Cleveland Biolabs (Nasdaq CLBI): FDA le scrive, lei risponde e cammina verso l'alto..

[alumnum]

Bio USA che recentemente ha superato delle resistenze piuttosto importanti con volumi e che potrebbe riservare un futuro interessante per via del loro prodotto che protegge i tessuti dalle radiazioni chemio....sembra che la FDA abbia da poco mostrato interesse...vediamo cosa accadrà....
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Cleveland Biolabs, a clinical-stage biotechnology company based out of Buffalo, NY (CBLI) with subsidiaries in Russia (covered later), has developed an anti-radiation drug CBLB502 (now known as Entolimod) which can be taken 24 hours before or even up to 48 hours after being exposed to a 70% lethal dose of radiation. A single dose of Entolimod increases survivability 300% -In June of 2012, the company announced survival results for its randomized, blind, placebo-controlled, efficacy study of Entolimod in 179 rhesus macaques. The animals had a survival rate of nearly three times the control group after a single dose of the drug. The treatment followed exposure to a 70% lethal dose of total body irradiation.

Also interesting to note that given no dose of Entolimod, the survival rate is 27.5% with survivability improving quickly to the 70-75% range with a single dose. This shows that the drug is having an effect and that it is not just random occurrence.CBLI stated in its June 2012 BioDefense update that Entolimod demonstrated increased survivability in animal models exposed to lethal radiation:

•3x survival of irradiated NHPs (Non-Human Primates)
•Significantly reduces incapacitation of survivors
•Reduces radiological damage in both HP and GI (gastrointestinal tract) systems
•Single intramuscular injection with broad application time window
• From prior (24 hr) to & post (>48 hr) exposure
•Completed two Phase I safety trials in total of 150 healthy volunteers
•cGMP drug product demonstrated stability at -20C for at least 4 years

Reviewing this, it is evident that Entolimod has a long storage life which is good if your going to stockpile and store the drug.

Timeline to Approval

It is going to take a lot of testing, time, funding and approval by the FDA before we see the drug released. The company is working towards the pivotal phase and has recently made progress towards this. Orphand drug status and Fast track status have been granted to Cleveland and should help towards speeding up the process by about 6 months. Per Cleveland:

CBLB502 (aka Entolimod) has been granted Fast Track and Orphan Drug status by the FDA. Due to the Fast Track designation of CBLB502, we are eligible to engage in early communications with the FDA and our BLA filing will be eligible for priority review, which could result in an abbreviated review time of six months. Due to the Orphan Drug designation, we may be eligible for a period of product exclusivity following approval of our BLA filing by the FDA.

 

[Sal.Vi]

2❤12&More(Frattali.Frattaglie.Frittate.F ranchige.Franchi.Futures.Féssy)

ticker probabilmente errato.

bio usa che recentemente ha superato delle resistenze piuttosto importanti con volumi e che potrebbe riservare un futuro interessante per via del loro prodotto che protegge i tessuti dalle radiazioni chemio....sembra che la fda abbia da poco mostrato interesse...vediamo cosa accadrà....
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cleveland biolabs, a clinical-stage biotechnology company based out of buffalo, ny (cbli) with subsidiaries in russia (covered later), has developed an anti-radiation drug cblb502 (now known as entolimod) which can be taken 24 hours before or even up to 48 hours after being exposed to a 70% lethal dose of radiation. A single dose of entolimod increases survivability 300% -in june of 2012, the company announced survival results for its randomized, blind, placebo-controlled, efficacy study of entolimod in 179 rhesus macaques. The animals had a survival rate of nearly three times the control group after a single dose of the drug. The treatment followed exposure to a 70% lethal dose of total body irradiation.

Also interesting to note that given no dose of entolimod, the survival rate is 27.5% with survivability improving quickly to the 70-75% range with a single dose. This shows that the drug is having an effect and that it is not just random occurrence.cbli stated in its june 2012 biodefense update that entolimod demonstrated increased survivability in animal models exposed to lethal radiation:

•3x survival of irradiated nhps (non-human primates)
•significantly reduces incapacitation of survivors
•reduces radiological damage in both hp and gi (gastrointestinal tract) systems
•single intramuscular injection with broad application time window
• from prior (24 hr) to & post (>48 hr) exposure
•completed two phase i safety trials in total of 150 healthy volunteers
•cgmp drug product demonstrated stability at -20c for at least 4 years

reviewing this, it is evident that entolimod has a long storage life which is good if your going to stockpile and store the drug.

Timeline to approval

it is going to take a lot of testing, time, funding and approval by the fda before we see the drug released. The company is working towards the pivotal phase and has recently made progress towards this. Orphand drug status and fast track status have been granted to cleveland and should help towards speeding up the process by about 6 months. Per cleveland:

Cblb502 (aka entolimod) has been granted fast track and orphan drug status by the fda. Due to the fast track designation of cblb502, we are eligible to engage in early communications with the fda and our bla filing will be eligible for priority review, which could result in an abbreviated review time of six months. Due to the orphan drug designation, we may be eligible for a period of product exclusivity following approval of our bla filing by the fda.

