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Why is anyone still interested in this stock? I posted years back they were going to toxic finance the stock down to nothing.
Isn't that apparent yet?
The announcement of the hiring of Ergomed to conduct the 212 patient clinical trial has the important tidbit that the trail is expected to be commenced during the 1st quarter 2025. This stock will be subject to tax loss selling this quarter but should be a good purchase in January 2025. It may break the $1 mark and again be subject to possible delisting.
The FDA is corrupt. Rockefeller took over all medicine and the institutions in the 1920's. He destroyed the natural healing and prevention. The sheep still love chemical pills with side effects and treating instead of natural curing without side effects. There is no $$$ in healthy people. Also TPTB do not want us living long. Kill two birds with one stone (pill).
71 cents lower today than where I sold.
You never know with FDA. They knew for 30 years that a tiny amount of folic acid taken daily by pregnant women would prevent all cleft palettes and split lips in babies, refused to okay it as part of vitamins or supplements until a doctor sued them.
With the latest result indicating an over 80% Survival rate after 5 years as opposed to under 50% without Multikine, it appears that approval is a foregone conclusion after the confirmatory study succeeds. Stock remains a strong buy.
Continued good news - but when will that confirmatory study finally get underway?
CEL-SCI’s Multikine® Increased 5-Year Survival Rate to 82.6% in Locally Advanced Resectable Head & Neck Cancer Patients Who Were Deemed to be in the Treatment Group for Surgery and Radiation
https://www.stocktitan.net/news/CVM/cel-sci-s-multikine-r-increased-5-year-survival-rate-to-82-6-in-9xbf37sch81c.html
CEL-SCI (NYSE American: CVM) reported new data from its Phase 3 study of Multikine® at the ESMO 2024 Congress. The data shows that Multikine increased the 5-year survival rate to 82.6% in locally advanced resectable head and neck cancer patients deemed low risk for recurrence, compared to 47.3% with standard care alone. The treatment also demonstrated a 73% reduction in overall risk of death (hazard ratio of 0.27).
These results are highly relevant to CEL-SCI's upcoming 212-patient confirmatory Registration Study, which has received FDA approval. The study will focus on patients with newly diagnosed locally advanced primary head and neck cancer with no lymph node involvement and low PD-L1 tumor expression. The data suggests that better diagnostic technology, such as PET scans, could further optimize patient selection and improve Multikine's efficacy.
Yes and what the PR says b4 markets open Monday…
Oh ye of little faith. It will be interesting to see what they say at the conference in Barcelona tomorrow.
Highest volume in over 1 month. Hmmm
CVM to present new data for Multikine at the European Society for Medial Oncology 2024 Medical Oncology Congress Saturday 9/13/24 in Barcelona Spain.
From Zack's :
CVM: Start Your Engines – FDA Green Lights Confirmatory Registration Study
08/28/2024
By John Vandermosten, CFA
NYSE:CVM
READ THE FULL CVM RESEARCH REPORT
CEL-SCI Corporation (NYSE:CVM) reported its fiscal third quarter on August 15, 2024 with the submission of its Form 10-Q with the SEC and a press release on the following day. Since our previous update for the fiscal second quarter, CEL-SCI has added several new individuals to its ranks, conducted a population analysis and presented data at IDDST for IT-MATTERS and raised additional capital to support the advance of Multikine towards the confirmatory registrational trial.
Financial Review
CEL-SCI recognized no revenues for its fiscal third quarter ending June 30, 2023 and incurred operating expenses totaling $6.7 million during the three-month period. This resulted in a net loss available to common shareholders of ($7.5) million, or ($0.14) per share.
