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Referencing the
NON-GENOTOXIC nature of kevetrin
http://www.bloomberg.com/apps/news?pid=newsarchive&sid=awU0FEEisNFA
Kevetrin is NONGENOTOXIC unlike the nutlins.
Article about cell cycle ,radiosensitivity,p53 interaction:
http://www.ncbi.nlm.nih.gov/pubmed/15234026
Kevetrin causes cell cycle arrest at the the G2/M phase of the cell cycle by decreasing CDK1 & cdc25, increasing Wee1 regulatory proteins, according to Dr Ashok Kumar in an old Cellceutix press release.
The G2/M phase of the cell cycle is the most radiosensitive portion of the cell cycle.
Preclinical studies using kevetrin with head and neck cancer corroborate this radiosensitizer effect of kevetrin :
http://cellceutix.com/cellceutix-announces-kevetrin-in-combination-with-radiation-delayed-tumor-growth-by-twofold-in-head-and-neck-cancer-study/#sthash.rOJ7ueQr.dpbs
I responded to Biodoc's post but should have responded to yours. The reason for oral cavity and oropharynx inclusion in the B-OM trial without other subsites of the head and neck is the drug Brilicidin -OM is given as a rinse. The only subsites in the head and neck region being coated and topically exposed to the rinse would be oral cavity and oropharynx head and neck sites. Other sites such as the nasopharynx,larynx,hypopharynx,sinuses etc are anatomically precluded from exposure to such a rinse -(exclusion of the lips is presumably because it might be difficult to achieve sustained contact with the lips during a rinse ).
I agree that the oral cavity and oropharynx cancers (especially oral cavity or with anterior extension to the oral cavity from the oropharynx) have a lot of problems with chemoradiation induced mucositis. However, the major reason these head and neck subsites were chosen is that Brilicicidin-OM is given as a rinse. This will allow the oral cavity and oropharynx to be coated with the drug. Other head and neck sites would not have direct contact with this drug especially given the way it is administered. There is likely a local/topical anti-inflammatory and antibacterial component to this drug mediating it's presumed effect on the oral mucosa.
This is interesting because Li-fraumemi syndrome treatment is another area of unmet need in which kevetrin might have utility. Also note that article indicates that CT scan alone was not adequate to evaluate response - disease was stable on CT but CT angiography showed decreased vascularity consistent with antiangiogenic effect . PETCT might better evaluate response to P53 therapies by showing decreased SUV reflecting nonviable tumor. Perhaps stable disease on CT scans of patients who were treated with kevetrin might reflect better response we realize .
Interesting article on compassionate use of a p53 treatment in patient with Li-fraumemi syndrome
http://m.mct.aacrjournals.org/content/6/5/1478.full
Article on p53 based therapies from Dr David Lane
http://m.cshperspectives.cshlp.org/content/2/9/a001222.full
Another article re quiet period
http://beginnersinvest.about.com/od/investingglossary/a/quiet_period.htm
Possible reasons for quiet period.
http://smallbusiness.chron.com/reasons-corporate-quiet-periods-20778.html
Thanks for sharing with us.
Xoc
Such Friday eve news would truely be unexpected by shorts and thus might magically destroy them, further prooving Leo's wizardary.
In days yore when only giants sailed CTIX IHUB seas, Leo would occasionally deliver a post trading hour or late day update. Although the days of the giants have faded into but distant memory, the magic has not left the realm. Leo can traverse dark FDA waters to deliver Brilicidin and soon Kevetrin from its murky depths. Will an update appear this eve from the mystic House of CELLCEUTIX, lifting bulls from despair sending shorts into the whirlpool of neverending woodofshouldhave couldhave?
How do we know that the update will occur before August? Leo stated in a response to a question from BK something like I Figure By Mid To Late July We Will Be Able To Update Shareholders (regarding FDA). This is not a promise and depends on FDA. I hope we do get this expected update, but FDA may delay.
I expect we will all be very happy ( except the shorts) by the end of the month. Even if reality does not match expectations this month, given all the potentially game changing oncologic , infectious, and antiinflammatory etc... drugs in the pipeline, I know we will soon be reaping the rewards of our faith in Cellceutix, it's pipeline and it's leaders/developers. Not only will we soon show marked financial gains, but even more importantly the world will benefit by becoming a healthier place to live.
I believe sjsa1 is a cell line not a subtype of osteosarcoma but that the p53 mdm2 interaction in this cell line reflects a likely benefit of kevetrin in similar osteosarcoma cells.
Expect a substantial price rise after uplist announcement as well as corporate update. http://www.thestreet.com/story/10723176/1/finding-uplist-clues-getting-in-before-prices-pop.html
Pardon the spelling, I meant to say specifically
The press release specufically mentions glioblastoma, a high grade glioma.
A press release indicated this activity for kevetrin in gliomas in 2012
http://cellceutix.com/cellceutix-adds-brain-cancer-to-growing-list-of-indications-for-its-novel-cancer-drug-2/#sthash.3yUp7A53.dpbs
The brilicidin-OM trial includes patients with cancers of the oral cavity and oropharynx and does not include cancers of the ,nasopharynx,hypopharynx,paranasal sinuses, unknown primary cancers etc. Therefore it will not be standard of care in all subsites of head and neck cancer. Assuming its efficacy is prooven, it will likely be used very frequently in cases where cancers extend to or treatment necessitates radiation directed towards oral cavity and oropharyngeal sites.
