Lpath inc. (LPTN.OB)

Dieses erfolgreiche Ergebnis mit Lpathomab folgt dem Erfolg von
Lpath mit seinem Sphingomab(TM) Programm auf dem Fusse. Sphingomab
ist ein Antikörper gegen ein weiteres bioaktives Lipid, das S1P.
Lpath humanisierte den Antikörper im Jahr 2006 und plant die
Einreichung eines IND-Antrags im November dieses Jahres für die
Verwendung von ASONEP(TM) (der systemischen Rezeptur der
humanisierten Form von Sphingomab) zur Behandlung von Krebs. Das
Unternehmen plant ausserdem die Einreichung eines zweiten IND-Antrags
zu Beginn des nächsten Jahres für die Verwendung von iSONEP(TM) (der
okularen Rezeptur der humanisierten Form von Sphingomab) zur
Behandlung von AMD. Die Einreichung eines IND-Antrags für die
Verwendung von humanisiertem Lpathomab ist für das Jahr 2009 geplant.

Dr. Roger Sabbadini, der Gründer und CSO von Lpath, merkte an:
"Diese hoch interessanten Ergebnisse liefern eine weitere Bestätigung
von auf Lipidomen basierenden Therapeutika als ein wichtiges neues
Gebiet der Medikamentenforschung. Lpath war eines der ersten
Unternehmen, das erkannt hat, dass bioaktive Lipid-signalisierende
Moleküle wie S1P und LPA ausgezeichnete Targets für rationales
Drug-Design darstellen können. Durch Verfolgung dieser Targets und
Demonstration der überzeugenden Wirksamkeit haben wir eine gesamte
Klasse von auf Lipidomen basierenden Therapeutika für die Behandlung
von Krebs, Diabetes, neurodegenerativen Erkrankungen,
Immunfunktionsstörungen, Entzündungen, Schmerzen, psychischen
Störungen und Herz-Kreislauf-Erkrankungen eröffnet."

Wissenschaftler sind heute davon überzeugt, dass es mehr als 1.000
Mitglieder des funktionellen Lipidoms gibt, von denen jedes ein neues
potenzielles Ziel für therapeutische Intervention darstellt.

Informationen zu Lpath:

Lpath, Inc., mit Hauptsitz in San Diego in Kalifornien, ist der
Branchenführer bei der Herstellung von auf Lipidomiden basierenden
Therapeutika, einem aufkeimenden medizinischen Forschungsbereich, bei
dem der Einsatz bioaktiver Signal-Lipide zur Behandlung wichtiger
Krankheiten des Menschen untersucht wird. ASONEP(TM) (die systemische
Rezeptur der humanisierten Form von Sphingomab(TM)) ist ein
Antikörper gegen S1P mit vielversprechenden Resultaten bei der
Behandlung von Krebs und anderen Krankheiten. Ein zweiter
Produkt-Kandidat, iSONEP(TM) (die okulare Rezeptur der humanisierten
Form von Sphingomab), hat bereits überzeugende Ergebnisse in
verschiedenen vorklinischen AMD- und Retinopathiemodellen erzielt.
Lpaths dritter Produkt-Kandidat, Lpathomab(TM), ist ein Antikörper
gegen LPA, einem wichtigen bioaktiven Lipid, das schon seit längerem
als ein geeignetes Target für bestimmte Krankheiten bekannt ist. Die
einzigartige Fähigkeit des Unternehmens, neuartige Antikörper gegen
bioaktive Lipide zu erzeugen, basiert auf seiner ImmuneY2(TM)
Plattform zur Medikamentenforschung, die vom Unternehmen dazu
verwendet wird, seine Produkt-Pipeline zu erweitern. Weitere
Informationen erhalten Sie im Internet unter www.Lpath.com

MFG
Chali

... fast allein schreibst?
Bei Med-Werten geht es stets um ein bahnbrechendes neues Medikament, das im Falle der endgültigen Zulassung zur Cashcow werden soll, richtig?

