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ONCS press release hits the wires:
OncoSec Medical Presents Positive Immune Response Data from Phase II Study at the 8th World Congress of Melanoma
Data Confirms the Systemic Effects of DNA IL-12 Administered Locally with Electroporation
Jul. 22, 2013 / Updated: Monday, Jul. 22, 2013 06:14 AM
SAN DIEGO --
OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors, announced interim immune response data from the company’s Phase II study of ImmunoPulse in patients with metastatic melanoma. Findings showed that OncoSec’s ImmunoPulse demonstrated a significant change in tumor immunity following treatment with DNA IL-12 and electroporation. Dr. Adil Daud, principal investigator at the University of California San Francisco, presented the data at the 8th World Congress of Melanoma in Hamburg, Germany.
Blood samples taken at baseline (Day 1) and Day 90 from subjects treated with ImmunoPulse were analyzed. Changes in activated T-cells and regulatory T-cells were quantified. At Day 90 following treatment, it was demonstrated that there was a significant decrease in circulating “exhausted” CD8/PD-1+ (p=0.0017) and CD8/CD69+ (p=0.008) T-cells. PD-1 is expressed in activated exhausted T cells, and blocking PD-1 is an emerging treatment modality for multiple cancers including melanoma. These results demonstrate that plasmid delivery of interleukin-12 (IL-12) can also result in a decrease in exhausted T-cells, which may lead to improvement in clinical outcomes for patients treated with ImmunoPulse.
In addition to changes in circulating T-cells, an increase in NK cell frequency and activation was also observed from baseline. It was also demonstrated that antigen-specific T-cell responses to melanoma were increased with DNA IL-12 while other antibody responses were modulated and appeared to narrow over time. These data confirm the systemic effects of DNA IL-12 administered locally with electroporation.
Punit Dhillon, President and CEO of OncoSec, said: “We are encouraged by these immune data, since they highlight a potential mechanism of action for ImmunoPulse, and demonstrate the biologic activity of this therapy after only a single cycle of treatment.”
Dr. Daud commented: “The statistical significance of these data is impressive and confirms our understanding of the mechanism of action of IL-12. We look forward to understanding further if these changes in immune responses also correlate with positive clinical outcomes. These data will be shared later on this year.”
OncoSec recently announced completion of enrollment for its Phase II melanoma trial. Previously, the company announced that ImmunoPulse demonstrated clinical benefit in both locally treated and untreated distant melanoma lesions, and that the therapy appeared to be safe and well-tolerated, after an interim analysis of safety and efficacy of the first 13 patients.
About the Phase II ImmunoPulse Study
A total of 25 patients with stage III or IV cutaneous and in-transit metastatic melanoma have been enrolled in this Phase II, single-arm, open-label and multi-center study. The trial is designed to assess local and distant objective response following treatment of cutaneous melanoma lesions with DNA IL-12 and electroporation with a primary endpoint of 24 weeks. One treatment cycle consists of three treatments applied to up to four lesions on days 1, 5 and 8 with a maximum dose of 1.5 mg DNA IL-12 per treatment cycle. At 12 months, patients are moved to the follow-up phase of the study and will be followed for up to five years for safety.
About Melanoma
Melanoma is the most serious form of skin cancer. If it is recognized and treated early, it is almost always curable, but if it is not, the cancer can advance and spread to other parts of the body, where it becomes hard to treat and can be fatal. While it is not the most common of the skin cancers, it causes the most deaths. The American Cancer Society estimates that at present, about 123,000 new cases of melanoma in the US are diagnosed in a year, resulting in approximately 10,000 deaths. Melanoma originates in melanocytes, the cells that produce the pigment melanin that colors our skin, hair, and eyes. The majority of melanomas are black or brown, but often they can also be skin-colored, pink, red, purple, blue or white. Currently, there remain few treatment options for patients with late-stage metastatic disease that can extend survival for the broad population.
About OncoSec Medical Inc.
OncoSec Medical Inc. is a biopharmaceutical company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors. ImmunoPulse and NeoPulse therapies address an unmet medical need and represent a potential solution, for less invasive and less expensive therapies that are able to minimize detrimental effects resulting from currently available cancer treatments such as surgery, systemic chemotherapy or immunotherapy and other treatment alternatives. OncoSec Medical's core technology is based upon its proprietary use of an electroporation platform to enhance the delivery and uptake of a locally delivered DNA-based immunocytokine (ImmunoPulse) or chemotherapeutic agent (NeoPulse). Treatment of various solid cancers using these targeted anti-cancer agents has demonstrated selective destruction of cancerous cells while potentially sparing healthy normal tissues during early and late stage clinical trials. OncoSec's clinical programs include three Phase II clinical trials for ImmunoPulse targeting lethal skin cancers. More information is available at http://www.oncosec.com/.