For the quarter ending June 30, 2023 versus the same prior year period:
- Expenses for research and development fell 18% to $4.7 million from $5.7 million. Lower Phase III study, employee stock compensation and miscellaneous costs contributed to the decrease and were partially offset by increased spending to prepare for the confirmatory registration study;
- General and administrative expenses decreased 20% to $2.0 million from $2.5 million on lower consulting fees and employee stock compensation partially offset by other miscellaneous expenses;
- Other non-operating items were $14,000 compared to ($8,000) in the prior year;
- Net interest expense of ($0.2) million compared with ($0.2) million was related to lease liabilities and was relatively constant;
- Modification of warrants totaled ($659,000) compared to zero as several series of warrants received an extension of expiration dates;
- Net loss totaled ($7.5) million versus ($8.4) million or ($0.14) and ($0.19) per share, respectively.
As of June 30, 2024, cash and equivalents totaled $0.4 million. Cash burn for the three-month period amounted to approximately ($4.6) million, up from 3Q:23’s ($5.9) million. Following the end of the quarter, CEL-SCI closed on a gross $10.8 million common stock offering. CEL-SCI holds no debt on its balance sheet.
CEL-SCI Milestones
- Appointment of Mario Gobbo to Board of Directors – April 2024
- Dr. Giovanni Selvaggi joins CEL-SCI as clinical advisor – June 2024
- Presentation at the International Drug Discovery Science & Technology (IDDST) Congress – June 2024
- Neoadjuvant Immunotherapy for Head and Neck Cancer: Low Tumor PD-L1 Expression - IT-MATTERS – RCT
- Presented by Dr. Eyal Talor
- CEL-SCI appoints Robert Watson as Chairperson of the Board – July 2024
- Feedback from various regulatory agencies - 2024
- Submission of license application to various agencies – 2024+
- Preparation for Multikine confirmatory trial - 2024
Post-Reporting Period Capital Raise
CEL-SCI announced the closing of its $10.8 million offering on July 29th in a press release. The company sold 10,845,000 shares of stock and pre-funded warrants at $1.00 per share. ThinkEquity served as the placement agent for the transaction. A post transaction summary identified 3,715,000 shares of common stock and 7,130,000 pre-funded warrants were issued.
Population Analysis
In further review of the IT-MATTERS data, CEL-SCI has conducted a bias analysis that was detailed in a July 26th press release. The analysis was conducted to ensure data quality, improve study validity, inform the interpretation of the data and to guide the upcoming confirmatory registration study. The data on patients’ age, sex, race, tumor location and staging find that the active arm and control arm are similar. It finds that the results in the study are reliable, generate reasonable conclusions and minimize the risk of bias.
The bias analysis was conducted for the Phase III study population of 923 patients with newly diagnosed resectable, locally advanced primary head and neck cancer, as well as the subgroup of 114 patients who had no lymph node involvement and had low PD-L1 tumor expression (determined via biopsy). This is the same population which will be drawn from for CEL-SCI’s upcoming confirmatory registration study.
Summary
Since our previous update, CEL-SCI has reported its latest quarterly financial and operational results, conducted a population analysis on the IT-MATTERS subjects, presented data at IDDST and added new faces to its ranks. CEL-SCI continues the planning for its anticipated confirmatory registrational study and raised an additional $10.8 million in July to further this effort. We maintain our valuation of $7.00.
It is amazing that investors don't realize that when CVM reveals that they have enrolled the 212 patients to do the confirmatory study, this stock will move higher. If the study shows good preliminary results, they may be fast tracked. Watch for volume surge in the near future. As for the timeline, if they are able to enroll 53 patients a month on average, they would reach the quota on September 8. I'm locked and loaded here.
Obviously the key here will be the success of the upcoming confirmatory trial for those with head and neck cancer that has not spread to the lymph nodes. That group is more likely to survive this pernicious disease that had claimed the lives of loved ones all over the earth. God Bless them and pray that they succeed.
Multikine works. At least we know that now. But this lead-in to getting the confirmatory trial set up is painfully slow.
CVM seems to be “slow tracked”. Been here a really long time. Hoping patience pays off. Good luck to everyone. Maybe we are close. But I have been hoping for years. Let’s go already!! Lol.
