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Post by selluwud on Oct 15, 2014 13:07:45 GMT
Looks like my buy in yesterday was good, at least for now. Advaxis Provides Clinical Update for Phase 1/2 Trial of ADXS-HPV Immunotherapy Product Candidate in Anal Cancer Open-Label Study Conducted by Brown University Oncology Group Shows Promising Preliminary Data, Triggering Study Expansion to Two Additional Sites finance.yahoo.com/news/advaxis-provides-clinical-phase-1-113000929.html |
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Post by Jimmywho on Dec 8, 2014 15:01:34 GMT
Advaxis Announces FDA Acceptance of Its Investigational New Drug Application to Commence Clinical Trials of ADXS-PSA in Combination With Merck's KEYTRUDA(R) (pembrolizumab) for Prostate Cancer 12/08/2014 | 07:30 AM ET | GlobeNewswire PRINCETON, N.J., Dec. 8, 2014 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to conduct a Phase 1/2 clinical study to evaluate the combination of ADXS-PSA (ADXS31-142) with KEYTRUDA® (pembrolizumab), marketed by Merck & Co., Inc., in patients with previously treated, metastatic castration-resistant prostate cancer (mCRPC). The clinical trial, which will be the first-in-human study of Advaxis's lead Lm-LLO immunotherapy product candidate in prostate cancer, is expected to begin patient enrollment in the first quarter of 2015. The open-label Phase 1/2 clinical trial is designed to evaluate the safety and efficacy of ADXS-PSA as a monotherapy and in combination with KEYTRUDA, the first anti-PD-1 (programmed death receptor-1) therapy approved in the United States. KEYTRUDA is developed and marketed by Merck. The Phase 1 part of the study will be a dose-escalating study designed to establish the maximum tolerated dose of ADXS-PSA when used alone and in combination with KEYTRUDA. The Phase 2 portion will assess the safety and efficacy of the combination immunotherapy regimen. Advaxis and Merck will collaboratively oversee the conduct of the study and will use the results from the trial to determine the future clinical development program for the combination. "Combinations of immunotherapies are the future of cancer research," stated Daniel J. O'Connor, President and Chief Executive Officer of Advaxis. "We are extremely pleased with FDA's acceptance of this IND because it gives us the opportunity to conduct clinical trials of ADXS-PSA in combination with an important, FDA approved PD-1 inhibitor, KEYTRUDA." O'Connor continued, "This open-label study will provide Advaxis clinical data by which we can evaluate the potential of our proprietary Lm-LLO immunotherapy technology to enhance the activity of an anti-PD-1 antibody. During preclinical studies, our immunotherapies demonstrated a synergistic anti-tumor immune response when combined with a PD-1 inhibitor. We look forward to the possibility of seeing these encouraging results again, this time in a clinical setting, with the hopes of offering a promising alternative treatment option for patients diagnosed with an aggressive and difficult to treat form of prostate cancer." ADXS-PSA and KEYTRUDA are members of a new class of cancer treatments known as immunotherapies, which are designed to enhance the body's own defenses in fighting cancer. Data from preclinical studies suggest that AdvaxisLm-LLO immunotherapies in combination with a PD-1 inhibitor may lead to an enhanced anti-tumor immune response. About Prostate Cancer Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in six will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that approximately 233,000 new cases of prostate cancer will be diagnosed and about 30,000 men are expected to die of the disease this year. For more information please visit www.advaxis.com. KEYTRUDA is a registered trademark of Merck & Co., Inc. CONTACT: Company: Advaxis, Inc.Greg Mayes, Executive Vice President and COO mayes@advaxis.com 609.452.9813 ext. 102 Media Contact: Tiberend Strategic Advisors, Inc.Amy S. Wheelerawheeler@tiberend.com 646.362.5750 Source: Advaxis |
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Post by jckrdu on Dec 11, 2014 12:02:29 GMT
ADXS is still guiding the submission of 2 more INDs in 2014. See slide 21 in their latest deck below which was updated last week. Question is, will they submit these INDs with a partner, or go it alone? If they don't announce a partner to offset the costs associated with these trials, pps is more likely to take a hit as the market will continue to question where the cash is going to come from to pay for all these trials. ADXS could surprise to the upside with the announcement of a partnership with some upfront cash for their her-2 (breast cancer, pediatric osteosarcoma) program. content.stockpr.com/advaxis/media/0ab31113e906ebf056c14ef596995d94.pdf |
