Farmas USA

El tema, como siempre, está en vender, o no vender, en qué nivel vender, o aguantar.....
Ahora +2,35% en pre y +13,5% en mi cartera....
Las IMMU ya las tuve aún mejor, y luego se desincharon....
Difícil, difícil....

GALE

CLSN

Yo. Fue mi primer batacazo nada más empezar y lo guardo de recuerdo. En principio tienen cash hasta el segundo trimestre de 2016, pero el día 19 del mes pasado aprobaron en junta una dilución y ya han sacado el S3:

APPROVAL OF THE ISSUANCE OF SHARES OF COMMON STOCK IN RELATION TO THE EARNOUT PAYMENTS OF UP TO $30.4 MILLION THAT MAY BECOME PAYABLE IN THE FUTURE IN CONNECTION WITH THE ACQUISITION OF ASSETS OF EGEN

Te pego el resto de datos nuevos que tengo por ahí

Publication of Preclinical Data Demonstrating Lung Specific Delivery of microRNA-145 Inhibitor Using Its Novel TheraSilence™ Platform
Treatment Led to Normalization of Cardiovascular Function in Model of Pulmonary Arterial Hypertension
http://investor.celsion.com/releaseDetail.cfm?ReleaseID=913407

29-4-2015
Celsion Expands Clinical Development Plan for GEN-1 IL-12 Immunotherapy Program in Ovarian Cancer
Programación fase 1 GEN 1 + avastatin + Doxil para el tercer trimestre
The Company announced plans today to expand its ovarian cancer development program to include a Phase 1 dose escalating trial evaluating GEN-1 in combination with Avastin® and Doxil® in platinum-resistant ovarian cancer patients, expected to begin in the second half of 2015. As previously reported, Celsion intends to commence a Phase 1b dose escalating trial in newly diagnosed ovarian cancer patients in the third quarter of this year.
Celsion intends to conduct additional preclinical studies to support an Investigational New Drug filing with the U.S. Food and Drug Administration for the planned Phase 1 combination study. The study will be designed to optimize the dosing regimen for GEN-1 in combination with Avastin® and is expected to enroll approximately 12 to 18 patients
The results of this important trial may therefore highlight additional therapeutic opportunities for GEN-1 and help guide how our development program evolves over the long term. We look forward to launching our study in first line ovarian cancer this year, followed by the launch of this combination trial, and then moving into clinical studies in a second tumor type, glioblastoma multiforme where Avastin® is currently used."
http://investor.celsion.com/releaseDetail.cfm?ReleaseID=909402
6-1-2015
Presenta protocolo de ensayo de fase I a la FDA: inmunoterapia GEN-1 para pacientes con cáncer ovárico en tratamiento con quimio.
http://www.streetinsider.com/Corporate+News/Celsion+%28CLSN%29+Submits+GEN-1+Phase+1+Clinical+Protocol+to+FDA/10139540.html?si_client=intbro

12-11-2014 Informe trimestral
our registrational Phase III OPTIMA study is progressing very, very well. We are now recruiting patients in key markets in the Asia Pacific region and will be aggressively adding important clinical sites in Europe, North America and Taiwan in the fourth quarter as planned.
Our clinical trial application for China was filed last April. And with very positive face-to-face interactions with the China FDA, we expect CFDA clearance of the OPTIMA study in early 2015, a timeline appearing to be about 10 to 11 months
we are preparing to advance ThermoDox into a European base study in recurrent chest wall breast cancer. This is a trial that has been inspired by the U.S. DIGNITY program. This program is made up of a series of small trials that have shown impressive findings, but have been extremely difficult to enroll.
also preparing to advance our first immunotherapy candidate GEN-1 (we formerly referred to as EGEN-001 frankly I find GEN-1 easier to present) into a study to more fully establish the relationship between the activation of cellular immunity and combined with the standard of care and efficacy in first line ovarian cancer patients.
we plan to advance GEN-1 into a second indication. While they could very well become the priority for the company and that’s in glioblastoma multi form of GBM or more commonly known as brain cancer. Our plan is to file an IND for Phase I study in this indication in the second quarter of 2015.
we enrolled our first patient in our Phase III OPTIMA trial in primary liver cancer, also known as HCC or hepatocellular carcinoma. The study will enroll approximately 550 patients globally and up to 100 sites in North America, Europe, China and Asia Pacific. It is a two-arm, double-blinded randomized study comparing ThermoDox in combination with sRFA, standardized to a minimum of 45 minutes across all investigators in the study versus sRFA alone.
OPTIMA is designed and powered base in our learnings from the 700 patient HEAT study, which shows clearly that RFA when used within its design limitations has a much better effect in patients with a 3 centimeter lesions or greater. Larger tumors require more time, this we learnt. Our assessment is a minimum of 45 minutes is required for an optimal outcome.
Post-hoc findings and hypothesis supporting OPTIMA do not represent our view alone. is a great deal of optimism for the OPTIMA study among virtually all of the most important names in HCC research worldwide