And some get fast-tracked:
BioAtlas Ozuriftamab Vedotin Receives FDA Fast-Track Designation; Shares Rise
9:38 AM ET 7/23/24 | MT Newswires
BioAtla's Ozuriftamab Vedotin Receives FDA Fast-Track Designation; Shares Rise
09:38 AM EDT, 07/23/2024 (MT Newswires) -- BioAtla (BCAB) said Tuesday that the US Food and Drug Administration has granted fast-track designation to ozuriftamab vedotin, the company's drug candidate to treat patients with squamous cell carcinoma of the head and neck.
The designation applies to drugs that are intended to treat a serious or life-threatening disease or condition, and have demonstrated the potential to address an unmet medical need.
"The FDA's decision is an important recognition of the potential of our CAB-ROR2-ADC, ozuriftamab vedotin," Chief Executive Jay Short said in a statement. "We look forward to discussing with the FDA plans for a potential registrational trial in the second half of this year."
I wouldn't waste your time with him. A glance through his posting history should tell you all you need to know.
A long time trader with experience.
uhhh ok and what is that from?
18 hours ago
It has been shelved along with UK
Cheers!
what makes you say they're shelved indefinitely
Got out at $1.79 LOL The Canadian and UK deals are shelved indefinitely LOL. I finally did the right thing for once.
OK - so now we're up to a float of ~58 Million shares. Still not bad IF they can get the confirmatory study rolling in the next quarter or two.
PROSPECTUS SUPPLEMENT SUMMARY
This summary highlights selected information contained elsewhere or incorporated by reference in this prospectus supplement and the accompanying prospectus. This summary does not contain all the information that you should consider before investing in our securities. You should read the entire prospectus supplement and the accompanying prospectus carefully, including “Risk Factors” contained in this prospectus supplement and the accompanying prospectus, the financial statements incorporated by reference in this prospectus supplement and the accompanying prospectus, and the other documents identified under the headings “Where You Can Find Additional Information” and “Incorporation of Certain Information by Reference” in this prospectus supplement, before making an investment decision.
THE OFFERING
Common Stock we are offering
3,715,000 shares of common stock
Pre-Funded Warrants
We are also offering 7,130,000 Pre-Funded Warrants to purchase up to 7,130,000 shares of our common stock, exercisable at an exercise price of $0.01 per share, to those purchasers whose purchase of common stock in this offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock immediately following the consummation of this offering. The purchase price of each Pre-Funded Warrant is equal to the price per share of common stock being sold in this offering minus $0.01. The Pre-Funded Warrants will be immediately exercisable and may be exercised at any time until exercised in full. See “Description of Pre-Funded Warrants.” This prospectus supplement also relates to the offering of the shares of common stock issuable upon the exercise of such Pre-Funded Warrants.
Common stock outstanding prior to this offering
54,268,229 shares of common stock.
Common stock to be outstanding after this offering
57,983,229 shares of common stock, assuming no exercise of any Pre-Funded Warrants.
NYSE American Symbol and Listing
Our common stock is listed on the NYSE American under the symbol “CVM.” There is no established public trading market for the Pre-Funded Warrants, and we do not expect a market to develop. We do not intend to list the Pre-Funded Warrants on the NYSE American or any other national securities exchange or nationally recognized trading system. Without an active trading market, the liquidity of the Pre-Funded Warrants will be limited. See “Description of Pre-Funded Warrants.”
Use of Proceeds
We estimate that our net proceeds from this offering will be approximately $9,937,000, after deducting the placement agent fees and estimated offering expenses payable by us, and assuming full exercise of the Pre-Funded Warrants. We intend to use the net proceeds from this offering to fund the continued development of Multikine and for general corporate purposes and working capital. See “Use of Proceeds.”
Risk Factors
Investing in our securities involves significant risks. Please read the information contained in or incorporated by reference under the heading “Risk Factors” beginning on page S-13 of this prospectus supplement, and under similar headings in other documents filed after the date hereof and incorporated by reference into this prospectus supplement and the accompanying prospectus.
