Farmas USA

NVIV

Esta ha empezado a cotizar en el Nasdaq hace poco y por lo pronto es mi sustituta para OCAT. Tiene un implante tipo andamio de células madre que se coloca en la columna y parece devuelve el movimiento a los paralíticos, invento de Langer, otro de los gurús de las células al que ayer o anteayer la Reina de Inglaterra concedió no sé qué medalla o premio; está cargado de reconocimientos el tío. Es muy mediática, de culto ya, y la sigue Napodano. Ya lleva tres pacientes en los que funciona y la FDA acaba de dar el visto bueno para ampliar el estudio. El próximo paso es pasar de pivotal study a benefit study. El pivotal empezará en 2016.

La información del informe trimestral es la siguiente.

The pilot study was initially approved for five subjects in up to six clinical sites across the United States, and as of October 2014, the number of allowable clinical sites was expanded to up to 20. We currently have 14 clinical sites open. In October 2015, the FDA approved an expansion of the study to permit enrollment of up to 10 subjects.

At September 30, 2015, we had cash of approximately $22,146.

We enrolled the last two patients of the planned five-patient pilot study and announced an AIS conversion in the third patient with a high thoracic injury at one month, which occurs less than four percent of the time. We also announced plans to transition the pilot study into a pivotal probable benefit study and use this single study as the basis for a Humanitarian Device Exemption application.

We have fostered a collaborative relationship with the FDA, and we are optimistic that we will finalize the pivotal probable benefit study design in the coming months. Assuming that we receive FDA approval, we currently expect the pivotal study will begin in 2016, with estimated completion in 2017, which depending upon the results of the study could enable us to obtain FDA approval to commence commercialization under a HDE

Napodano: has $22M in cash and burns only $900k per month. Fears over the cash position are misguided

La base del invento tiene sentido

https://www.youtube.com/watch?v=3AleKb5ytbg

I think I might need to buy some invivo. Trials are already being designed to utilize a 3 prong approach with scaffolding, stem cells, and implanted stim device to promote axonal regeneration
Pretty incredible. ~10% of these "complete" patients recover some functionality so having only the first patient respond so positively was great but not strong proof that the scaffold works. Now having the first 2 patients respond puts very strong odds on the scaffold working..
Simple statistics says 1 patient recovering movement is 1 in 10 chance of spontaneous recovery. The first 2 patients recovering movement would then be a 1 in 100 chance that it is spontaneous recovery (and not the scaffold)

23-10-2015
provides 12-month post-implant update for the first study patient in its ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with complete acute spinal cord injury (NVIV) : In the time between the 6-month and 12-month post-injury assessments, the patient continued to demonstrate improvement in the American Spinal Injury Association (ASIA) lower extremity motor score with an additional 8 points gained on this 50 point score. The patient demonstrated additional bilateral improvements in the motor function of hip flexors and knee extensors and flexors.
A large natural history database shows that patients with similar level injuries (T10-T12) have an average increase of lower extremity motor scores between 6 and 12 months of fewer than 2 points.

10-10-2015
(FDA) has approved the expansion of the number of patients from five to ten in the company’s pilot study of its investigational Neuro-Spinal Scaffold™ implant in patients with acute thoracic spinal cord injury. As previously communicated, InVivo intends to transition the pilot study into a pivotal probable benefit study and to use this single study as the basis for a Humanitarian Device Exemption (HDE) application.

6-7-2015

InVivo Therapeutics Reports Significant Improvement of Second and Third Patients Implanted with Neuro-Spinal Scaffold
http://www.invivotherapeutics.com/press-releases/invivo-therapeutics-reports-significant-improvement-of-second-and-third-patients-implanted-with-neuro-spinal-scaffold/

30-6-2015
Rutgers New Jersey Medical School in Newark, NJ has been added as a clinical site in the company’s ongoing pilot study of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury (SCI). Robert Heary, M.D., Professor of Neurological Surgery and Director of the Spine Center, has been named Principal Investigator at this site. The Spine Center is part of the Northern New Jersey Spinal Cord Injury System, one of 14 federally designated Spinal Cord Injury Model Systems in the United States and the only one in the state of New Jersey.

Mark Perrin, InVivo’s CEO and Chairman, said, “We are pleased to welcome Dr. Heary and the New Jersey Medical School into InVivo’s ongoing pilot study. Having a Spinal Cord Injury Model System Center as part of our trial will be beneficial as we look to enroll the final two patients in our ongoing study.”