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Post by Jimmywho on Dec 11, 2014 13:35:50 GMT
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Post by Jimmywho on Dec 12, 2014 18:06:47 GMT
Also today, Advaxis's Cancer Immunotherapies Featured on FOX News PRINCETON, N.J., Dec. 12, 2014 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq:ADXS), a biotechnology company developing cancer immunotherapies, announced that its Lm-LLO immunotherapy technology is featured on FOX News Channel in a broadcast segment and article, entitled, "Teaching the immune system to fight back against cancer." The segment and accompanying article can be accessed via the following URL: www.foxnews.com/health/2014/12/10/teaching-immune-system-to-fight-back-against-cancer/ |
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Post by Jimmywho on Dec 15, 2014 15:01:22 GMT
More news today Advaxis Announces FDA Acceptance of Its Investigational New Drug Application to Commence Clinical Trials of ADXS-HPV in Combination With MedImmune's MEDI4736 for the Treatment of HPV-Associated Cancers COMPANIES PLAN TO IMMEDIATELY INITIATE PHASE 1/2 CLINICAL TRIAL IN CERVICAL AND HEAD & NECK CANCER PRINCETON, N.J., Dec. 15, 2014 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to conduct a Phase 1/2 clinical study of ADXS-HPV (ADXS11-001) alone or in combination with MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, for the treatment of advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer. The trial is expected to begin patient enrollment in early 2015. This follows the press release issued in July 2014 announcing the clinical trial collaboration between Advaxis and MedImmune, the global biologics research and development arm of AstraZeneca. ir.advaxis.com/press-releases/detail/924/advaxis-announces-fda-acceptance-of-its-investigational-new-drug-application-to-commence-clinical-trials-of-adxs-hpv-in-combination-with-medimmunes-medi4736-for-the-treatment-of-hpv-associated-cancers |
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Post by Jimmywho on Dec 17, 2014 18:22:23 GMT
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Post by jckrdu on Dec 18, 2014 3:30:21 GMT
ADXS on a nice run the last few weeks. Congrats to all holding!
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Post by Jimmywho on Jan 5, 2015 14:42:25 GMT
FOLLOWING FDA REVIEW COMPANY TO INITIATE CLINICAL TRIAL FOR THE TREATMENT OF HER2 EXPRESSING SOLID-TUMORS PRINCETON, N.J., Jan. 5, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc.(Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that it submitted an Investigational New Drug (IND) application to the United States Food and Drug Administration (FDA) to conduct the first-in-human study of ADXS-HER2 (ADXS31-164) for the treatment of HER2 expressing solid tumors. The trial will be initiated in the first quarter of 2015. In May 2014, Advaxis was granted orphan drug designation for ADXS-HER2 in osteosarcoma. www.advaxis.com/news/detail/954/advaxis-submits-investigational-new-drug-application-to-fda-for-adxs-her2 |
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Post by Jimmywho on Jan 6, 2015 13:26:46 GMT
Form 10-K for ADVAXIS, INC. 6-Jan-2015 Annual Report ITEM 7. Management's Discussion and Analysis of Financial Condition and Results of Operations. This Management's Discussion and Analysis of Financial Conditions and Results of Operations and other portions of this report contain forward-looking information that involves risks and uncertainties. Our actual results could differ materially from those anticipated by the forward-looking information. Factors that may cause such differences include, but are not limited to, availability and cost of financial resources, product demand, market acceptance and other factors discussed in this report under the heading "Risk Factors". This Management's Discussion and Analysis of Financial Conditions and Results of Operations should be read in conjunction with our financial statements and the related notes included elsewhere in this report. biz.yahoo.com/e/150106/adxs10-k.html |
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Post by Jimmywho on Jan 7, 2015 13:14:17 GMT