The number of shares of common stock shown above to be outstanding after this offering is based on 54,268,229 shares outstanding as of July 26, 2024 and excludes:
16,322,110 shares of our common stock issuable upon the exercise of outstanding stock options at a weighted average exercise price of $6.92 per share; and
1,092,470 shares of our common stock issuable upon the exercise of warrants outstanding at a weighted average exercise price of $3.16 per share.
Except as otherwise indicated, all information in this prospectus supplement assumes (i) no exercise of the outstanding options or warrants described above; and (ii) no exercise of any Pre-Funded Warrants in this offering.
speaking of interesting days, what happened on friday?? lol i was at the fair
58 million shares traded? got up over $2??
Made for an interesting day - that's for certain. Doesn't really change my long-term position here - but I am guessing it aggravated the H_ll out of a lot of folks who got sucked into the buying rush early in the day when it tanked back down to a realistic trading price again.
$1 mid-day offering.
Good luck to anyone still in.
Hopefully this is one they check mark up hard for all.
My WeBull app says halted
Don't see a trade after 10:45am. Halted? It's 11:00am
Yep - Found the trigger - New study out looking to see if there was bias in the old Phase III study - short answer is - they found no bias in either the larger study population, or in the smaller subpopulation that they intend to target in the confirmatory study. Good news, but not the news that we were really waiting for.
https://www.investing.com/news/assorted/celsci-corp-phase-3-population-analysis-for-upcoming-confirmatory-registration-study-in-head--neck-cancer-demonstrates-well-balanced-patient-population-confidence-in-clinical-results-432SI-3539209
CVM....................................https://stockcharts.com/h-sc/ui?s=CVM&p=W&b=5&g=0&id=p86431144783
Yeah, there is news about Phase 3.
Lots of people say an offering is near.
It's Bio, so it's dangerous to hold, given the recent trend of mid-day offerings, it's becoming more risky to even trade them during the day.
About 6.5 million shares traded in the first 15 minutes? Share price currently a shade over $2? Somebody thinks that something is up this morning. No news posted on the Cel-Sci website though.
Very good news, let’s go higher!!
Thank you for this.
A long time in the making.
At least it explains why every pop in trading is being sold off again now.
A real nice move to $1.75
Over 3.5M shares traded before 9am.
CEL-SCI’s Phase 3 Population Analysis for Upcoming Confirmatory Registration Study in Head & Neck Cancer Demonstrates Well Balanced Patient Population, Confidence in Clinical Results
Multikine, a true first-line cancer immunotherapy, cut the 5-year risk of death by half compared to control in its target population
Bias analysis conducted in preparation for submission of data to regulatory agencies including the FDA for confirmatory registration study
Detailed data on parameters including patient age, sex, race, tumor locations, and staging demonstrate balance between the treatment and control arms, no bias found, supporting confidence in Multikine’s efficacy results
CEL-SCI Corporation (NYSE American: CVM) today reported positive results from a bias analysis conducted for its concluded Phase 3 study of Multikine (Leukocyte Interleukin, Injection)* in the treatment of head and neck cancer. Conducting a bias analysis is a standard process used to identify, assess, and address potential sources of bias that could influence the outcomes and interpretations of study results. The goal of a bias analysis is to ensure that the trial's findings are reliable, the conclusions are valid, and to minimize the risk that bias has distorted the results.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240726306579/en/
The above table includes detailed results from the bias analysis involving the 2 groups, treated vs. control (Graphic: Business Wire)
The above table includes detailed results from the bias analysis involving the 2 groups, treated vs. control (Graphic: Business Wire)
CEL-SCI’s bias analysis concluded that the treatment group demographics and baseline characteristics were comparable for the Multikine treated and control arms of the Phase 3 study. There were no confounding baseline parameters in the Multikine-treated versus control population. No bias was present in the study and none was detected in favor of the investigational product, Multikine. As such, the study data are reliably interpretable, statistically significant and have been shown to support the clinical effect of neoadjuvant (pre-surgery) Multikine immunotherapy in extending the life of these patients in the Phase 3 study.