This press release contains forward looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such "forward looking statements." Forward looking statements are based on management's current preliminary expectations and are subject to risks and uncertainties which may cause our results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include our ability to raise additional funding, our ability to acquire, develop or commercialize new products, uncertainties inherent in pre-clinical studies and clinical trials, unexpected new data, safety and technical issues, competition and market conditions. These and additional risks and uncertainties are more fully described in OncoSec Medical's filings with the Securities and Exchange Commission. Undue reliance should not be placed on forward looking statements which speak only as of the date they are made. OncoSec Medical disclaims any obligation to update any forward looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
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I emailed that exact question to the company a few weeks ago as they had promised an update on the trial. No response.
ONCS: company's electroporation tech is lisensed from INO. Hopefully the phase 2 results will show the same promise as the recent INO press release.
28 million dollar valuation for ONCS should correct nicely if phase 2 results show similar potential to INO.
Wish the company had been a littler less vague about the release date for these results. Hard to have a run-up if people don't know the exact date for news.
Congrats on a tight finish. And thanks SSkillz for yet another great contest.
What makes you so sure that the 4 million shares sold today are the entirety of the stock sales for the year? Don't you think it's possible that 4 million is all that they could sell at this point?
but, but, but, they said so last q......
That's better. Probably cash flow positive next quarter?
Earnings on the 13th. It's an easy 3 bagger if they top $1 million in revenue. Should be a clinical update released soon as well.
Perry Mason?
no freaking way this technology is going away
That's what they said about alchemy. GLTY.
Not really. Shorts make a market. In the case of AAA, no shorts = no one gives a rat's.....
Time to load up. Amazing to think a double from here just touches the .80 placements from last year.
So how much product did that impressed customer buy?
Any estimates on where the company is up to with patient entolment in the US?
DCTH
The PDUFA gets bumped 3 months but the advisory board is still going to weigh in on DCTH's application? Seems a bit odd....
The previously announced Oncologic Drugs Advisory Committee meeting remains unchanged, and the FDA will convene its ODAC Panel on Thursday, May 2, 2013 for review of the Company's NDA.
http://www.nytimes.com/2013/03/27/business/new-prostate-cancer-tests-may-supplement-psa-testing.html?ref=health&_r=0
HDVY is being left in the dust......
successfully sells over 400,000 gallons of in-spec FUEL made from TRASH at market prices...
So, ummm, how much money does that work out to per gallon?
.....maybe John could tweak machine number three so that it turns plastic into kool-aid....
John sure did communicate with shareholders: there was the tapes, the ship building dude, big Al in Flordia, dumps in Tennessee, the Mexican media credits, the enviro-friendly cleaning product biz, and the uplisting to the Nasdaq. (to name a few)
Then the SEC communicated with shareholders...........
Sort of like bragging about how clever you are for picking it just before a 50% haircut.
That's even more awesome. Except if you actually own it.
Hope you've been able to swing trade JBII over the years in your real portfolio. Certainly a lot of money to made selling that one and riding it back down with every operations update.
And the $64,000 answer is: would you believe anthing they said at this point?
You said it-you really are amazing! Imagine being so high up the ladder even after the week JBII had. I'm stuck at break even, trying to get out from under my resource picks.
Being back over a buck is a pretty hefty % increase from the current PPS. Hate to say it as I've been here for many years, but IMO, a buck is a long ways off.
There may be some bumps in the PPS with PRs and financing news, but barring a rotation of the spotlight and the money that follows it back into potash, AAA is going to have to keep grinding it out for the next 2-3 years.
Farhad has followed the plan and executed beautifully- nothing left to do but keep on keepin' on......and hope that the mining license is a cakewalk and the financing is indeed ready by June.
CC tidbits:
-The BFS builds in an extra year-
-first product in storage: 2015
-first shipment: 2016
-first revenue: "one year later"
-financing in the next "weeks and months" complete by the middle of the year
-At the present, "90 % of time (to be spent) on financing related activites"
-Permits: application end of this month, early next month for mining license
-Off takes: hoping to happen by the middle of this year "May-June of 2013"
After 4 years, what's another 5 months?
Agreed. In addition to the numerous hints about discussions with finance and off-take parties, there's the common sense reality of AAA claiming they'll be a producer in 2014. If you plan to produce in 2014, you don't wait until the end of Jan 2013 to start scaring up the financing.
Building up the infrastructure to be producing in 2014 will take time as well as money. I'm confident that Farhad has a solid, well advanced plan for the time and money needed to get the job done as forecast. To date, his predictions have been quite reliable.
