is...wondering why God loves us so much?
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i really couldn't agree more with you - i think with FDA/IND news being imminent it would make great for a nice momentum play as well as long term gains. I like this product a lot on the point of Stem cell/embryonic/and being completely ethical.
Asuoto,
I'm using TD Ameritrade i'm surprised people are having problems buying? or maybe i misunderstood..
Ernie.
Sweet! I think i used the wrong terminology - i meant it to mean "not to jinx your position; i don't believe it will ever hit 2 cents again lol" More power to you!!! - yes, i 100% agree with you - i like $ACTC a lot!!! :) undervalued & promising pipeline. Great technology as well as legitimacy.
No problem brother - :)
I ended up posting the whole thing figuring it shouldn't be violating any IHUB rules :) glad it worked out - Good luck to all of us on here :)
Ernie :)
I love how we're on the same page on this - a big part of the medical arena is ethics. Now with Stem Cells/embryonic vs epethelial vs god knows what else it makes R&D at a stand still rather than work to better the lives of many people. I believe ACTC definately has the right approach - both through science and an ethical point of view. I don't see this as a penny stock for long & aka it is a growth stock - not to reign on your parade you've already quintupled your investment in 1 yr. i highly doubt it will see 2 cents ever again - Good Luck to you!! :)
Awe Louisa - thank you so much - hope it pays off for all of us...more credit goes to the source -
I love the art piece you posted - what biblical scene is it of?
Part 6
News Affecting ACTC
Judge Throws Out Stem Cell Lawsuit
by Jocelyn Kaiser
A federal judge has rejected a lawsuit challenging the Obama Administration's policy lifting restrictions on using federal funds to study human embryonic stem cells. Christian groups had sued the National Institutes of Health in August, arguing on behalf of themselves and embryos that NIH's stem cell guidelines violate a ban on using federal funds to create or destroy human embryos. According to Bloomberg, U.S. District Court Judge Royce Lamberth ruled yesterday in Washington, D.C., that the groups had no standing because the U.S. Supreme Court has found that embryos are not persons under the law, and the unborn have no constitutional right to life. The AP's story says the judge also rejected the argument that the guidelines would reduce the number of embryos available for adoption. http://blogs.sciencemag.org/scienceinsider/2009/10/judge-throws-ou.html
Recent Company News
Advanced Cell Technology, Inc.'s Shares To Trade On Over-the-Counter Bulletin Board
Tuesday, 6 Oct 2009 07:40am EDT
Advanced Cell Technology, Inc. announced that effective immediately the Company's shares will be traded on the Over-the-Counter Bulletin Board under its previous ticker symbol ACTC. The Company is now fully reporting and up-to-date with all of its filing requirements. The Company`s stock had previously traded on the Pink Sheets.
Advanced Cell Technology, Inc. Completing Pre-Clinical Activities In Preparation For IND Filing
Tuesday, 22 Sep 2009 11:28am EDT
Advanced Cell Technology, Inc. announced an update on pre-clinical activities in preparation of its first IND filing with the Food and Drug Administration for its retinal pigment epithelium (RPE) cell program for the treatment of various eye diseases. In the next few weeks, the Company will be completing the preclinical work necessary for filing the IND. To date, no adverse events have occurred in testing. The results will be part of the submission which Advanced Cell expects to submit to the FDA prior to the end of the year.
Advanced Cell Technology, Inc. and Collaborators At The Casey Eye Institute Present Promising Data Supporting Safety and Efficacy of Stem Cell Therapy to Combat Retinal Disease
Friday, 12 Jun 2009 09:39am EDT
Advanced Cell Technology, Inc. and its collaborators at OHSU reported the long-term safety and efficacy of human embryonic stem cell (hESC)-derived retinal pigment epithelium (RPE) produced under manufacturing conditions suitable for human clinical trials. Two important early potential hESC applications are the use of RPE for the treatment of age-related macular degeneration and Stargardt disease, an untreatable form of eye disease that leads to early-onset blindness. The research, which appears online ahead of print in the journal Stem Cells, shows long-term functional rescue using hESC-derived cells in both the RCS rat and Elov14 mouse, animal models of retinal degeneration and Stargardt, respectively. The cells survived transplantation for prolonged periods (>220 days) and sustained visual function without tumor formation or untoward pathological reactions. Near-normal functional rescue was also achieved in the `Stargardt` mouse. To further address safety concerns, a study was carried out in the NIH III immune deficient mouse model. Long-term data (spanning the life of the animals) revealed no evidence of tumor formation after transplantation.
