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Please respond to #132114.
Kevetrin is by no means alone. It is very common that a MTD is not reached. One example is Imbruvica (ibrutinib).
Pharmacyclics was bought by AbbVie for $21bn and Imbruvica (approved for CLL) has projected peak sales of $7bn.
The primary endpoint was to establish MTD. Due to low toxicity they never did so yet the drug is highly efficient.
Please tell me if you also consider the ph1 for Imbruvica a failure?
I agree. And that is why I'm still here.
There really only is one explanation: The market does not trust management at this stage. Lots of institutions and professional seem to trust CTIX and they are willing to invest time and credibility in the compounds. But right now the CEO lacks the credibility it takes to trump those who attack CTIX. Some things he does very well, some things he has not handled very well. Right now, to me, he somehow resembles a used car salesman although I de believe there is more to him than that. But the market doesn't seem the recognize the qualities he also represents. I truly believe that the best thing he could do would be to hire a professional PR person, bring Menon and Jorgensen more to the forefront in the PRs and then stop PRing about President Obama, VP Biden, short attackers and anything else that would make him seem desperate.
@VXL looks more and more like a PD shorther's playground. I'm hoping for slow and steady growth here in CTIX land.
Now, this is potent news. Have a great week all.
I concur. Many more people will hear about CTIX soon. I'd like the CEO to prepare for this by bringing on an experienced PR person to ensure top quality communication on all available platforms. Also so that the CEO can focus on his primary tasks.
Fast Track Designation
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.
Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one. AIDS, Alzheimer’s, heart failure and cancer are obvious examples of serious conditions. However, diseases such as epilepsy, depression and diabetes are also considered to be serious conditions.
Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.
Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, such as:
Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes
Avoiding serious side effects of an available therapy
Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome
Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment
Ability to address emerging or anticipated public health need
A drug that receives Fast Track designation is eligible for some or all of the following:
More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA
Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
Allow me to add to #5:
CTIX is by no means unknown in the scientific community. Several MTAs and great interest at ASCO conferences. Invitation to join the conference in Washington as one of only four presenters (too bad they missed the presentation). Dana Farber et al. ECCMID Copenhagen. The science folks know about CTIX. But these people do not control the pps anymore than the CEO does. Broad recognition by the scientific community does not necessarily result in broad market recognition before we have rock solid late stage results, a partnership and / or eventually revenues.
Please don't get me wrong. I want to uplist. Just a little discouraged here and looking at other companies who uplisted it doesn't seem to be Nirvana. I've come to believe that what will save us is our science.
No. I'm not saying the mc is justified. I'm saying that being on Nasdaq doesn't help. Just look at other companies. Unfortunately, CTIX is currently in a position where there is doubts relating to management and maybe to a certain extend the products. Not amongst well longs who did thorough DD but when it comes to bigger players and the broad market. Add manipulation and short attacks and voila: low market cap. But uplisting won't help. We will be just as vulnerable on Nasdaq. It will take some rock solid validation to bring the mc up to a fair level. Personally, I believe we ought to be 2-4 times today's value.
Wouldn't help a thing. 3rd party validation is all that counts and only that.
Also a very good point.
Rosen: "Your honor, Cellceutix is a scam. Their compounds are no more effective than water"
Judge: "But the FDA seems to like pretty much all of their drugs"
Rosen: "OK. Then let's turn to the office furniture."
A blast from the past - but still a good read.
http://www.stockhouse.com/news/natural-resources/2011/11/04/auspicious-developments-at-pharmaceutical-company
******
I thought it prudent to share with the broader investment community an exciting pharmaceutical stock that I have been following for some time, and that recently has had several noteworthy developments that confirm inter alia its potential to revolutionize the cancer drug industry.
Cellceutix Corp. (OBB: CTIX, Stock Forum) has made what appears to be a breakthrough in oncology with its Kevetrin compound. Kevetrin's in vitro antitumor potency was confirmed in a study that pitted it against pulmonary adenocarcinoma, a recalcitrant cancer of the lungs that begins in the organs epithelial cells. Kevetrin's effects on this particularly drug-resistant malignancy were arresting, literally and figuratively. This novel, tiny antitumor molecule stymied cancer cell progression and induced apoptosis (malignant cell suicide).