Advaxis and the GOG Foundation, Inc. to Collaborate on Global Phase 3 Clinical Trial of ADXS-HPV in Cervical Cancer Download PDF STUDY TO EVALUATE ADVAXIS'S LEAD CANCER IMMUNOTHERAPY IN HIGH-RISK, LOCALLY ADVANCED CERVICAL CANCER PRINCETON, N.J., Jan. 7, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced today that it is entering into a clinical trial collaboration agreement with the GOG Foundation, Inc., (GOG Foundation), to evaluate the safety and efficacy of Advaxis's lead cancer immunotherapy, ADXS-HPV, in a global Phase 3 cervical cancer trial. ADXS-HPV is an investigational Lm-LLO immunotherapy bioengineered to generate an immune response to the HPV-associated tumor specific oncogene. www.advaxis.com/news/detail/964/advaxis-and-the-gog-foundation-inc-to-collaborate-on-global-phase-3-clinical-trial-of-adxs-hpv-in-cervical-cancer |
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Post by iamaverb on Jan 8, 2015 16:00:49 GMT
I have stuck with ADXS for years now, since early news of their India clinical trials. It never really dropped much below where my cost average was so I held on and am up well over 200% as of today. I wish I had more than my 10K shares. Now, with the number of shares I have with OCAT if the same thing will play out for OCAT I will be one happy person.
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Post by selluwud on Jan 8, 2015 16:01:56 GMT
Great play Verb
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Post by JHam on Jan 8, 2015 21:14:38 GMT
I have stuck with ADXS for years now, since early news of their India clinical trials. It never really dropped much below where my cost average was so I held on and am up well over 200% as of today. I wish I had more than my 10K shares. Now, with the number of shares I have with OCAT if the same thing will play out for OCAT I will be one happy person. That's awesome! ADXS has officially left the station. Secured financing and moving full steam ahead with their combination trial. The market definitely likes it. Hoping this is what we see from ONCS in the future (for my sake). Good luck! |
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Post by Yelk on Jan 9, 2015 3:44:32 GMT
I have stuck with ADXS for years now, since early news of their India clinical trials. It never really dropped much below where my cost average was so I held on and am up well over 200% as of today. I wish I had more than my 10K shares. Now, with the number of shares I have with OCAT if the same thing will play out for OCAT I will be one happy person. That's awesome! ADXS has officially left the station. Secured financing and moving full steam ahead with their combination trial. The market definitely likes it. Hoping this is what we see from ONCS in the future (for my sake). Good luck! I missed the train for this one, probably too late to buy a ticket. Grats on holders! |
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Post by natureeguy on Jan 15, 2015 14:20:41 GMT
Hi Folks, Haven't posted in a long time. Just want to say thanks again to JCKRDU. His writings really led me to purchase a ton of this when it was 3 and under. I owe you a beer or thousands.  Just wondering why more folks don't post about this stock...It's increased so much the last month or so, and looks more and more promising as time goes on. I know ocat is a cult stock,,and I even owned a ton for 7 years until I sold it all to buy adxs, but this is so much more lucrative then perhaps ocat will ever be... Does anybody believe in this stock? It's really changing my financial life tremendously. I also own oncs...thanks to Jham.... Hoping that will one day take off like adxs. Best wishes everyone |
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Post by selluwud on Jan 15, 2015 16:22:08 GMT
Hi Folks, Haven't posted in a long time. Just want to say thanks again to JCKRDU. His writings really led me to purchase a ton of this when it was 3 and under. I owe you a beer or thousands. Just wondering why more folks don't post about this stock...It's increased so much the last month or so, and looks more and more promising as time goes on. I know ocat is a cult stock,,and I even owned a ton for 7 years until I sold it all to buy adxs, but this is so much more lucrative then perhaps ocat will ever be... Does anybody believe in this stock? It's really changing my financial life tremendously. I also own oncs...thanks to Jham.... Hoping that will one day take off like adxs. Best wishes everyone Great investment move. I used to own ADXS, but flipped from 2.80 to 3.80 and was happy to do it. Coulda, shoulda, woulda!! |
