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Anavex worthy of their market cap?
Hope Missling did not force you to buy like Punit did.
no need to blame companies for your own investor decisions. I have yet to come across a CEO who forces somebody to buy shares.
Dont't miss out on Tap.
you did not hold on to your initial buy around the .30 ?
Thanks for the background!
There was a webinar earlier in the year. I presume this goes with being Nasdaq listed.
It's loadup time!
nice bounce today.
I have seen many of these conferences come and go.
But i hope you are right!
I like your optimism. Please explain why this one will trigger MAJOR buying?
Nothing has been said by Anavex about doing a RS. In fact I would be surprised if they did. They have the stuff to do it organically and dr Missling knows that.
Parkison is still subject to pre-clinical work with Lundgren
As for epilepsy, having 13mil, is that sufficient for a p2?
Please show were this is claimed in the pr
Please point me to the word spectacular in this PR.
It is not in it, so stick to facts please!
OncoSec Announces Positive Results from Phase II Trial of ImmunoPulseâ„¢ IL-12 in Merkel Cell Carcinoma
DOWNLOAD AS PDF
SEPTEMBER 27, 2015
SAN DIEGO, Sept. 27, 2015 /PRNewswire/ -- OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today announced results from a Phase II trial demonstrating that its investigational therapy, ImmunoPulseâ„¢ IL-12, promotes tumor-specific, systemic anti-tumor immune responses in patients with Merkel cell carcinoma (MCC). Shailender Bhatia, MD, Assistant Professor of Medicine, Division of Medical Oncology at the University of Washington School of Medicine and Principal Investigator of the trial, presented the findings today in an oral presentation at the 2015 European Cancer Congress in Vienna, Austria.
"The successful completion of the first prospective trial of immunotherapy in MCC marks an important milestone," said Dr. Bhatia. "Importantly, our findings support the hypothesis that intratumoral IL-12 DNA with electroporation promotes tumor immunogenicity. The results confirm the potential of this approach to make a clinically meaningful impact on patient outcomes for this virus-associated cancer."
In this Phase II study, 79% of patients (11/14) showed an increase in IL-12 protein levels in tumor biopsy samples obtained approximately 22 days after treatment compared to baseline, indicating that ImmunoPulseâ„¢ IL-12 leads to successful DNA transfection and sustained protein expression within the tumor microenvironment. ImmunoPulseâ„¢ IL-12 was well-tolerated, with no treatment-related adverse events above Grade 2 and no treatment-related serious adverse events. The most common adverse event was Grade 1 transient pain associated with the treatment procedure.
Analysis of individual lesions found that 30% of patients (3/10) who were evaluable for systemic anti-tumor immunity had regression of at least one distant, non-injected/non-electroporated lesion. In patients considered evaluable for objective response by modified RECIST criteria (i.e., Cohort B, N=12), 25% of patients (3/12) had an objective partial response (PR) and one patient had stable disease (SD) for a disease control rate (PR + SD) of 33%. In Cohort A (N=3), one patient had a pathologic complete response and continues to be recurrence-free at six months. Another patient has been recurrence-free for over three years. Immune correlative data suggest that ImmunoPulseâ„¢ IL-12 can increase tumor-infiltrating lymphocytes and may promote a tumor-specific CD8+ T-cell response.
"We are very excited to observe that ImmunoPulseâ„¢ IL-12 continues to demonstrate that intratumoral treatment with IL-12 DNA and electroporation can induce anti-tumor immune effects both locally and systemically," said Mai H. Le, MD, Chief Medical Officer at OncoSec. "These results are consistent with what we have previously observed in metastatic melanoma and underscore the broad-reaching potential of ImmunoPulseâ„¢ IL-12 in driving immunogenicity."