The compounds mechanism of action works by exploiting the tumor protein 53. This p53 is a tumor suppressor protein encoded by a gene whose disruption is associated with 55% of all human cancers. For lung carcinomas in particular, the p53 tumor suppressor gene, located on chromosome 17p, is affected in 60-75% of cases. Remarkably, Kevetrin does this all with no genotoxicity. This sets it uniquely apart from all other chemotherapeutic based treatments which inevitably damage the DNA of the patient.
All this scientific argot might not mean much to you, but the eyes and ears of the scientific cognoscenti were acutely attending to Cellceutix' recent presentation at the 102nd Annual Meeting of the American Association for Cancer Research (AARC). By all accounts, it was an unqualified success. Commenting on the interest generated by the Kevetrin presentation, Dr. Sylvia Holden, a scientific consultant for Cellceutix who presented the poster at the AACR gathering, said "I have been participating in the AACR annual meeting for more than twenty years and I can't recall a poster session ever being as active as Cellceutix's was this year.
There were people waiting at our poster before we had arrived and a steady flow of elite scientists at all times up to and through the closing of the session...The manner in which people gravitated to Cellceutix to learn about Kevetrin and its p53 breakthroughs attests to the value of Kevetrin as a novel cancer therapy. We were approached for in-depth conversations by representatives of the world's largest pharmaceutical companies and most prestigious universities in the United States. Moreover, we held a meeting with the National Cancer Institute to discuss the future for Kevetrin development as well. Now that people have gotten a first-hand look at our research explaining the mechanism of action for Kevetrin, the interest that was starting to brew is truly intensifying as organizations of all sizes want to continue discussions back at our offices and lab."
Those in-the-know know the p53 is often referred to as the “Guardian Angel Gene” because of its crucial role in controlling cell mutations. The potential market for Kevetrin is huge. Currently, there are more than 10 million people with tumors that contain inactivated p53, while a similar number have tumors in which the p53 gene is partially inactivated. Kevetrin's activation of p53 functions in tumor cells makes it a promising anticancer drug. Based on the exciting results of the recent studies, Cellceutix plans to commence Phase 1 clinical trials in 2011.
What's more, and strikingly improbable, is that they've already secured a CDA (confidential disclosure agreement) for the compound with a major pharma. On September 26, it was announced that Harvard Medical School's Dana-Farber Cancer Institute, perhaps the most prestigious such center in the world, signed a Laboratory Services Research Support Agreement with Cellceutix. Obviously, the fact that these Harvard white coats have done their own due diligence and have concluded that they want to perform Cellceutix' trials is especially significant. These guys are no dummies; and this ain't their first rodeo. Cellceutix currently trades at $0.35 a share—a 65% reduction from its 52 week high. Considering Kevetrin alone, this is an attractive entry point for a biopharma investor looking for a rare growth opportunity. But Cellceutix has more--much more.
The company has 8 different pharmaceutical compound candidates in the wings. Their proprietary anti-autism compound KM-391 has also received a great deal of press when news of its promising preclinical research was promulgated. Autism is a socially salient disorder, and the parents of sufferers are vocal and keen for a solution. Another, KM-133, also known as Purisol, has been shown to be quite effective against psoriasis in animal studies. In fact, mice treated with Purisol were completely cured of the disease. Check out the astonishing before-and-after photos at the company website. Because the active moiety of the drug is already FDA approved, the company has issued a 505(b)(2) application which will hopefully win it expedited approval.
The company has a seasoned and perspicacious management team at the helm, led by Leo Ehrlich CPA, Chief Executive Officer of the firm. Leo Ehrlich has smartly mitigated risk by growing and diversifying the pipeline of the company, all the while keeping focus on therapeutics with substantial profit potential and broad application (especially in the emerging markets, where a more favorable regulatory market often makes for swifter approval).