Current oral mucositis treatment includes BMX elixir (mixture of equal parts by volume benadryl elixir,maalox,2%
xylocaine) for pain relief, Gelclair to coat and soothe oral cavity, opiods at times. It can be quite debilitating,causing odynophagia and dysphagia (pain and difficulty swallowing), weight loss, need for feeding( PEG ) tube, dehydration, and other morbidity. Marked weight loss may require a new radiation treatment plan, taking time to plan the treatment and perhaps causing a break in treatment. If a treatment break occurs during chemoradiation it can potentially decrease the efficacy of the treatment. A good prophylactic therapy to prevent mucositis would likely make treatment more tolerable and perhaps even more successful if it prevents treatment breaks .
Of note leo responded as in my previous post to my question on 06/15.
Thanks BK, Leo is very excited about the potential GI applications of Brilacidin. I can see this both in his response to your questions and in his response to a recent query of my own about an old PR. LEO RESPONDED as below:
Last week I was traveling and I am now catching up on emails. At this time we are focused on Kevetrin and our defensin mimetics for creating additional applications. For example Brilacidin as an anti inflammatory would be a significantly greater market than as an antibiotic. Think GI diseases! Thats why we are anxiously waiting to see what happens in the OM trial.
Best,
Leo Ehrlich | CEO |
cellceutix
See my post 103339 regarding Leo's response to my question about potential utility of B-OM in other mucosal sites.
More information on Rbe2f tumor supressor pathway
https://www.dropbox.com/s/vkh5yg8wueh52s6/retinoblastoma.txt?dl=0
Inactivated protein is involved in the genesis of retinoblastoma ,however this pathway is also involved in devrlopmentof many other cancers and has many interactions with p53 pathway. Please see article below.
https://www.dropbox.com/s/yqyh07s72nf4c6y/1-s2.0-S1535610802001022-main.pdf?dl=0
Kevetrin also works on Rb-E2F pathway.
You may be right as well given the lethality of pancreatic cancer.
I agree that a blended trial design will decrease the number of patients and greatly decrease the time required to reach its endpoints. It will however expedite accrual by studying a relatively common cancer. This is true irregardless of the number of patients (which still may require substantial patient numbers) and time required for completion.
Lung cancer is the second most common cancer both in men and women, accounting for about 13 percent of all cancers. About 85% of lung cancers are non small cell lung cancers . Kevetrin had remarkable preclinical data( https://www.dropbox.com/s/pchjsscwuivm2bj/lung-cancer-NCI-H1975.pdf?dl=0) in non small cell cancers. Data in the current Phase 1 trial has been stated to be consistent with preclinical data. I predict that to obtain an adequate cohort of patients for a phase 1 trial blended into phase 2/3 trial, that given its frequency and good preclinical data ,that the cancer to be evaluated in the blended phase 1- 2/3 trial will be non small cell lung cancer, even given the previously announced response in an ovarian cancer patient.
ASCO may be A$CO for longs with press bound to pick up on this new possibility of blurred phases trial design and indication of effectiveness (validation of its promise by the Dana Farber IRB) of an oncologic drug esp given its release so close to ASCO. We have a potential game changer in Kevetrin.
I meant Sok
My name is Xoc but I am no Soc. Some readers may also mistake my posts for those of Soc.
Response from James Alexander /Leo indicating another potential use for Brilicidin compounds:to tx radiation induced cystitis and radiation induced proctitis. See my previous post for actual response.
I contacted Cellceutix and asked the following questions regarding potential additional uses of Brilicidin yesterday morning:
Formulations and trials are being worked upon and pending per press releases to treat inflammatory bowel disease - ulcerative proctitis and to prevent oral mucositis during radiation treatment for head and neck cancer.
I was wondering if topical Brilicidin formulations and trials have been considered to to treat radiation proctitis and vaginitis(suppository and cream respectively) during radiation therapy for genitourinary, gastrointestinal
and gynecologic malignancies?
I also was wondering if the B- OM formulation could also be considered for trials as a possible treatment for radiation esophagitis ( this would likely entail swallowing the formulation, presumably precluding it's use as a preventative compound)?
I received the following response from Jim Alexander.
Leo Erlich asked me to respond to your questions sent this AM.
We believe there is potential for brilacidin to have efficacy in prevention of radiation induced GU injury, as well as in radiation-induced proctitis. The upcoming study in oral mucositis prevention will inform us as to the potential for brilacidin in the conditions that you mention.
Thank you for your queries and interest.
Regards, Jim Alexander
W. James Alexander, MD, MPH
Chief Operating Officer
Cellceutix
RE: Prurisol:
In December 2014 , 5 months ago, Cellceutix announced FDA approval to proceed with Phase II trial for prurisol. Leo is the man. He advocates and expedites the advancement of the Cellceutix pipeline to maximize investor value. l would therefore assume that the trial would have started already UNLESS a deal was in the works, perhaps with another pharma. Perhaps he is waiting to announce such a deal after uplist.
ASCO abstracts will be available for perusal 05/13 @ 5 PM.
http://abstracts.asco.org/
http://www.the-lasik-directory.com/article_bacteria.html
Perhaps it could be used prophylactically after eye surgery see above