid in the diagnosis of TBI, as the 'LPA pulse' that occurs in the injured brain can also be detected in blood." The research team was comprised of Lpath scientists and collaborators from the University of Melbourne, Monash University and the University of Kentucky. As a promoter of tumorigenesis, metastasis and fibrotic disease, LPA is a well-validated drug target and has been shown to play a significant role in neuropathic pain and now neurotrauma. The role of LPA in the nervous system has been described in a recent review published in the International Review of Cellular and Molecular Biology (Frisca et al., vol. 296, p. 273-322). Lpathomab is currently in IND-enabling studies for neuropathic pain and neurotrauma. Lpathomab was generated using Lpath's proprietary ImmuneY2™ technology, a drug-discovery engine that provides Lpath with a platform to generate antibodies against bioactive lipids, opening up a new array of drug-discovery possibilities. About 1,000 bioactive members of the lipidome are believed to exist, but the number could be considerably larger as the study of lipidomics continues to expand. Nature Reviews stated that bioactive lipids promise to occupy center-stage in cell biology research in the twenty-first century. Lpath utilized ImmuneY2 to discover an antibody against another bioactive lipid, sphingosine-1-phosphate (S1P). This antibody, sonepcizumab, is formulated as iSONEP™ for ocular delivery and as ASONEP™ for systemic delivery. In addition, the ImmuneY2 platform was used to generate Altepan™, an antibody against key leukotrienes that have been implicated in various respiratory diseases, including asthma

Ich weise noch einmal ausdrücklich darauf hin,das ein Invest in LPTN zu diesem Zeitpunkt als hochriskant bezeichnet werden darf,da erstens die Kohle im Dezember 2014 alle ist und die wichtigen Daten zu ISONEP und ASONEP erst im Dezember kommen,d.h. ich würde unbedingt erst mal abwarten bis Dezember,wenn sich definitiv entscheidet,ob LPTN den Bach runter geht oder durchstartet,ausserdem scheint mir die Alternative mit Immmunomedics sehr in teressant zu sein,IMMU ist zwar 8 mal so teuer wie LPTN,hat aber alle antikörper bereits in Phase-3 und ist sehr gut durchfinanziert,ausserdem warten wir bei IMMU auf die Ergebnisse des Lupus-antilörper,wir erinnern uns dabei an Human Genome Science (HGSI),die gleich 5000% Am Stück explodiert sind ,als positive Results zu deren Lupus Medikamt Benlysta überraschend veröffentlicht wurden ...... Hals und Beinbruch wünscht ..... MFG Chali

One of the hardest goals to accomplish within the biotechnology sector is to find a stock that has the potential to be huge within a few years. I believe that LPath (LPTN) represents a significant opportunity for investors, and thus represents a compelling chance at significant upside for investors who are focused upon the long term. Currently, LPath has a promising pipeline that is progressing through the stages of clinical development, and this pipeline represents a compelling opportunity for investors. Add in the fact that LPath has a partnership with one of the largest pharmaceutical companies in the world for a rather important product, and the potential for this small cap stock does seem to be very large. LPath appears to be a compelling buy at these levels and should offer solid returns for long term oriented investors. The Pipeline LPath has a mid-stage pipeline with its lead product candidate in Phase II testing. Below is a diagram detailing the pipeline at LPath: iSONEP ASONEP Lpathomab Nextomab Partnered with Pfizer (PFE) Pfizer right of first refusal Not partnered Not partnered Indicated for Wet AMD,RPE Detachment, and Diabetic Retinopathy Indications:Cancer, MS, Inflammation, Colitis Indications: CNS Disorders, Pain, Fibrosis, TBI Indications:Inflammation, Cancer, Ocular Phase 2 testing Phase 2 testing Preclinical Discovery This chart allows for us to draw some very interesting conclusions right off of the bat. First of all, LPath is partnered with Pfizer for its lead product candidate (which would of course mean that there is a large amount of potential) and secondly the pipeline is not very advanced yet, which could of course help to explain why the stock price and the market cap are rather low for this company. In order to evaluate the merits of an investment in the company, and in order to chart the potential for the company it becomes necessary for us to dive in much deeper into the actual pipeline candidates at LPath in order to truly see the potential. iSONEP iSONEP is perhaps the most important immediate product to the future of LPath. iSONEP is designed to help treat a myriad of different opthomological problems. While we do not have a great deal of data on the product, due to the product only being in phase II testing, it appears as though the product has significant potential over the long run. Up to this point the Phase I trials in wet AMD have been rather good. First of all the drug was well tolerated by the patient population, and investors were given hints as to the efficacy of iSONEP as either a first line treatment or as an adjunct therapy. In the phase I trial a positive biological effect was observed in most patients, do not forget that these are the patients who failed treatment with the current standard of care Lucentis and Avastin. This patient population, failing the current standard of care, would of course be harder to treat, and therefore any hint of efficacy within the population can be positive for LPath. The product is currently being studied in Wet-AMD, with results expected in the third quarter of 2014. The Phase I study was completed quite a while ago, and the delay