As of June 30, 2014 and a sub group of 285 patients who received sRFA treatment, 285 patients represents approximately 41% of the total 700 patient studies. In that cohort we noted a 57% risk improvement in overall survival in the ThermoDox plus standardized RFA arm versus standardized RFA alone, and improved and established repeatedly and consistently over the past seven quarters, consistently with high confidence and most recently with the p-value of 0.037.
A 57% risk improvement versus sRFA alone is an extremely meaningful outcome in this historically deadly cancer, where median survival outside of the HEAT study was a relatively short 30 months.
will note however, that median survival data has improved some with their approval of Nexavar or sorafenib. But it hasn’t been by much. And well, there should be some caution since this is a retrospective analysis and as we said multiple times.
cash usage over the first three quarters of 2014 has been $1.6 million per month, and is estimated to reach approximately $2 million per month with the full implementation of the OPTIMA study, and the integration and clinical development of the newly acquired assets from EGEN.
Our current cash is projected to carry us well into the second half of 2014
" I would like to ask you to make one correct first, you report the statement of 2014 and 2016.
Jeffrey Church - SVP, CFO and Corporate Secretary

I’m sorry. Yes, I’d mentioned that occurring cash is projected to take us well into the second half of 2016"
http://seekingalpha.com/article/2672025-celsions-clsn-ceo-michael-tardugno-on-q3-2014-results-earnings-call-transcript?page=7&p=qanda&l=last

OCAT

Por cierto, que hace mucho tiempo que esperábamos que sacaran los datos de lupus y Chron. Va a haber mucha alegría, en el foro al menos. Dado que se han centrado en el ojo, es posible que el partner llegue por aquí, aunque es muy pronto.

Los datos seguramente son los de perros, pero hay que tener en cuenta que se han tratado con células humanas.

Dogs get diseases very similar to us humans. These are live animals with sophisticated immune systems so they're ideal to look at some of these autoimmune disorders. German Shepherds for instance do get a disease known as anal furunculosis. This is an analog of Crohn's disease. We went into these dogs that were resistant to conventional therapy, which normally would entail the use of cyclosporin and other powerful immunosuppressive drugs, but they were resistant even to those conventional therapies. We went into six of these dogs and all six of those dogs went into complete remission.<\b>

15. So that's just one autoimmune disease, but in humans there are over 100 autoimmune diseases. In addition to multiple sclerosis and lupus, there is osteoarthritis, diabetes, the list goes on and on. In addition, we know that these cells are likely to have an impact on other diseases such as kidney failure or liver failure, or even pulmonary, so there are a lot of applications that you could use these cells for. In addition, these are immune modulated cells, so you don't have to worry about immune rejection. You can just use them off the shelf."

Mi 2ª mayor perdida ... sucedida una buena noche en un after hour apocaliptico de esos que te quitan el sueño .... ain ...

CLSN

En cuanto al lupus, también tenemos ahí a IMMU, con el EPRATUZUMAB en Fase III..

IMMU

RNN, una que había perdido el lateral, +24% en pre, con la concesión de una patente en Japón...
A ver si pasa lo mismo con las DMPI antes de septiembre...

Un saludo

Me uno al club de los apocalipsis.

Mi trío de ases son AMRN, MACK y CLSN aunque tengo muchas más pero estas tres hacen que las demás parezcan de risa. Lecciones que aprende uno en este mundillo...

Uf, pues yo, si miro años para atrás, desde 2007/2008, habría algunas, sobre todo, OTC y esas que parecía que ibas a doblar en un plis plas...
Hablo de DLAD, MESA, DKGR, y algunas perlas cultivadas más...
La más reciente, SBFM, que me ha pillado un buen pellizco...
Pero sigo manenienndo la esperanza de recueprar el año que viene...
Las LLBO, me pillaron, pero he recperado una buena parte, y veremos a final de año si he conseguido recuperarlo todo...

Un saludo...tengo que salir a una asistencia... a ver si a la vuelta me encuentro con alegrías....