The company's president and Chief Scientific Officer, Dr. Krishna Menon, previously developed two drugs for Eli Lilly that have proved massively profitable with present sales in excess of $3 billion. A fortiori, Messrs. Ehrlich and Menon are evidently so convinced of the company's prospects that they are refusing any compensation and are self-funding the entire operation. Not only does this evince complete confidence in the company, it shows a rare and refreshing concern for the dilution of Cellceutix's equity investors. And by all lights the management team has cobbled together a top-shelf scientific research coterie. Emil Frei, a senior member of the company's scientific advisory board, received a lifetime award for his contributions to cancer research at the 2009 AARC convention. And he was again feted at this year’s gathering.
"What Cellceutix is doing with Kevetrin™ can lead to a groundbreaking moment in the world of oncology," commented Cellceutix Scientific Advisor Dr. Emil Frei III, M.D. "In my career, including my tenure as Chief of Medicine at National Cancer Institute, I have seen countless companies throughout the world striving to bridge the gap between damaged or mutated p53 and carcinomas with little to no success. p53 can hold a vital key to the next generation of chemotherapy. Cellceutix's discovery of Kevetrin™, which has been shown to reactivate p53 in a non-genotoxic manner, is a very promising advance in the fight against cancer."
Read more at http://www.stockhouse.com/news/natural-resources/2011/11/04/auspicious-developments-at-pharmaceutical-company#HDIRTlSFtCJ1gg8s.99
Next up (hopefully): Priority review voucher for Kevetrin in ped. Retinoblatoma.
Good find. And thanks for sharing. Great news.
This is another case similar to CTIX where PS allegedly collaborated with Rosen.
http://www.investorvillage.com/smbd.asp?mb=17701&mn=10964&pt=msg&mid=15290196
Fortunately, the Internet never forgets.
https://web.archive.org/web/20151029224404/http://pumpstopper.com/
This might be one of his fellow shorter friends:
http://www.zerohedge.com/news/2015-11-19/devastated-trader-crushed-soaring-biotech-starts-onling-begging-campaign-fund-106000
Wasn't MAKO already exposed ? James DeVries in Ohio as I remember it. Should be fairly easy to find the guy if Sullivan wants to.
AV@L
No lawsuit. But big crash.
Yes. I haven't invested over there either. CTIX is a science monster compared to them.
Of course you're right about that. I just realize, that there are no guarantees what so ever that the pps will go up and stay up just because a company uplists. That other company is crashing bad.
The more I look at the other company's struggle these days the more I think that our CEO is doing the right thing not chasing an uplist to Nasdaq at all costs.
R/S and uplist is definitely a risky thing. Just look at them.
And it proves that shady motives, manipulation and catastrophic price action also is a reality on Nasdaq.
Therefore, I am not so eager to get CTIX uplisted as I have been before. It really doesn't matter. The science matters. A lot. And management.
Uplist will happen when it happens. But it sure isn't a one way ticket to Nirvana.
And to you too !
Yes. Sorry. Couldn't reply. Was in a plane.
Made by Sanofi-Aventis (France), Sun Pharma (India) and Zydus (USA)
Docetaxel is marketed worldwide under the name Taxotere by Sanofi-Aventis [6] as well as Docefrez by Sun Pharma Global and Zytax by Zydus.[7] Annual sales of Taxotere in 2010 were Euro 2.122 billion ($US 3.1 billion). The patent expired in 2010.
Docetaxel
Trade name: Taxotere®
Chemocare.com uses generic drug names in all descriptions of drugs. Taxotere is the trade name for docetaxel. In some cases, health care professionals may use the trade name taxotere when referring to the generic drug name docetaxel.
Drug type: Docetaxel is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. This medication is classified as a "plant alkaloid," a "taxane" and an "antimicrotubule agent." (For more detail, see "How this drug works" section below).
What this drug is used for:
Approved in treatment of breast cancer, non-small cell lung cancer, advanced stomach cancer, head and neck cancer and metastatic prostate cancer.
Also being investigated to treat small cell lung, ovarian, bladder, and pancreatic cancers, soft tissue sarcoma and melanoma.
Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.
How this drug is given:
Docetaxel is given through a vein (intravenously, IV)
There is no pill form of docetaxel
Premedication with a corticosteroid pill starting a day prior to docetaxel infusion for 3 days is given to reduce the severity of fluid retention and allergic reactions. Your doctor will prescribe the exact regimen.