About the Phase II Study Design
OMS-I110 was a Phase II open-label study that enrolled 15 patients with MCC. The primary endpoint of the trial was IL-12 protein expression following treatment with ImmunoPulseâ„¢ IL-12. Secondary endpoints included: safety and tolerability; overall response rate evaluated by RECIST-modified criteria for MCC; distant lesion regression; and biological markers of pro-inflammatory changes in the tumor microenvironment. Modifications to the standard RECIST criteria included permitting more than two measurable lesions per organ (e.g., skin) to be considered evaluable as "target lesions" and the use of a combination of clinical and radiographic measurements for lesion assessment.
Patients enrolled into this study were separated into two cohorts. Cohort A (N=3) was comprised of patients whose disease status was amenable to definitive surgery or radiation following a single cycle of ImmunoPulseâ„¢ IL-12 treatment (i.e., neo-adjuvant). Patients with more advanced disease were enrolled into Cohort B (N=12) and permitted to receive up to four cycles of ImmunoPulseâ„¢ IL-12.
About Merkel Cell Carcinoma (MCC)
MCC is a rare, aggressive cancer with a disease-associated mortality estimated to be three times that of malignant melanoma and affects approximately 1,600 people per year in the US.1-3 The reported incidence has more than tripled over the past 20 years and the health impact of MCC is growing rapidly with a proportional increase in the aging population.2-4 The reported five year relative survival for patients with local, nodal and metastatic disease is 64%, 39% and 18% respectively.1
Treatment options in the metastatic setting are limited for patients. Responses to chemotherapy regimens are usually short-lived and the impact on survival is unclear.5 Also, chemotherapy regimens are associated with toxicity and may not be suitable for MCC patients who tend to be older with multiple co-morbidities.5 Therefore, there is a strong unmet need for biology-driven therapies in MCC.
The recent discovery of the Merkel cell polyomavirus has provided the missing link between MCC and its association with immune suppression.5 MCC tumors are able to evade the immune system by establishing a local immunosuppressive microenvironment. Evidence shows the presence of intratumoral CD8+ T-cells are associated with better prognosis. As such, therapies aimed at promoting intratumoral inflammation may improve MCC patient outcomes.
About OncoSec Medical Incorporated
OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies with an investigational technology, ImmunoPulseâ„¢, for the treatment of cancer. ImmunoPulseâ„¢ is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as IL-12. In Phase I and II clinical trials, ImmunoPulseâ„¢ IL-12 has demonstrated a favorable safety profile and evidence of anti-tumor activity in the treatment of various skin cancers as well as the potential to initiate a systemic immune response. OncoSec's lead program, ImmunoPulseâ„¢ IL-12, is currently in Phase II development for several indications, including metastatic melanoma, squamous cell carcinoma of the head and neck, and triple-negative breast cancer. In addition to ImmunoPulseâ„¢ IL-12, the Company is also identifying and developing new immune-targeting agents for use with the ImmunoPulseâ„¢ platform. For more information, please visit www.oncosec.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "anticipate," "intend," "estimate," "believe," "expect," "future," "may," "should," "will," and similar references to future periods.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they 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. Potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, the following: uncertainties inherent in pre-clinical studies and clinical trials, such as the ability to enroll patients in clinical trials and the risk of adverse events; unexpected new data, safety and technical issues; our ability to raise additional funding necessary to fund continued operations; and the other factors discussed in OncoSec'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 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.
References
Lemos BD, Storer BE, Iyer JG et. al. "Pathologic nodal evaluation improves prognostic accuracy in Merkel cell carcinoma: analysis of 5823 cases as the basis of the first consensus staging system." Journal of the American Academy of Dermatology. 2010 Nov;63(5):751-61.
Lemos B, Nghiem P. "Merkel cell carcinoma: more deaths but still no pathway to blame." Journal of Investigative Dermatology. 2007;127:2100–2103.
Albores-Saavedra J, Batich K, Chable-Montero F, et. al. "Merkel cell carcinoma demographics, morphology, and survival based on 3870 cases: a population based study." Journal of Cutaneous Pathology. 2010 Jan;37(1):20-7.