Advanced Cell Technology, Inc. Prepares IND Filing with the Capability to Produce Stem Cell Lines without the Destruction of the Embryo
Thursday, 12 Mar 2009 08:00am EDT
Advanced Cell Technology, Inc. announced that it is finalizing preparations to file an IND in the second half of this year with the Food and Drug Administration for the Company's retinal pigment epithelium (RPE) cell program for the treatment of diseases of the eye. It has available the only technology that can today produce stem cell lines without the destruction of the embryo. While President Obama recently issued an Executive Order that authorizes expanded federal funding for research using stem cells produced by destroying human embryos, the decision remains controversial as some believe that the Government should not fund the ongoing destruction of human embryos. In the coming months Congress will be debating altering or eliminating the Dickey Wicker Amendment which is at the core of this controversy. Advanced Cell Technology`s stem cell platform offers a compromise on this issue, as described in peer review scientific journals published over the past several years. Over 3000 healthy children have undergone the medical procedure, PGD, which is at the core of ACTC`s technology.
Michael Vlaicu
MiV Investments Inc.
www.StocksHaven.com
President & CEO
"Some people dream of great accomplishments,
while others stay awake and do them"
-----------
By reading MiV Investments Inc. e-mail alerts you agree to the disclaimer, and thereby will not hold Michael Vlaicu accountable for any transactions or decisions you make. It is up to you to do your own due diligence.
MiV Investments Inc. is not paid, compensated or in any way incentivized to report news and developments about publicly traded companies, unless otherwise stated
Part 5
Growing Legislative Support
CA Prop. 71 provides $3.0 billion in funding over 10 years for stem cell research, with preference given to research that is ineligible for NIH funding.
Other states (e.g., NJ, CT, FL, IL, MD, NY, MA, and MO) have passed or proposed similar initiatives.
Political landscape moving in positive direction for stem cell industry starting with President Obama new embryonic stem cell directive initiated January 2009.
Highly Experienced Leadership
Read this article regarding ACTC's Chief Scientific Officer here: http://discovermagazine.com/2008/sep/19-fighting-for-the-right-to-clone/?searchterm=Dr.%20Lanza
"Whether defying the dean of the University of Pennsylvania Schl. of Medicine so he could publish a book on world health or challenging the titans of cosmology, Robert Lanza has never followed the script. It’s no wonder, then, that this renegade doctor would lead the charge into medicine’s most controversial turf: the creation of cloned embryos for therapy and the engineering of spare human parts."
Part 4
Investment Highlights
http://www.advancedcell.com/fact-sheet/
Currently ACT is finalizing preclinical studies for the bio-distribution of our therapeutic program addressing Retinal Degeneration (i.e. AMD or macular degeneration in the eye) and has completed GLP Safety Studies and long-term efficacy studies for the RPE therapy with positive results.
The Company expects spiking studies for the RPE product to be finished in the second half of 2009. ACT expects to file the RPE program IND by the end of 2009.
Working on acquiring funding for Phase II clinical trials for the Company’s Myoblast program, an autologous (meaning “one’s own”) adult stem cell therapy for treating cardiac disease. Historically the Myoblast program successfully completed several Phase I clinical trials.
Published positive results from HG program demonstrating hemangioblasts’ ability to repair vascular damage in animals. Therapy could be effective for treatment of blood and cardiovascular diseases. Anticipates filing an IND in 2010.