The amount of docetaxel that you will receive depends on many factors, including your height and weight, your general health or other health problems, and the type of cancer or condition being treated. Your doctor will determine your dose and schedule.
Side effects:
Important things to remember about the side effects of docetaxel:
Most people do not experience all of the side effects listed
Side effects are often predictable in terms of their onset and duration
Side effects are almost always reversible and will go away after treatment is complete
There are many options to help minimize or prevent side effects
There is no relationship between the presence or severity of side effects and the effectiveness of the medication.
The side effects of docetaxel and their severity depend on how much of the drug is given. In other words, high doses may produce more severe side effects).
The following side effects are common (occurring in greater than 30%) for patients taking docetaxel:
Low white blood cell count. (This can increase your risk for infection)
Low red blood cell count (anemia)
Nadir: Meaning low point, nadir is the point in time between chemotherapy cycles in which you experience low blood counts.
Onset: 4-7 days
Nadir: 5-9 days
Recovery: 21 days
Fluid retention with weight gain, swelling of the ankles or abdominal area.
Peripheral neuropathy (numbness in your fingers and toes) may occur with repeated doses. This should be reported to your healthcare provider.
Nausea
Diarrhea
Mouth sores
Hair loss
Fatigue and weakness
Infection
Nail changes (Color changes to your fingernails or toenails may occur while taking docetaxel. In extreme, but rare, cases nails may fall off. After you have finished docetaxel treatments, your nails will generally grow back) (see skin problems).
These side effects are less common, meaning they occur in 10-29 percent of patients receiving docetaxel:
Vomiting
Muscle/bone/joint pain (myalgias and arthralgias)
Low platelet count (This can increase your risk of bleeding)
Increases in blood tests measuring liver function. These return to normal once treatment is discontinued. (see liver problems)
Infusion-related side effects (symptoms which may occur during the actual treatment) include:
Allergic reactions (rash, flushing, fever, lowered blood pressure). Happens rarely, usually occurs in the first or second infusion. Frequency is reduced by premedication with corticosteroid starting one day before infusion. You will be monitored closely during the infusion for any signs of allergic reaction.
Infusion site reactions (uncommon and generally mild, consist of darkening of the vein, inflammation, redness or dryness of the skin, or swelling of the vein).
Not all side effects are listed above, some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.
When to contact your doctor or health care provider:
Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:
Fever of 100.4° F (38° C) or higher, chills (possible signs of infection)
The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:
Nausea (interferes with ability to eat and unrelieved with prescribed medication).
Vomiting (vomiting more than 4-5 times in a 24 hour period).
Diarrhea (4-6 episodes in a 24-hour period).
Unusual bleeding or bruising.
Black or tarry stools, or blood in your stools or urine.
Extreme fatigue (unable to carry on self-care activities).
Mouth sores (painful redness, swelling or ulcers).
Yellowing of the skin or eyes.
Swelling of the ankles. Weight gain. Swelling of the stomach.
Shortness of breath.
Always inform your health care provider if you experience any unusual symptoms.
Precautions:
Before starting docetaxel treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Do not take aspirin, products containing aspirin unless your doctor specifically permits this.
Do not receive any kind of immunization or vaccination without your doctor's approval while taking docetaxel.
Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category D (docetaxel may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus).
For both men and women: Do not conceive a child (get pregnant) while taking docetaxel. Barrier methods of contraception, such as condoms, are recommended. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
Do not breast feed while taking this medication.
Self-care tips:
You may be at risk of infection so try to avoid crowds or people with colds or not feeling well, and report fever or any other signs of infection immediately to your health care provider.
Wash your hands often.
To help treat/prevent mouth sores, use a soft toothbrush, and rinse three times a day with 1/2 to 1 teaspoon of baking soda and/or 1/2 to 1 teaspoon of salt mixed with 8 ounces of water.
Use an electric razor and a soft toothbrush to minimize bleeding.
Avoid contact sports or activities that could cause injury.
To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
Avoid sun exposure. Wear SPF 15 (or higher) sunblock and protective clothing. Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
Get plenty of rest.