Hodgson NC. "Merkel cell carcinoma: changing incidence trends." Journal of Surgical Oncology. 2005;89:1–4.
Bhatia S, Afanasiev O, Nghiem P. "Immunobiology of Merkel cell carcinoma: implications for immunotherapy of a polyomavirus-associated cancer." Current Oncology Reports. 2011 Dec; 13(6): 488–497.
Contact
Investor Relations:
Jordyn Kopin
OncoSec Medical Inc.
855-662-6732 FREE
investors@oncosec.com
Media Relations:
Mary Marolla
OncoSec Medical Inc.
855-662-6732 FREE
media@oncosec.com
You must have gotten a personal PR because in the one on the website there is no mention of the word spectacular.
I have missed the word spectacular in the PR
I am pointing to the state of the broader biomarket to give some context
Let me know if you have any bio's in stock that are green today.
I have 1, Anavex
Stop losses with otc stocks is about the dumbest strategy you can have on 'sell-the-news-day' like today.
Prime example today with Oncosec
All it shows is that the market knows shit about science. Roche, AstraZeneca and the DOD know their stuff.
So if it didn't show much how can it be bad ?
My guess would be end of quarter reshuffeling, nothing more or less.
Those periods are defined, believe 60 and 45 days
Google and FDA are your friend
I don't believe we should expect an early termination of a 32-patient p2a study. Maybe in the midst of a 300 patient p3...
No idea but in the call Wilson said she could not attend with him because of a previous DOD meeting
Well we know Perez will not be there (previous DOD engagement)
Wrong crowd.
If the full data confirms the partial, that is huge. Deserves a major science conference for that.
Investors will follow, don't worry
An update on how things are going, probably, but new data? No.
Apparantly $heff got a confirmation from Wilson that fast track and orphan would be filed before end of Q3, so we could have the pr about anyday now.
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$heff, in the TPIV call last week I understood Wilson saying they will file for orphan and fast track before end of the year.
If I understood you correctly Wilson has now confirmed to you that they will file before end of Q3-15 and to obtain it before end of the year?
All great reading but then why did he go in last Monday (running from .50 to .68), only to announce on Tuesay he's out (share price dropping back to .50).
And a week later he goes back in declaring big TPIV love. Where is the logic?
Well we appreciate the value of true tutes support don't we :)
INO is out of love, period
Also, this is not extra money but part of the original 45 mil
"if everything goes well"
that's one giant of a premise!
Just a tiny little correction: Missling has been awarded for 4 million shares for achieving milestones. Only a couple thousand were with his own money.
have you requested that the deletion be reviewed by an admin?
at the moment they have no Investor relations department:
- when you send a mail, there is no answer
- they are not using the email distribution list for PR's, eg the grant
- no automatic notification of new SEC fillings
- too much talk about collaboration but none yet (here I would tell Glynn to stop mentioning it until there is meat to the bone)
I realize that in the bigger picture this is all peanuts, but at some stage they need addressing. The share price is not important due to Dart and if they would really need more then Dart can push it higher so the other warrants above $1 can be exercised.
Were we mentioned?
I agree on the fundamentals but just whished TPIV would step up their game in trying to sell their stuff to the investor community. Then again, Wilson convinced Dart, so interim pps is not that important.
They create expectations (trial initiation, orphan, collaboration...) and then seem to underdeliver. So I would suggest it is better to underpromise and overdeliver.
However I do understand that the grant screwed things up a bit (for the better!). Maybe that should have been stressed some more.
Oh and last of all, he needs to turn of his Outlook and skype when doing a call!
Allow me to play devils advocate:
1) yes they have mentioned collaborations a few times but yet it is only talk so far. You can do that only so many times or the market punished you.
2) the title of the call was "initiation of phase 2". I heard nothing on that in the call. Markets do not like that either.
3) fast track and orphan was promised for q3 but now will be q4. Markets do not like delay.