Made progress in macular degeneration indication by reporting positive data for RPE cell animal study. Entered into collaboration with Casey Eye Institute for preclinical trials. Completed Pre-IND meeting with FDA. Expects to file IND in 2009.
Developed and demonstrated technique to generate embryonic stems that maintain developmental potential of the embryo and therefore has potential to shift the ethical debate. Announced hESC lines created without destroying an embryo in multiple studies.
Owns or licenses over 380 patents and patent applications related to stem cell therapy.
Large Target Market: Regenerative Medicine has potential to treat diseases of the eye, blood disorders, heart disease, neurodegenerative diseases, liver disease, diabetes, and others.
Led by experienced management team and scientific experts including CEO William Caldwell, Chief Scientific Officer Robert Lanza M.D., VP of Regulatory Ed Mickunas, Senior Director of Manufacturing Roger Gay PhD and Director of Operations Rita Parker.
Part 3
Understanding ACTC's Position
Market Opportunity: Age related macular degeneration (AMD) represents a “tremendous” market opportunity given the size of the patient population and the lack of treatment alternatives. Diseases of the eye affect more than 30 M people worldwide and represent a $20+B market.
Existing therapies only treat the condition and are not curative but palliative and do not regenerate cells of the macula that have been damaged. Additionally, existing therapies only treat Wet AMD not Dry AMD hence leaving a significant unmet need for an effective treatment for the 90% of AMD patients who have the dry variety,
AMD is a common eye disease that leads to deterioration of the macula which is the central area of the retina in the back of the eye, the paper-thin tissue where light-sensitive cells send visual signals to the brain. In particular, sharp, clear, “straight ahead” vision is processed by the macula. Injury to the macula results in the formation of blind spots and blurred or distorted vision. When the macula becomes damaged, many daily activities such as driving and reading become increasingly difficulty,
AMD most often affects individuals over 50 years of age. There are two forms of macular degeneration: dry macular degeneration or wet macular degeneration. Dry AMD takes place when the light-sensitive cells in the macula slowly break down, gradually blurring central vision in the affected eye. As dry AMD gets worse, the patient may see a blurred spot in the center of their vision. As the disorder progresses, and less of the macula functions, central vision is gradually lost in the affected eye. The most common symptom of dry AMD is slightly blurred vision. The affected individual may need more light for reading and other tasks,
Wet AMD occurs when abnormal blood vessels behind the retina start to grow under the macula. As the dry form worsens, some people begin to have abnormal blood vessels growing behind the macula. These new blood vessels tend to be very fragile and often leak blood and fluid (hence ‘wet’ macular degeneration). The blood and fluid raise the macula from its normal place at the back of the eye. Damage to the macula occurs rapidly. With wet AMD, loss of central vision can occur quickly. Wet AMD is also known as advanced AMD. It does not have stages like dry AMD. The wet form is diagnosed in approximately 10 percent of cases; however, it results in 90% of the visual impairment and is considered advanced AMD (there is no early or intermediate stage of wet AMD). Wet AMD is always preceded by the dry form of the disease.
Part2
***Existing therapies only treat the condition and do not regenerate cells of the macula that have been damaged. Plus, existing therapies only treat wet AMD, not dry AMD, leaving a significant unmet need for an effective treatment for the 90% of AMD patients who have the dry variety. The company expects to file an IND for its RPE program by end of 2009. ***
Retinal Pigmented Epithelial Cell Program
http://www.advancedcell.com/rpe-program/
Advanced Cell Technology is currently focused on using its proprietary technologies to generate stable cell lines including retinal pigment epithelium (RPE) cells for the treatment of diseases of the eye, including macular degeneration, which represents a $28 billion dollar market. Age-related macular degeneration (AMD) affects more than 30 million people worldwide and is the leading cause of blindness in people over 60 years of age in the United States. AMD is a disorder that affects the macula of the eye that causes decreased visual acuity and possible loss of central vision. The prevalence of AMD begins to increase after the age of 50. Approximately 15% of people over 75 years of age have the condition.