There are currently 12 clinical sites that are open for enrollment:

This is the company’s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The Investigational Device Exemption (IDE) pilot study has been approved by the FDA and is intended to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. Following the pilot trial, InVivo expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption (HDE).

29-6-2015
InVivo Therapeutics is Added to Russell Global, Russell 3000®, Russell 2000®, and Russell Microcap® Indexes | InVivo Therapeutics

InVivo Therapeutics secures expanded patent for Neuro-Spinal Scaffold ? 5 quick notes
Bob Langer, MD, is first inventor on the patent applications, and one of 11 professors at MIT to be awarded both the United States National Medical of Service and the United States National Medal of Technology and Innovation.

19-2-2015

Paciente que anda tras operación en la columna
From his parents blog on jordan's road to recovery after having procedure performed on spine..

InVivo Enacts 1-for-4 reverse stock split - 4/8/15

Sí, la nueva moda es que las acciones más odiadas están pasando a cotizar también en la bolsa israelí. Después de unos días vuelven a caer. Han salido varios artículos al respecto alertando del tema. También ha entrado en el índice BTX y NAVB.

NVAX

En relación al tema de las pruebas y el partner en Europa para el RSV Stan dijo el el CC del pasado agosto cuando le preguntaron dónde iban a hacer pruebas además de en USA que:
"Primero querían iniciar la Fase 3 en USA y luego extender el estudio a Europa solicitándolo a la EMEA a lo largo del próximo año"

Aquí está el texto.

Okay. And do you have any indication of whether you’re making a global study versus just US?

Stanley Erck - President and CEO
What we are looking for quarter – what we are looking for is to have the pivotal Phase 3 data generated from this trial in the U.S. this year, and as we think about expanding our license share into the EMEA, we can do a European trial study next year some time.

Yo tengo una conclusión clara al respecto de extender el estudio a Europa. Stan ha dicho en más de una ocasión que se planteaban buscar un partner para Europa y mantener la independencia en USA. Si tienen previsto el ensayo en Europa para el próximo año una de dos, o tienen un partner ya muy avanzado o la empresa va a ser adquirida y el comprador no quiere un partner aquí porque ya tiene presencia en Europa y no quiere ceder futuros ingresos.

Yo particularmente me decanto por lo segundo. Si Pfizer (por poner el ejemplo de siempre) adquiere Novavax no quiere que esta tenga un socio en Europa. Por eso creo yo que aún no se ha anunciado un Partnership.

Si Novavax de verdad quiere seguir de manera independiente un partner potente sería la solución. Una inyección enorme de dinero a cambio de ceder parte de los futuros ingresos y el apoyo de una Big Pharma. Eso dispararía la cotización y lanzaría un claro mensaje al mercado y a la industria.

Yo creo que antes de final de año vamos a tener la solución a este asunto. Anunció de partnership o....

ATHX

Esta es otra que me gusta relativamente. Lo de las células para infarto creo que funciona, pero veo difícil que en condiciones normales se puedan crear y administrar células autólogas en menos de 36 horas, que es lo que necesitan para el ensayo.

El gran problema que tienen es el diseño de los ensayos, que siempre los hacen mal. En cualquier caso, el producto es interesante, los japos van detrás; a los precios actuales le veo bastante potencial.

Hasta marzo en principio no creo que se casquen dilución. Suelen hacerla cuando les quedan 20 kilos, pero la anterior la hicieron en enero. Por andar seguros, hasta enero nos da tiempo de tradearla sin problemas.

Datos del informe trimestral

we had $28.5 million in cash and cash equivalents compared to $26.1 million at December 31, 2014. During the third quarter of 2015, cash used in operating activities was $3.7 million compared to cash used in operating activities of $6.2 million in the third quarter of 2014.

- Ischemic stroke: over the past few months, we have continued to analyze the data from this study, and we believe that the results demonstrates that administration of MultiStem provides substantial benefits to patients that have suffered a debilitating stroke. administration of MultiStem within 36 hours of the occurrence of the stroke is associated with substantial improvement across each of five important areas that together comprised what might be regarded as an optimal outcome for these types of patients. These five metrics includes the following.