This is critically important information because CEL-SCI, with the FDA’s agreement, will be conducting a 212-patient confirmatory registration study for Multikine. The target population for the confirmatory study shows a 5-year survival in advanced primary head and neck cancer of 73% in Multikine treated patients vs. 45% survival in the control.
“Multikine’s efficacy results in the target population are truly impressive and the bias analysis is critical to demonstrate a high degree of confidence in the data. A hazard ratio of 0.35 with an upper limit of 0.66 is excellent and suggests a very high chance to repeat the great survival benefit from Multikine. The bias analysis showed that the survival benefit is truly from Multikine as opposed to an imbalance in the patient population,” stated CEL-SCI CEO Geert Kersten. “We are pleased to share the baseline results as we prepare to submit the data to regulators ahead of our upcoming confirmatory registration study.”
The bias analysis was conducted for the entire Phase 3 study population of 923 patients with newly diagnosed resectable, locally advanced primary head and neck cancer, as well as the subgroup of 114 patients who had no lymph node involvement and had low PD-L1 tumor expression (determined via biopsy), the target population for CEL-SCI’s upcoming confirmatory registration study.
About CEL-SCI Corporation
CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor.
Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, has been dosed in over 750 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Multikine significantly extended life in its target patient population demonstrating a 73% survival rate with Multikine vs. only 45% without at 5 years after treatment. Based on this very strong data, the FDA agreed to CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a small, focused, confirmatory Registration Study which will enroll 212 patients. CEL-SCI will enroll newly diagnosed locally advanced primary head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing over 100,000 patients annually.
The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.
Thursday's daily short sale volume was 31.36% (as reported by FINRA) and the shorts managed to get the PPS down with their heavy manipulations. However, the short borrow fee is up to 103.91% and the short shares availability came down from more than a million shares to 400 shares that are currently available! With all the expected news coming in from EMA, MHRA, Health Canada and FDA, it should just be a matter of time until Multikine will be approved and the heavy manipulation by the shorts will come to an end. To keep the PPS low, the shorts have increased their position by another 230'000 to currently 8.46 million shorted shares (short float of 16.13%). I am so happy for all the cancer patients who will hopefully soon be able to profit from Multikine! GLTAL!! Tick tock, tick tock...
Interesting move up this morning - volume is kind of light though for it to seem like anything 'real' is up.
Yesterday's daily short sale volume was 22.30% (as reported by FINRA) but despite all the heavy manipulations by the shorts, the PPS went up 14.5%. The short borrow fee is up to 81.71% and the short shares availability came down from more than a million shares to 40'000 shares that are currently available! With all the expected news coming in from EMA, MHRA, Health Canada and FDA, it should just be a matter of time until Multikine will be approved and the heavy manipulation by the shorts will come to an end. To keep the PPS low, the shorts have increased their position by another 200'000 to currently 8.21 million shorted shares (short float of 15.66%) - up almost 1 million shares since last month. I am so happy for all the cancer patients who will hopefully soon be able to profit from Multikine! GLTAL!! Tick tock, tick tock...
Change in management - New Chairman - Guy with experience in raising money.
https://feeds.issuerdirect.com/news-release.html?newsid=5946140769547282
July 8, 2024 9:15 AM
CEL-SCI Appoints Robert Watson as Chairperson of the Board
CEL-SCI Corporation (NYSE American: CVM) today announced that Robert (“Bob”) Watson, who has served as a Director of the Company since 2017, has been appointed Chairperson of the Board.
Bob is an accomplished business leader who began his career as an investment banker. With over four decades of experience across various healthcare markets, Bob brings extensive expertise in capital formation strategies and partnerships to drive an efficient capital structure. During his career as CEO or President of private and publicly traded companies in the healthcare sector, Bob negotiated over a half dozen exits and more than $750 million in capital transactions including IPOs, secondary offerings, and debt instruments.