I'm hopeful that these $$ discussions have been developing alongside completion of the FS, and hopefully, announcement of the successful completion of the 2 events will also happen at close to the same time.
Looking for a jump to a new floor this week. Hopefully enough to make the .80 buyers from the last 2 share sales happy.
AAA.TO .59
Feasibility Study due by the end of January....
CEO has stated he's not interested in dilution at the current PPS.
AAA plans to become a producer by 2014, so IMO negotiations to secure the necessary funding (off-takes) are well advanced and could be announced with the release of the FS or very soon thereafter. Potash has been taking in in the ash since its 2009 peak, but people need to eat and the sector will have its day again. When it does, AAA will easily exceed its previous highs of $2 +.
The project has a lot of support from the international community and the Ethiopian government with infrastructure projects underway to move and ship potash from Africa to India and China.
I missed the early load-up on MMT because of the NIgerian fear factor.
That won't happen here.
Sorry to mention it, but the merc hit 88 in Sydney today.
INO .72
Piper Jaffray chirps in "Overweight" on INO with a $1.00 price target.
http://www.streetinsider.com/New+Coverage/Piper+Jaffray+Starts+Inovio+Pharmaceuticals+%28INO%29+at+Overweight/8016998.html
And this piece trots out the number "$30 billion" in an INO article:
http://moneymorning.com/2013/01/17/meet-the-biotech-ceo-with-a-30-billion-breakthrough/
Excellent ground floor op for those with a 1-2 year investment plan IMO.
INO .67
Insider buy of 100k shares yesterday at .67
The shares are held in his kids/grandkids trust.
http://www.nasdaq.com/symbol/ino/insider-trades
jeeeez, maybe consider some meditation or medication to curb that aggression.
If you want picks that consist of $13.00 of volume at the bid of some illiquid POS, I can give them to you. Then you can win the $100 refund prize.
Thanks for the offer, but when I need $13, I'll just stick to JBII and SPIN.
With all due respect, 10 bagger funded the prizes for these contests out of his own pocket.
Only 2 of the 6 assistant mods for this board actually entered.
And when the guy who wins this thing 80% of the time isn't sharing his picks with the rest of us, it's hard for me to see this contest as an improvement.
and 10 bagger?
Cool. Thanks. Last question: Why did Upton veto the trade to the Mariners?
Soory to be a pain in the bacon but how about this scenario:
1. Stock A doubles and I sell it.
2. Stock B gains 0% and I sell it
Can I buy stock B again with the proceeds from stock A, essentially doubling my position in stock B?
Thanks,
2) If Stock A has 30k Imaginary Invested, and it doubles, then you want to sell it. The question is can you buy stock B with the proceeds. Based on the rules, you would think you could only buy an imaginary 30k worth. But I think Being able to keep trading a position to another position and keep making it bigger it a fun contest strategy, and has been a part of contest startegy for years. So I will continue to allow someone to trade stock A for Stock B regardless of how much stock A goes up or down. Hope this helps.
Does this rule include buying back a position that you've frozen, ie:
1. Stock A doubles and you freeze it.
2. 2 weeks later you buy stock A again.
3. Can the proceeds from the previous sale be used to re-acquire stock A?
And if that's the case, how does this not become a 1 stock-takes-all contest?
ie, I sell all 6 picks and use the entire cash position from all 6 sales to buy stock A.
Thanks
maybe even plays the viloin too....shucks Gomer, does everything but make money....
I guess there isn't a sucker born every minute after all.
it's hilarious to think that someone would spend even one thin dime on winning this contest....
Just Farhad coming through with the goods. Again.
I can't remember one single AAA PR that missed the mark the company set for itself, an extraordinairy achievement for a start-up.
Agri and potash companies are in the shiiter. Good timing. When the spotlight rotates back to this sector, AAA is gonna be looking fantastic. Numbnut analysts are gonna be "discovering" what longs here have known all along:
Great project, great management, great execution.
Can a couple of quarters of slack be given, in as much as these bumps in the road may result, especially in the case of the video technology, better prospects just ahead?
Slack is subjective. One investor's slack is another investor's falling knife, but based on the closing price today, I'd have to say the answer to your question is "no". Emphatically.
Let's not confuse SPIN with what it isn't: a large, established corporation with large, established revenues. When large, established corporations with large established revenues have bumps in the road, they may be allowed some slack.
Small, upstart OTC companies make bumps in the road look like sinkholes. And let's not forget that SPIN paved and mapped this road themselves. Many, many posts were made here lauding the good doctor for his overly conservative financial projections. Looks like he wasn't conservative enough.