heading into Phase II testing is solely based upon an FDA hold. Now, I know what you are thinking, but this was not an FDA hold that had anything to do with the product in question. LPath's fill/finish contractor was not in compliance with the FDA's Good Manufacturing Practice Requirements and as such the FDA put a clinical hold on LPath until the supplier either came into compliance or until LPath found a new supplier. With the supply issues now having been worked out, this should not be an issue going forward for shareholders and should not delay the development timeline any further. This product is important, as it is currently partnered with Pfizer.Pfizer has the worldwide commercialization rights for the product candidate. Pfizer is currently sharing the costs of the Phase II Nexus trial with LPath, at which point Pfizer will have to make a very important decision after the data readout. Under the terms of the agreement Pfizer has two options: 1) Exercise its option to develop the product candidate, or 2) Lose all of its development rights. Should the data be positive, the decision of Pfizer will likely be the former. This can be very lucrative for LPath for the following reasons. Upon Pfizer exercising its option, Pfizer will pay an undisclosed sum to LPath, Pfizer would be responsible for the costs of all future commercialization activities, LPath would be eligible for milestones of up to $497.5 million in development and commercialization goals, and LPath would receive a tiered double digit royalty on any product sales. This agreement has the potential to be very important for a company that has a rather small market cap and could provide a very large amount of revenue going forward. However, Pfizer recently announced that it is looking to divest some of its ophthalmology assets, and that its iSONEP worldwide rights is one of the assets being divested. The bright side of this is that a sale to a third party does not change the terms of the partnership agreement, and that third party would still have to pay all of the money that Pfizer would have to pay. There also appears to have been substantial interest in the iSONEP option as it was recently announced that iSONEP's bid to regain the rights to worldwide commercialization was not the highest and that there were other offers that were more competitive. With this in mind, there appears to be significant interest in the iSONEP asset which bodes well for the future of the program. The phase II nexus trial seems as though it will be quite extensive, and that is should provide a much better idea as to the future of the iSONEP asset. From a risk-reward standpoint, should the trial be positive then the stock should go up significantly based on the future partner exercising their development rights to the product. Whereas if the trial fails then that would likely be a rather big blow to the overall future of LPath. However, given the promising phase I trial results I am predicting success for the Phase II trial. iSONEP is also looking at potential indications in retinal pigment epithelium detatchment (RPE). Any additional indications would, of course, add value to the asset and would increase the commercialization potential of the asset. The significant sales potential of the asset, coupled with the fact that LPath would get the revenue for almost free (considering that past phase II trials the revenue would come in as development milestones and royalties), this product has the potential to help guide the future of LPath for years to come. ASONEP Asonep is another very promising product in LPath's pipeline which is capable of helping to drive long term shareprice growth going forward. ASONEP is being studied in a variety of indications, but is also a product associated with the Pfizer agreement. Pfizer currently has for a limited time the right to first refusal to partner on ASONEP. This product has the potential to generate significant revenue going forward for LPath, should Pfizer choose to partner on the product. ASONEP is also currently in phase II testing in Renal Cell Carcinoma (RCC). What is significant about the phase II trial is that LPath is choosing patients who have either failed three prior treatments for RCC, or who have RCC that is inoperable. These patients would be harder to treat than average RCC patients, and this is significant because if ASONEP is able to show benefits with a rather clean adverse effect record it should be well on its way to achieving FDA approval. According to clinicaltrials.gov (linked earlier on in the paragraph), the estimated Primary Completion Date for the trial is in December of 2014. This means that we should see data pretty soon after the primary completion date for the trial so I would tentatively predict data in either January or February, this would mean that while results are far away investors might be able to get in now at a low price and then benefit from a significant runup heading into the final release of the data. with the importance of the Phase II data in mind, lets take a quick peak at the Phase I data and see if that can give us any insight as to the possible outcome of the Phase II trial. The Phase I trial was largely successful. The drug was well tolerated with no adverse side effects. Significantly many of the patients that were studied achieved 'stable disease' in regards to their cancer size. This is important because that would mean that the drug stopped the growth of cancer and would help to suggest that the drug does have the potential for a rather large amount of efficacy. It is also worth pointing out that while LPath is paying for the trials, the phase I and IIa trials are