“I have greatly appreciated Bob’s guidance as a Director of CEL-SCI. His recent retirement from an active CEO role created the bandwidth for him to assume additional responsibilities as our Chairperson. The team and I are excited to have Bob involved at this level where his capital markets expertise will be highly valuable,” stated CEL-SCI CEO Geert Kersten.
Based on robust efficacy and safety data in over 750 patients for its immunotherapy drug, Multikine, CEL-SCI received the U.S. Food and Drug Administration’s go-ahead to conduct a confirmatory Registration Study for the treatment of newly diagnosed advanced primary head and neck cancer. Multikine, a true first-line cancer therapy, significantly extended life in its target patient population demonstrating a 73% survival rate with Multikine vs. only 45% without at 5 years after treatment. The small, focused, confirmatory Registration Study will enroll only 212 patients with a high unmet need for an estimated 100,000 patients annually.
Bob Watson commented, “Having been on the path with CEL-SCI toward FDA approval of Multikine, it is my honor to be able to stand side by side with the management team as we complete the final leg of this amazing journey to bring a pre-surgical immunotherapy to patients with head and neck cancer. As stated previously, we are very confident that the Registration Study will confirm the excellent safety and efficacy results demonstrated in prior studies.”
About CEL-SCI Corporation
CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor.
Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, has been dosed in over 750 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Multikine significantly extended life in its target patient population demonstrating a 73% survival rate with Multikine vs. only 45% without at 5 years after treatment. Based on this very strong data, the FDA agreed to CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a small, focused, confirmatory Registration Study which will enroll 212 patients. CEL-SCI will enroll newly diagnosed advanced primary head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing over 100,000 patients annually.
The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2023. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240708501317/en/
Gavin de Windt
CEL-SCI Corporation
(703) 506-9460
Friday's daily short sale volume was 55.72% (as reported by FINRA) but despite all the heavy manipulations by the shorts, the PPS went up 10.00%. The short borrow fee went up to 85.44% and the short shares availability came down from more than a million shares to only 2000 shares that are currently available! With all the expected news coming in from EMA, MHRA, Health Canada and FDA, it should just be a matter of time until Multikine will be approved and the heavy manipulation by the shorts will come to an end. To keep the PPS low, the shorts have increased their position to currently 8.04 million shorted shares (short float of 15.33%) - up almost 1 million shares since last month. I am so happy for all the cancer patients who will hopefully soon be able to profit from Multikine! GLTAL!! Tick tock, tick tock...
Cel-Sci Corporation (CVM)
https://www.youtube.com/watch?v=auAihG3rtC4
Multikine® (Leukocyte Interleukin, Injection) is the full name of this investigational therapy, which, for simplicity, is referred to in the remainder of this page as Multikine*.
Multikine, CEL-SCI's lead investigational immunotherapy, is an immunotherapeutic agent that is being developed as a potential first-line treatment for advanced primary head and neck cancer. If it were to be approved for use following completion of CEL-SCI's clinical development program, Multikine would be a different kind of therapy in the fight against cancer; one that appears to have the potential to work with the body's natural immune system in the fight against tumors.CANCER - MULTIKINE
Multikine may also have the potential to be a first in a new class of cancer immunotherapy drugs. It is the first investigational combination immunotherapy thought to have both passive and active immune properties. More...INFECTIOUS DISEASES - L.E.A.P.S.(TM)**
L.E.A.P.S is a patented, T-cell modulation, peptide epitope delivery technology that enables CEL-SCI to design and synthesize proprietary peptide immunogens. L.E.A.P.S. compounds consist of a small T-cell binding peptide ligand linked with a disease-associated peptide antigen.