ACT demonstrated the ability to rescue visual function in rats through implantations of RPE cells derived from human embryonic stem cells. In collaboration with Raymond Lund at the University of Utah, the company performed RPE transplantation into sub-retinal space of rats that naturally become blind in several weeks due to RPE degeneration and photoreceptor death. In the experiments conducted by the company, the rats were injected with embryonic stem-RPE cells into the sub-retinal space of the eye at 21 days after their birth — an age at which photoreceptor degeneration has not yet occurred. As control measures, some rats received injections of cell culture medium alone or were not injected at all. Subsequently, tests for visual function were performed at 60 and 90 days after birth — times at which loss of photoreceptor cell has produced characteristic vision deficits. The results represented a major breakthrough. The injected RPE cells grew normally without forming teratomas. Soon, the rats were able to follow lights with their eyes and attained approximately 70% of the spatial acuity of a normal, healthy rat. Necropsy revealed that the eyes had grown layers of the retinal cells. The experiment demonstrated that animals receiving the human embryonic stem cell-derived RPE cells performed significantly better than medium-only treated (50% improvement), or untreated (100% improvement) controls in visual performance. In addition, the human embryonic stem cell-derived RPE cells did not appear to cause any side effects in the animals. The research was published in Cloning and Stem Cells and was also referenced in Scientific American.
Woodroww - i'm on the subscription email list - hence it wasn't posted to the website yet - but should be by Monday as noted in the email. You can join it for free if you like - i'll cut and paste some of the excerpts b/c the profile posted has a lot of info - GLTY! Partial email posted:
ACTC
The company is in preparation of its first IND filing with the Food and Drug Administration for its retinal pigment epithelium (RPE) cell program for the treatment of various eye diseases. The Company noted that in the next few weeks, it will be completing the preclinical work necessary for filing the IND. To date, no adverse events have occurred in testing. The results will be part of the submission which Advanced Cell expects to submit to the FDA prior to the end of the year.
"We are very pleased with the long-term safety and efficacy data," said Dr. Robert Lanza, ACT's Chief Scientific Officer. "We have carried out pre-clinical studies using these cells in multiple animal models, and to-date have not seen any teratoma formation or untoward pathological reactions. We are optimistic that human embryonic stem cells (hESCs) will serve as a potentially safe and inexhaustible source of RPE for the treatment of a range of macular degenerative diseases."
ACTC just got profiled by stockshaven! :) and it looks pretty damn good - I'm In !
Holy Shiznit Batman!! This volume really is popping - looking forward to a real nice ride today :)
WTWO kicked ass today woot woot :) and expect news out - love the technology - Good Pick!!
Energy is getting more expensive we need this type of technology guys.
I got a feeling....that today's gonna be a good day....woooohoooooo
Google Finance - Look at the most watched stocks :) Buzz Buzz Buzz!!!
SOMETHING IS UP and by tomorrow morning the stock will be as well lol
Gina Gina lol - cook dinner, AND SLEEP! :) lol
CXAC should make for some nice dreams tonight!! :) lol
Did you guys see the volume triple the last half hr of the day?????? I was like :-O
I am extremely looking forward to this week guys - Good Luck to you :)
You're right :)
i forgot we're at the hundredth decimal! lol
carry on then lol -
FYI - GOING TO TAKE A DUMP! FACT
They're paying 1million free shares to OTC Picks for a P & D!!!
Get out while you can -
Company:Paradigm Medical Industries Inc. (PDMI)
End of Day: $ Close:0.006Volume:390,906,355
$ Change:0.002% Change:57.143
Dollar Volume:2,149,985
3 Month :$ High0.006Volume 3m avg:62,991,315
$ Low:0.001% Change 3m:3.871
Dollar Volume 3 m:88,474
Compensation: OTC Picks - one million free trading shares
FDA Medical Device: Non-Invasive Cervical Cancer Detection (OTC:GTHP)
Guided Therapeutics, Inc.