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Post by RLC on Jan 15, 2015 16:34:14 GMT
Hi Folks, Haven't posted in a long time. Just want to say thanks again to JCKRDU. His writings really led me to purchase a ton of this when it was 3 and under. I owe you a beer or thousands. Just wondering why more folks don't post about this stock...It's increased so much the last month or so, and looks more and more promising as time goes on. I know ocat is a cult stock,,and I even owned a ton for 7 years until I sold it all to buy adxs, but this is so much more lucrative then perhaps ocat will ever be... Does anybody believe in this stock? It's really changing my financial life tremendously. I also own oncs...thanks to Jham.... Hoping that will one day take off like adxs. Best wishes everyone Congrats natureeguy! I owned a good position of ADXS as well with a cost basis under $3 thanks to Jckrdu. He had done some stellar DD on this company. Unfortunately, some other company was supposed to be releasing interim data that I thought would create an easy double or more and I decided to sell out of ADXS to put my money there. It ended up being a horrible decision (in hindsight). I bet no one can guess the company. |
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Post by Jimmywho on Jan 28, 2015 13:34:11 GMT
Gynecologic Oncology Group (GOG) Phase 2 Study of Advaxis's Lm-LLO Immunotherapy, ADXS-HPV, for the Treatment of Persistent or Recurrent Cervical Cancer Achieves Safety and Efficacy Criteria GOG 0265, AN NRG ONCOLOGY/GOG STUDY, WILL NOW PROCEED TO ENROLL ADDITIONAL PATIENTS INTO STAGE 2 OF THE STUDY PRINCETON, N.J., Jan. 28, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced an update related to the Phase 2 open-label clinical study of ADXS-HPV (ADXS11-001) in patients with persistent or recurrent cervical cancer with documented disease progression being conducted by the Gynecologic Oncology Group (GOG), now part of NRG Oncology. The study, known as GOG 0265, has completed its first stage and has met the predetermined safety and efficacy criteria required to proceed into the second stage of patient enrollment. This trial is being conducted in the U.S. by the GOG, under the sponsorship of the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI). www.advaxis.com/news/detail/1014/gynecologic-oncology-group-gog-phase-2-study-of-advaxiss-lm-llo-immunotherapy-adxs-hpv-for-the-treatment-of-persistent-or-recurrent-cervical-cancer-achieves-safety-and-efficacy-criteria |
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Post by jckrdu on Jan 31, 2015 0:54:10 GMT
Hi Folks, Haven't posted in a long time. Just want to say thanks again to JCKRDU. His writings really led me to purchase a ton of this when it was 3 and under. I owe you a beer or thousands. Just wondering why more folks don't post about this stock...It's increased so much the last month or so, and looks more and more promising as time goes on. I know ocat is a cult stock,,and I even owned a ton for 7 years until I sold it all to buy adxs, but this is so much more lucrative then perhaps ocat will ever be... Does anybody believe in this stock? It's really changing my financial life tremendously. I also own oncs...thanks to Jham.... Hoping that will one day take off like adxs. Best wishes everyone Natureeguy,
Thanks for the message, and congratulations to you and everyone else that made some good money on ADXS.
You guys persevered and held a long time.... I can't tell you how happy I am to read that its made a difference in your financial life.
I still follow ADXS, but not as closely as I moved out awhile ago into some other stocks that have served me well... although not a triple from $3 like ADXS has moved.
I still do think that ADXS is a good long-term investment, but I'm not sure how much more its going to move from the current $10ish pps and $240 million market cap until the Phase 2 combination trial results with Merck and Astra are out. I was more interested in ADXS when it was a $50MM market cap company with very promising technology. I do think the move up to the billion dollar market cap level will come, but it may take a little while longer.
Anyway, just wanted to congratulate all of you.
Best,
jck
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