 

[Sal.Vi]

Bio2❤12&More(Frattali.Frattaglie.Fritt at e.Franchige.Franchi.Futures.Féssy)

►►C B L I◀◀

Cleveland BioLabs, Inc. (CBLI), incorporated on June 5, 2003, is a biotechnology company. CBLI is focused on developing biodefense, tissue protection and cancer treatment drugs based on the concept of modulation of cell death for therapeutic benefit. Its pipeline includes products from two primary families of compounds: protectans and curaxins. CBLI is developing protectans as drug candidates that protect healthy tissues from acute stresses, such as radiation, chemotherapy and ischemia. Curaxins are being developed by Incuron, LLC (Incuron), its subsidiary, as anticancer agents that could act as mono-therapy drugs or in combination with other existing anticancer therapies. As of December 31, 1010, the Company’s products in development included Protectans, Protectan CBLB502, Protectan CBLB612, Curaxins, Curaxin CBLC102 and Other Curaxins. As on January 20, 2011, CBLI owned 76% interest in Incuron, LLC (Incuron).

Protectans

CBLI is exploring a natural source of factors that temporarily suppress the programmed cell death (apoptosis) response in human cells, which can be rapidly developed into therapeutic products. These inhibitors, known as protectans, are anti-apoptotic factors developed by microorganisms of human microflora throughout millions of years of co-evolution with mammalian hosts. It has established a technological process for screening of these factors and their preclinical evaluation.

Protectan CBLB502

Protectan CBLB502 is its leading radioprotectant molecule in the protectans family. Protectan CBLB502 represents derivative of the microbial protein, flagellin. Flagellin is secreted by Salmonella typhimurium and many other Gram-negative bacteria, and in nature, arranges itself in a hollow cylinder to form the filament in bacterial flagellum and acts as a natural activator of nuclear factor-kappa B (NF-kB). Protectan CBLB502 is a single agent, anti-radiation therapy with demonstrated survival benefits at a single dose in animal models. Its scientists have demonstrated that injecting Protectan CBLB502 into mice, rats and non-human primates protects them from lethal doses of total body gamma radiation.

In January 2010, the Company began dosing in the second human safety study, a Phase Ib study, for Protectan CBLB502 and completed dosing in May 2010. Protectan CBLB502 is being developed under the United States Food and Drug Administration’s (FDA’s) animal efficacy rule to treat radiation injury following exposure to radiation from nuclear or radiological weapons, or from nuclear accident. Protectan CBLB502 was granted fast track status by the FDA in July 2010. Protectan CBLB502 was also granted orphan drug status by the FDA in November 2010.

Protectan CBLB612

The Company has conducted some preliminary research into a compound derived from the protectan family and, which CBLI refer to as Protectan CBLB612. Protectan CBLB612 is a modified lipopeptide mycoplasma that acts as a stimulator and mobilizer of hematopoietic (bone marrow/blood production) stem cells (HSC) to peripheral blood. As of December 31, 2010, Adult hematological bone marrow stem cell transplantation was used for hematological disorders (malignant and non-malignant), as well as some non-hematological diseases, such as breast cancer, testicular cancer, neuroblastoma, ovarian cancer, severe combined immune deficiency, wiskott-aldrich syndrome and chediak-higashi syndrome.

Curaxins

Curaxins are small molecules that are intended to destroy tumor cells by simultaneously targeting two regulators of apoptosis. Its initial test results indicate that curaxins may be effective against a number of malignancies, including RCC, soft-tissue sarcoma, and hormone-refractory prostate cancer. It has established a drug discovery program to identify small molecules that selectively destroy tumor cells.

Curaxin CBLC102

One of the curaxins from the 9-aminoacridine group is a long-known, anti-infective compound known as quinacrine, which the Company refers to as Curaxin CBLC102. It has been used to treat malaria, osteoarthritis and autoimmune disorders. The Company has discovered mechanisms of action for quinacrine in the area of apoptosis. Curaxin CBLC102 has pharmacological and toxicological profiles and demonstrates the anticancer effect in transplants of human cancer cells into primates. In November 2010, the first patient was dosed in a multi-center clinical trial of Curaxin CBLC102 on patients with liver tumors in the Russian Federation.

Other Curaxins

The Company has developed Curaxin CBLC137, which is a drug candidate with composition of matter belonging to its next generation of curaxins. Curaxin CBLC137 has demonstrated anti-tumor effects in animal models of colon, breast, renal and prostate cancers. Curaxin CBLC137 has favorable pharmacological characteristics, is suitable for oral administration and demonstrates a complete lack of genotoxicity.

The Company competes with RxBio, Inc., Exponential Biotherapies Inc., Osiris Therapeutics, Inc., ImmuneRegen BioSciences, Inc., Neumedicines, Inc., Cellerant Therapeutics, Onconova Therapeutics, Inc., Araim Pharmaceuticals, Inc., EVA Pharmaceuticals, Terapio, Aeolus Pharmaceuticals, Cangene Corporation, Humanetics Corporation, Genzyme Corporation and Bayer HealthCare Pharmaceuticals Inc.

Il presente post non ha valore per l'operatività stretta (frames brevi: settimanale o meno); al più, ha utilità di tipo strutturale, al fine di meglio comprendere l'evoluzione prezzi della company.
I hope at least minimally useful. In case of interest (€uribor free, but spread for ever) ►►►►►►►.


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[cervellofine]

Hanno avviato la copertura sul titolo ben due case d'investimento nell'ultimo mese dell'anno appena trascorso, c è da fidarsi? Target 3,00 dollari, supporto 1,20..Ciao

 

[the volture]

sono entrato a 1,92..molto combattuto,con stop rigido...voglio dargli fiducia per domani,se fa come potrei pensare

 

[the volture]

uscito a 2.25