Achieving good or excellent recovery in each of the commonly accepted clinical rating scales used in these types of studies including the Modified Rankin Scale, which assesses global disability, the NIH Stroke Scale, which evaluates cognitive and motor scale deficits, and the Barthel Index, which accessed the patients' ability to independently performance activates of daily living such as feeding, grooming, bathing, use of the toilet, and other functions that we generally all take for granted, and no occurrence of life-threatening adverse events for mortality, and the absence of secondary infections that can prolonged hospitalization and impede patient recovery.

When we evaluate patient recovery through this lens, the data showed that administration of MultiStem within 36 hours is strongly associated with better patient recovery. In particular, the data show that a substantially higher percentage of patients achieve recovery across each of these pre-specified clinical metrics when compared with patients receiving current standard of care, approximately 41% of MultiStem treated patients versus only 11.5% of placebo treated patients. this particular metric was not a pre-specified end point for the study
data reflect that patients treated with MultiStem within 36 hours show a clear and consistent pattern of better recovery at day seven, day 30 and day 90 post stroke, as evidenced by robust and statistically significant differences in each of the individual clinical scales, as well as in the modified Rankin shift analysis, which is another commonly utilized and pre-specified end point used in this study. biomarker data provides clear evidence that the administration of MultiStem is associated with a substantial and statistically significant reduction in inflammatory immune cells and inflammatory cytokines in the days following the stroke. This reduction in the inflammatory cascade is even more pronounced when we assess the patients that received earlier treatment with MultiStem within the 36-hour window

Under the new system will require evidence of safety and efficacy from Japanese patients in clinical institutions, in addition to data from the international study we were conducting.

In our earliest discussions, we explored whether we might expand the ongoing Phase II trial to possibly include clinical sites in Japan in an effort to utilize the new framework. As we've described previously, however, it became clear that we would have had to delay of completion of the study in order to achieve an appropriate level of enrollment in Japan, which we were reluctant to do. So, as an alternative, we discussed with PMDA the possibility that we would complete the ongoing international trial first, evaluate the result of the study, and then use those results to guide our subsequent clinical development efforts. We would then meet with PMDA to brief them and submit our detailed plan for an additional study in Japan

We are now focused on completing relevant diligence and other activities with our new prospective partner so that we may formalize this partnership and move forward accordingly, including working with PMDA to define the next phase of clinical development in Japan. Obviously there are no guarantees in that regard, we would expect to formalize and announce this partnership over the next several months, likely sometime early next year.
outside of Japan. We are currently engaged in multiple discussions with potential partners around our stroke program, as well as in other areas

- In the cardiovascular area, our current focus is on advancing our ongoing Phase II clinical trial evaluating the administration of MultiStem to patients that have suffered substantial damage from an acute myocardial infarction. In the past few months, we have added additional clinical sites in accordance with our clinical plan as we continue to work toward our goal of completing enrollment as efficiently as possible and reporting top line results sometime in the latter part of next year.
study is funded in part with a grant awarded from the National Institutes of Health. This study will evaluate patient recovery using well-established clinical metrics, including using MRI to assess heart function, with a primary efficacy assessment in 120 days post-treatment, including evaluating incidence and severity of adverse events, as well as assessing major adverse cardiovascular events, or MACE, up to one year post-treatment.

- In the pulmonary area, in the past quarter, we successfully obtained regulatory authorization in both the US and in the UK to conduct our trial evaluating the administration of MultiStem to patients that are suffering from ARDS, or acute respiratory distress syndrome. We believe that administration of MultiStem in the early phase of ARDS, could reduce the inflammatory complications associated with the condition. We are now in the process of launching this trial and expect to initiate patient enrollment soon

Células

Esto, que como he hablado de "sustituta" de OCAT, creo que no está de más de comente que ninguna de las empresas que acabo de postear es ni remotamente comparable a ella en cuanto a propiedad intelectual, pipeline y seriedad investigadora. Digamos que, de las que hay, son a las que más opciones les veo en este momento, junto a CYTX y, sobre todo las TIG (pero mi broker no me deja comprarlas), dado que se calienta el sector.

Vaya con las MNKD, vaya un juego que se traen, veremos como acaba.

Mugi, ¿Sabes qué me da miedo de ARRY? Que se vaya a cerrar gap a los 4$.... Está al borde del pequeño precipicio...
La iré siguiendo con mucha atención, como de costumbre...

Un saludo y suerte

ARRY

Gran información, gracias!!!!!
Aunque acojonado sigo

GALE