Aber wie blickt man durch? Bist Du aus der Branche?

War das nicht einer Deiner Hinweise auf eine Geschichte à la Schaf Wolf Hyäne?

Ich bin nicht aus der Branche (Maschinenbauingenieur),aber ich habe mich selbst fit gemacht ! Zum Trackrecord: Vor einigen Monaten habe ich gleich 3 Biotechthreads aufgemacht,die allesamt schon super ins laufen gekommen sind,kannst ja mal schaun:

http://www.ariva.de/forum/...-Apple-in-1997-buy-Organovo-today-470965   (200% im Plus)

http://www.ariva.de/forum/Astex-Pharmaceuticals-Hammer-459048  (300% im Plus)

http://www.ariva.de/forum/...uticals-erwartet-top-line-results-484717 (150% im Plus)

..... aber das ist alles nichts gegen das was uns bei Lpath in zukunft erwarten soll ! Schau dir einfach mein Post nr.24 mit Celldex an,die wesentlich weniger auf der Pfanne haben ,aber schon knapp 3 Mrd wert sind ! Das liegt daran ,dass Antikörperaktien in der Regel sehr hoch bewertet sind,auch Seattle Genetics mit 5 MRD oder Regeneron mit 28 MRD ! Alle,nur meine Lpath mit 80 Mio noch nicht ! Ich halte es in der Tat für nicht ausgeschlossen ,dass Lpath in 10 Jahren so hoch wie Regeneron bewertet sein könnte (28 MRD),aber 5 MRD würden mir schon reichen,um 5000% mit meinem Invest einzustreichen,gerade wegen ISONEP ,das Medi hat in Phase 1 bessere Resultate als das von Regeneron bei macluar Degeneration (altersbedingte Blindheit) gezeigt !!!!! Die Finanzierung der Clinicals ist durch eine Partnerschaft mit Pfizer voll abgesichert,keine Insolvenzgefahr,ich warte auf die Phase-2 Ergebnisse ! Die Aktie Lpath ist völlig unter Radar,auch im Amiland nur kleine Umsätze ,so erkläre ich mir die geringe Mkap.

Nunja,ist dir eigentlich schon aufgefallen,dass hier bei Ariva eigentlich ausschliesslich Schrottaktien diskuttiert werden ? Da ist man eben relativ alleine,wenn man eine Biotechperle entdeckt hat,aber der Bierro und die LadyLuck schauen wenigens ab und zu mal hier rein,und jetzt auch du .....

Chali

Im Moment tut der Verlust noch zu weh, als dass ich die übrig gebliebene Kohle leichten Herzens ins nächste Abenteuer schicke. Werde noch etwas lesen hier bei Dir und dann mal schauen.

Das mit dem nur Schrott diskutiert - meinst Du wirklich? Aber wozu magst Du dann hier schreiben?

Ich meine das wirklich ernst. Ich schreibe hier ,weil ich hier Schach spiele in unserem Schachthread ! Wenn du mal Lust auf eine gepflegte Fernschachpartie hast,melde dich einfach unter:

http://www.ariva.de/forum/Schach-Thread-Provisorium-463012

Wir können sofort starten ......

Aber davon abgesehen, verstehe ich immer noch nur halb Deine Motivation. Oder hast Du in Deinem Job schlicht Zeit über und verbringst die eben hier. Ich meine, andererseits scheinst Du ja auch wirklich zu handeln etc. Sehr schwierig zu verstehen. Wie bistDu z.B. in den Precise Thread geraten. Denn Du denkst ja scheinbar, dass dort hauptsächlich ahnungslose, in Schrott Investierte Anfänger miteinander plauschen. Und die musst Du dann mal wachrütteln. Irgendwie so?