(Public, OTC:GTHP)
Guided Therapeutics, Inc. (OTC:GTHP) contains perhaps one of the most promising medical devices aiming for an annual global $1 billion dollar non-invasive cervical cancer market. Now, lets take a look at how it sits alongside the likes of Nephros (OTC:NEPH) and Imaging3 (OTC:IMGG). Their device LightTouch is a powerful and innovative non-invasive screening device for early detection of cervical cancer. Before getting started, lets dust our shoulders off right off the bat and address and important issue which is rarely discussed. One problem that many rookie investors will argue these days is, the price per share for a stock. Within the small cap industry, everyone seems to be lovestruck by stocks worth under the fifty cent mark, without even considering the current market cap, outstanding shares, and the market potential of the product being developed and/or released for distribution. This is where GTHP comes in, it has one notable difference which separates it from the others, and that is the highly undervalued market cap of GTHP relative to its product. When taking a look at the respective market caps of IMGG ($173M), and NEPH($53M), it then becomes evidently clear that GTHP’s highly conservative (11M) will undoubtedly follow in the foot steps of these golden nuggets. GTHP’s product, LightTouch is indeed impressive when taking into consideration that there exists only two screening options for cervical cancer detection in the Pap smear and HPV tests, which are painful, and highly inaccurate procedures. GTHP had its product tested on over 3000 women to date, and over 1900 in a critical FDA pivotal clinical trial on route to providing a 46% improvement over the Pap smear test, and thus leading to the company receiving a multi-million dollar grant from the National Cancer Institute on 10/5/09. Based on the outcome of the study, GTHP plans to submit the trial results to the FDA as part of the Premarket Approval (PMA) application for the LightTouch.
Undervalued and high potential couldn’t be more evident for GTHP. A company that with its recent $2.5M grant from the National Cancer Institute has come a long way from bankrupcy fears stated in the 08/18/2009 10-Q. Oh, and it doesn’t hurt when 81% of women want the LightTouch to replace the current conventional Pap smear. If you’re wondering why they mention SpectRx in the study, it is because that was the old name prior to their name change to Guided Therapeutics.
About Guided Therapeutics, Inc.
Guided Therapeutics, Inc. is a medical technology company developing and providing products for the non-invasive cervical cancer detection and diabetes markets. The Company uses its technologies to develop non-invasive diagnostic devices, such as its cervical cancer detection product. The Company’s products in development cancer detection are based upon its biophotonic technologies. The Company’s technology, including products in research and development, includes biophotonics technology for the non-invasive detection of cancers, including cervical cancer, and methods of measuring biologically important molecules in blood and interstitial fluid, such as glucose, alcohol and cortisol using specialized sensors and collection devices.
LightTouch™ Non-invasive Cervical Cancer Detection
LightTouch™, under development by Guided Therapeutics, is being designed as a new non-invasive test that has the potential to significantly improve the early detection of cervical precancers and cancers. LightTouch™ is designed as a fast, painless test – that unlike Pap smears and HPV testing – does not require a tissue sample or the delay of laboratory analysis. Early detection of cancer and precancers greatly improves survival, and LightTouch™ is designed to help preserve the reproductive health of women.
LightTouch™ uses proprietary technology to identify cancers and precancers quickly by analyzing light reflected from the cervix. LightTouch™ creates an image of the cervix for the doctor that highlights the location and severity of disease. The technology distinguishes between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level.
A pre-pivotal clinical study of LightTouch™, sponsored by the National Cancer Institute indicated that the non-invasive test could reduce by 55% the number of unnecessary follow-up procedures as a result of false positive Pap test results. The potential savings to the U.S. healthcare system could be as high as $181 million annually if the technology is widely adopted.
According to published reports, cervical cancer is the third most common cancer among women worldwide. Globally, there are approximately 471,000 cases of cervical cancer diagnosed annually and approximately 233,000 deaths per year. Approximately 60 million Pap tests are performed annually in the United States.