being funded in part by a $3 million grant from the National Cancer Institute. This will help to offset some of the funding costs for the trial and should help to save LPath money over time. Further clinical trials may be paid for by Pfizer, should it execute an agreement similar to the one existing for iSONEP. Also, having such a well respected agency such as the National Cancer Institute helps to show that this program is needed amongst the cancer community and that the treatment represents a meaningful step forward for patients. The market for ASONEP could be very large, even if it is considered to be a second line therapy. There are, unfortunately, 225,000 new cases of Renal Cell cancer every year in the world. With a market of this size, it would be possible for LPath to carve out a very lucrative niche, especially should it successfully partner with a large pharmaceutical company like Pfizer. ASONEP will be an asset that investors will pay close attention to and the possible addition of a Pfizer partnership would only add value to the program. ASONEP has the potential to help drive long term shareprice growth and to provide significant returns for investors. Other Pipeline Products The two pipeline products covered above are well ahead of the other development programs in LPath's pipeline. As the pre-clinical Lpathomab continues to advance within the clinical trial process it should help to drive shareholder growth. Interestingly, the Lpathomab program was recently the recipient of a $145,000 grant from the National Institute of Health to help fund the expenses associated with a phase I trial.In pre-clinical data Lpathomab showed the ability to significantly reduce pain, which represents a potential path forward for the development of the product. Nextomab is still in the discovery phase and as such investors do not know a great deal about the program. It has the potential to help drive shareprice growth as more information about the program is released and as the product candidate advances through clinical testing. Finally, LPath recently announced yet another new drug discovery program called Altepan. The potential indication for this program is in respitory disease, which would of course be a rather large market depending upon the specific indication. The company expects that if the preclinical results continue to come back positive, that they will file an IND with the FDA towards the end of 2015. While this is a rather long period of time away, as the product advances it could have the potential to increase the shareprice and it could be very important for long term oriented investors. Financial Position Another key consideration when looking at investing in any company is the financial position of the company. For a company that is primarily engaged in researching its drug candidates we can expect for LPath to be operating at a loss. It is important going forward, however, for investors to monitor LPath's cash and cash equivalents in order to avoid dilution. As of September 30, 2013 LPath had cash and cash equivalents of $14.9 million. This should be sufficient, given LPath's current cash burn rate, to fund their operations through the third quarter of 2014. Given that fact, it appears as though the immediate risk of dilution is off of the table and I would expect for the company to hold off on dilution until the stock moves higher in anticipation of the upcoming clinical data for iSONEP. The company also has an at the market issuance program which may allow for the company to issue shares to the public from time to time. While this is not necessarily a good thing, the fact that it is in place suggests that LPath might not dilute all at once and instead spread the dilution over time which would be preferable. The limit is $20 million which would help to substantially increase LPath's cash coffers. Also, do not forget that the partnership agreement on iSONEP would provide for a significant payment should Pfizer elect to continue developing iSONEP. LPath does at least receive some revenue due to the grants and reimbursable costs that it has as a result of its partnership programs. This revenue helps to offset some of the impact of the operating loss at LPath. The research and development costs have been increasing through recent quarters, as a result of having to take over the next $6 million in clinical trial costs related to iSONEP and also due to the other drug development programs in LPath's pipeline. While a large loss is usually a concern, for a developmental stage company I am usually willing to overlook the loss. The company is still trying to research its products and as the products advance through the pipeline, investors should see the share price go up despite the losses at LPath. Furthermore, if Pfizer elects to exercise its option this could do a great deal towards helping to minimize the operating loss as LPath would no longer have to spend money on the development of iSONEP. So, in summary, I believe that with sufficient cash through the third quarter of 2014 and the possibility of a Pfizer partnership, that LPath is in a good enough financial position to merit investment consideration. Conclusion LPath's development pipeline will be the long term driver of shareprice growth. The upcoming results for the iSONEP trial represent a meaningful catalyst for long term oriented investors and should help to apprise the true value of LPath's pipeline. It appears as though with LPath trading well off of its 52 week high, that now might be a good time to get into the stock. It also appears as though for the long term, LPath is set up to provide significant returns to patient investors.