This new technology has been shown the potential in several animal models to preferentially direct immune response to a cellular (e.g., T-cell), humoral (antibody) or mixed pathway. Diseases for which antigenic epitope sequences have been identified, such as some infectious diseases, cancer, autoimmune diseases, allergic asthma and allergy, and select CNS diseases (e.g., Alzheimer's) may be potential candidates for development using this technology platform. More...* Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with our future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or by any other regulatory agency. Similarly, its safety of efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data summarized on this page or elsewhere on this website involving the investigational therapy Multikine (Leukocyte Interleukin, Injection). Further research is required, and early-phase clinical trial results must be confirmed in the well-controlled, Phase III clinical trial of this investigational therapy that is currently in progress.
** L.E.A.P.S. is the trademark of CEL-SCI for this investigational platform technology, and this proprietary name is subject to FDA review. No L.E.A.P.S. product has been approved for sale, barter or exchange by the FDA or any other regulatory agency for any use to treat disease in animals or humans. The safety or efficacy of these products has not been established for any use. Lastly, no definitive conclusions can be drawn from these early-phase, preclinical-trials data involving these investigational products
Partnering Philosophy & Corporate Partners
CEL-SCI's partnering philosophy is guided by the belief that any partnership entered into should serve the best interests of:
CEL-SCI is open to any reasonable partnership proposals that will accelerate its being able to bring its medicines to market.
Multikine (Leukocyte Interleukin, Injection) is the full name of this investigational therapy, which, for simplicity, is referred to in the remainder of this page as Multikine*.
CEL-SCI has a unique expertise in the development and manufacture of complex biologics. CEL-SCI is not a company that markets and sells drug products at the current time. Regardless, CEL-SCI believes it will be capable of marketing and selling Multikine on its own for head and neck cancer in both the United States and Europe if and once it is approved by the FDA (or EU regulators). Since its primary target is head & neck cancer surgeons, a rather small audience, CEL-SCI does not believe that a large sales force will be needed to commercialize Multikine, if and once it is approved by the FDA (or EU regulators) following the review of the total Multikine Biologics License Application.
Current Corporate Partners:
a. | Agreement Signed August 2008 | ||
b. | Territory - Israel, Turkey, expanded to also cover Serbia and Croatia in August 2011. | ||
c. | Revenue Share | ||
d. | Website - http://www.tevapharm.com/ |
a. | Agreement Signed November 2000 | ||
b. | Territory - Taiwan, Singapore, Hong Kong, Malaysia, expanded to also cover South Korea, the Philippines, Australia and New Zealand in the Fall of 2008. | ||
c. | Revenue Share | ||
d. | Website - http://www.oep.com.tw/ |
a. | Agreement signed August 2011 | ||
b. | Territory - Argentina and Venezuela | ||
c. | Revenue Share | ||
d. | Website - http://www.gp-pharm.com/ |
Based on the Company's L.E.A.P.S.TM** technology, as long as a disease epitope is available, CEL-SCI may be able to develop an effective treatment/vaccine using the L.E.A.P.S. technology. The two leading candidates derived from this technology are the H1N1 treatment being developed as a possible treatment option for hospitalized patients and the Rheumatoid Arthritis treatment vaccine currently being tested in animal models of the disease.
* Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with our future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data summarized on this page or elsewhere on this website involving the investigational therapy Multikine (Leukocyte Interleukin, Injection). Further research is required, and early-phase clinical trial results must be confirmed in the well-controlled, Phase III clinical trial of this investigational therapy that is currently in progress.
** L.E.A.P.S. is the trademark of CEL-SCI for this investigational platform technology, and this proprietary name is subject to FDA review. No L.E.A.P.S. product has been approved for sale, barter or exchange by the FDA or any other regulatory agency for any use to treat disease in animals or humans. The safety or efficacy of these products has not been established for any use. Lastly, no definitive conclusions can be drawn from these early-phase, preclinical-trials data involving these investigational products.
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https://frugalnorwegian.com/cvm Insight into CVM P3 Trial Results
https://www.cvmresearch.com Insight into CVM P3 Trial Results & FDA Chances of Approval
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