Cervical Cancer Market
In the U.S. alone, over $6 billion is spent annually on the screening, diagnosis and treatment of women with cervical cancer. Diagnosing cervical cancer is often a long and uncertain process, requiring repeat visits by anxious patients. Approximately three million colposcopy procedures are performed annually, with many repeat exams aimed at arriving at a definitive diagnosis. The U.S. colposcopy market alone is approximately $1 billion annually.
Cervical cancer is the sixth most common form of malignancy in U.S. women with 10,000 new cases per year. An additional 600,000 women are identified each year as having pre-invasive cervical cancer. Early detection of these precancerous conditions allows clinicians to treat patients more effectively, less expensively, and with fewer lasting health effects. Currently, women with abnormal Pap tests are diagnosed with a colposcope, a decades-old, low-powered binocular microscope technology, which provides only a limited visual assessment of the cervix. In fact, a recent large-scale National Cancer Institute-sponsored clinical trial demonstrated that colposcopy failed to detect 33% of high-grade precancerous lesions in women referred with questionable Pap results.
More than three million U.S. women have abnormal Pap tests each year, and they typically undergo a series of repeat, stressful and expensive diagnostic tests. For women with precancerous lesions, the long diagnostic cycle can allow the disease to progress and develop into invasive, life-threatening cancers. By providing a more definitive test, the LightTouch test will allow clinicians to more effectively manage and treat millions of women who are at risk of cervical cancer.
Innovative Advantage
The GT LightTouch technology systematically and rapidly scans the cervix to identify cancer and pre-cancer painlessly and non-invasively, by analyzing the wavelengths of light reflected from cervical tissue. The technology distinguishes between normal and diseased tissue, by detecting biochemical and morphological changes at the cellular level. Unlike Pap or HPV tests, the LightTouch test does not require a tissue sample or laboratory analysis, and is designed to provide results immediately. The technology is designed as a device employing a single-use disposable patient interface.
FDA News
*The following is provided via BioMed Reports FDA Calendar
Biophotonics Science
Biophotonics is the science of generating and harnessing light to image, detect and manipulate biological materials.
Biophotonics is used in medicine to study tissue and blood at the macro (large-scale) and micro (very small scale) organism level to detect, diagnose and treat diseases in a way that are non-invasive to the body. (Courtesy of NSF Center for Biophotonics Science and Technology)
The LightTouch™ Non-invasive Cervical Cancer Analyzer uses light to detect both physical and chemical changes in tissue that may be markers of cervical disease.
Patents
The company truly has a vast arsenal of patents, which should provide a comforting feeling as to their diligent work during the research and development of their products.
US 7,006,220 Apparatus and method for determining tissue characteristics
US 6,975,899 Multi-modal optical tissue diagnostic system
US 6,870,620 Apparatus and method for determining tissue characteristics
US 6,590,651 Apparatus and method for determining tissue characteristics
US 6,577,391 Apparatus and method for determining tissue characteristics
US,6,400,875 Method for protecting a fiber optic probe and the resulting fiber optic probe
US 6,226,541 Apparatus and method for calibrating measurement systems
US 6,192,734 Disposable Calibration Target
US 6,045,502 Analyzing system with disposable calibration device
US 6,055,451 Apparatus and method for determining tissue characteristics
US 6,002,482 Disposable calibration device
US 5,924,981 Disposable calibration target
US 5,860,421 Apparatus and method for calibrating measurement systems
US 5,792,049 Spectroscopic system with disposable calibration device
US 5,582, 168 Apparatus and methods for measuring characteristics of biological tissues and similar materials
US 5,203,328 Apparatus and methods for quantitatively measuring molecular changes in the ocular lens
Latest News Updates
Published Study Shows 81% of Women Want SpectRx Non-Invasive Cervical Cancer Test to Replace the Standard Pap Smear
Eighty-one percent of women tested with SpectRx’s (OTCBB: SPRX) non-invasive cervical cancer detection prototypes wanted the test to be used as a replacement for the invasive Pap test, according to a study published in the current edition of the Journal of Lower Genital Tract Disease. Additionally, 87 percent of women who took the SpectRx test would recommend it to a friend who is to undergo an exam for cervical disease. More than 96 percent of women surveyed favored the SpectRx test as a method for locating the presence of disease and reducing the number of biopsies. Additionally, the study reported that 85 percent of participants wanted their doctor to have the test and 91 percent wanted their insurance company to pay for it. Source of news
Guided Therapeutics, Inc. Reports Preliminary Findings from FDA Pivotal Clinical Trial
Guided Therapeutics, Inc. (GT) (Pink Sheets: GTHP) today announced that its LightTouch™ non-invasive cervical cancer detection technology properly identified cervical disease missed by Pap tests and conventional pathology in a multi-site Food and Drug Administration (FDA) pivotal clinical trial. Based on the outcome of the study, GT plans to submit the trial results to the FDA as part of the Premarket Approval (PMA) application for the LightTouch.