Maintain good nutrition.
If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.
Monitoring and testing:
You will be checked regularly by your health care professional while you are taking docetaxel, to monitor side effects and check your response to therapy. Periodic blood work to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver) will also be ordered by your doctor.
How this drug works:
Cancerous tumors are characterized by cell division, which is no longer controlled as it is in normal tissue. "Normal" cells stop dividing when they come into contact with like cells, a mechanism known as contact inhibition. Cancerous cells lose this ability. Cancer cells no longer have the normal checks and balances in place that control and limit cell division. The process of cell division, whether normal or cancerous cells, is through the cell cycle. The cell cycle goes from the resting phase, through active growing phases, and then to mitosis (division).
The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis).
Chemotherapy drugs that affect cells only when they are dividing are called cell-cycle specific. Chemotherapy drugs that affect cells when they are at rest are called cell-cycle non-specific. The scheduling of chemotherapy is set based on the type of cells, rate at which they divide, and the time at which a given drug is likely to be effective. This is why chemotherapy is typically given in cycles.
Chemotherapy is most effective at killing cells that are rapidly dividing. Unfortunately, chemotherapy does not know the difference between the cancerous cells and the normal cells. The "normal" cells will grow back and be healthy but in the meantime, side effects occur. The "normal" cells most commonly affected by chemotherapy are the blood cells, the cells in the mouth, stomach and bowel, and the hair follicles; resulting in low blood counts, mouth sores, nausea, diarrhea, and/or hair loss. Different drugs may affect different parts of the body.
Docetaxel belongs to a class of chemotherapy drugs called plant alkaloids. Plant alkaloids are made from plants. The vinca alkaloids are made from the periwinkle plant (catharanthus rosea). The taxanes are made from the bark of the Pacific Yew tree (taxus). The vinca alkaloids and taxanes are also known as antimicrotubule agents. The podophyllotoxins are derived from the May apple plant. Camptothecan analogs are derived from the Asian "Happy Tree" (Camptotheca acuminata). Podophyllotoxins and camptothecan analogs are also known as topoisomerase inhibitors. The plant alkaloids are cell-cycle specific. This means they attack the cells during various phases of division.
Vinca alkaloids: Vincristine, Vinblastine and Vinorelbine
Taxanes: Paclitaxel and Docetaxel
Podophyllotoxins: Etoposide and Tenisopide
Camptothecan analogs: Irinotecan and Topotecan
Antimicrotubule agents (such as docetaxel), inhibit the microtubule structures within the cell. Microtubules are part of the cell's apparatus for dividing and replicating itself. Inhibition of these structures ultimately results in cell death.
Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.
Seems so, yes. I hadn't seen it before.
Interesting Tweet battle between Adam F. and Don Seiffert re CTIX and Sullivan.
Adam F. is totally loosing it.
Michael Sullivan’s law firm works for $CTIX. Why did @BosBizDon omit this important fact from his story today? http://t.co/OBSzBNeA76…
— Adam Feuerstein ✡️ (@adamfeuerstein) October 2, 2015
That post was a lot better read than "going to $0.70 - bank on it." Basically, I agree with much of what you write, but I still don't believe we will ever see $0.70 again and I think the number is randomly picked.
This stock is historically proven to be mostly news driven when it goes up and driven by fear when it tanks. News can alleviate fear.
Maybe some of you who are going to the meeting could ask if he would consider such a move ?
Or just hire a real professional with the know how and experience. That would be a great asset.
It's still on the list. Unfortunately. Hopefully not for long, though.
Sure thing. I also recommend https://groups.google.com/forum/m/?fromgroups#!forum/Clinuvel for DD
Good luck
Another explanation could be that Menon never put together a presentation. Then there would be nothing to make public.
Originally, the CLVLY was 10 shares for one, I believe. I don't hold CLVLF but on ShareScene they discuss the same topic and it appears that CLVLF comes with voting rights.
Lagoda Investment Management now above 7 % ownership in Clinuvel.
http://www.asx.com.au/asxpdf/20151104/pdf/432qp30n7jylg1.pdf