muss nicht immer eine motivation dahinterstecken,ich bin Freiberufler,konstruiere von zuhause aus und habe viel Zeit (an der börse verdiene ich mittlerweile aber meinen Hauptlebensunterhalt) Threads wie Genta ,YRCW oder Precise mache ich just for fun nebenbei,ich gerate zufällig in diese Threads. Mein spezielles Interesse ist aber die Smartcard,denn da gab es vor 13 Jahren einen gewissen Daniel Bland mit seiner Company "Upgrade international"(UPGD) ,die hatten eine Smartcard mit ausziehbarem "Shim" speicher entwickelt,die aktie stieg von 0,20 auf 90 Dollar,dann wieder runter auf null,heute delistet. Du kannst dir nicht vorstellen,was wir für einen spass mit den Longs in den "Upgrade Outlaw Foren" auf WO (Wallstreetonline.de) hatten ! Alles nachlesbar.

MFG
Chali

Ich will niemanden wachrütteln. Ganz im Gegenteil !!! Der spass wird erst dann am Grössten,wenn die Longs felsenfest von ihrem Investment überzeugt bleiben,auch wenn die Aktie über Monate und Jahre nur fällt !

Ich habe es life erlebt,was bei Upgrade und Microvision abgegangen ist ! Und Precise ist für mich genau diesselbe Liga ! Trotzdem wünsche ich unseren Longs nur das "Allerbeste" !

Du bist biotechanfänger und blickst nicht durch hast du gesagt. Vielleicht verstehst du etwas besser,warum ich solche Werte wie Lpath liebe ,wenn ich dir folgenden Chart von "Jazz Pharmaceuticals" zeige,einst auch eine Klitsche,aber nur eine zulassung und die 20.000% waren im Sack !!

The Company will hold a conference call on Wednesday, October 9, 2013, at 8:30 a.m. Eastern time to provide a status update to investors. Additional details regarding the conference call are set forth in the press release filed as Exhibit 99.1 to this Current Report, which is incorporated herein by reference.

neugierig was da veröffentlicht wird - wechsel der CRO (auf verlangen von pfitzer) sowie details zur ISONEP zukunft ... ?

finance.yahoo.com/news/...s-plans-isonep-option-203000327.html

Ich hoffe du bist noch dabei ,ich habe bei 4 dollar aufgestockt ! Die Phase-2 Results zu ISONEP kommen im 3.quartal 2014,solange müssen wir uns noch gedulden,aber dann ....

Lpath Announces New Antibody Program, Altepan™, Targeting Respiratory Disease
Anti-leukotriene antibodies were generated with ImmuneY2™, Lpath's drug-discovery engine
.....
SAN DIEGO, Nov. 21, 2013 /PRNewswire/ -- Lpath, Inc. (LPTN), the category leader in lipid-targeted therapeutics, has used its proprietary discovery technology to generate several monoclonal antibody product candidates targeting the leukotriene family of bioactive lipids. Leukotrienes are implicated in numerous inflammatory processes. The lead antibody, which binds to and neutralizes several different leukotriene isoforms, has shown positive in vivo results, and testing in animal models of respiratory disease, including asthma, is now underway.

"The scientific literature on the leukotriene pathway, coupled with our preliminary in vivo data, suggests that Lpath's approach of specifically targeting the bioactive lipid rather than the proteins themselves may have significant benefits over prior drug-discovery efforts in this area," said Gary Woodnutt, Ph.D., Lpath's senior vice president of research. "If the data continue to be positive and our preclinical development efforts are successful, we intend to file an IND sometime in late 2015."

Lpath's CEO, Scott Pancoast notes, "Our ImmuneY2 platform has again provided Lpath with a new promising program, underscoring the power and value of the technology. We look forward to updating investors on this and other advancements in the future."

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.

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

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

... keinen Kurs führt, daher Doppleposting:

Chalif, was sagst Du?
finance.yahoo.com/news/...trial-progress-poster-120000597.html