“We are very pleased that the results of the study indicate that the LightTouch is capable of discovering disease that may be missed by conventional cervical disease detection,” said Mark L. Faupel, Ph.D., GT President and CEO at the Southeastern Medical Device Association annual conference in Atlanta. “Based on the study results, we believe that our technology also demonstrates the capability to detect cervical disease early, when it is most effectively treated.”
Since the pivotal trial began, more than 1,900 women were tested to demonstrate the technology’s safety and efficacy in detecting cervical disease, including an arm of the study that assessed effectiveness of an investigational commercial version of the device and single-use disposable.
The study protocol indicated that all subjects were referred after undergoing a Pap test, or had some other risk factor that fulfilled the referral criteria of the study. Each subject was tested with the LightTouch investigational device and underwent an additional Pap test, colposcopic exam and biopsy. Two generations of the investigational LightTouch were used in the trial.
Preliminary results from the study showed that the LightTouch performed better than the Pap test. The investigational commercial version of the LightTouch detected approximately 46 percent more cervical disease than the Pap test – a statistically significant improvement.
The company expects to complete analyzing the study results and present the findings to the FDA in the second quarter of 2009. Source of news
Guided Therapeutics, Inc. and Konica Minolta Opto, Inc. to Jointly Develop Cancer Detection Products
Guided Therapeutics, Inc. (GT) (Pink Sheets: GTHP) today announced that it has entered into an agreement with Konica Minolta Opto, Inc. (KMOT) of Tokyo to co-develop non-invasive cancer detection products. The new development agreement follows two years of collaborative preparations to identify large market opportunities that would benefit from GT’s proprietary technology.
The new products, for the detection of lung and esophageal cancer, are based on GT’s LightTouch™ non-invasive cervical cancer detection technology, which is undergoing the U.S. Food and Drug Administration’s premarket approval process. Lung cancer is the most prevalent cancer in the world and esophageal cancer ranks just below cervical cancer in newly diagnosed cases, according to the World Health Organization (WHO).
“We look forward to working with Konica Minolta to bring these products to market and build upon our cervical cancer detection platform,” said Mark L. Faupel, Ph.D., President and CEO of GT. “Our primary focus continues to be completing the FDA process and preparing for launching LightTouch internationally. Now that this work is largely completed, we can begin the planned expansion of our product pipeline. We are fortunate to have available the considerable resources and assistance of Konica Minolta to help accomplish the product line extensions.”
Technical Chart Analysis ( Click image to enlarge )
These past six months have seen a substantial increase in volume for GTHP as it appears to be gaining momentum for a healthy jump in share price. This week, the price clearly exceeded the corresponding top trend-line (dashed Blue line on the chart) of the well established price channel that has been in control for over two years. This move indicates the price channel (Blue lines on the chart) may have expanded and the previous top trend-line (dashed Blue line) now appears to be the new mid-line. Typically, one doubles the height of the previous channel and this could indicate the new top trend-line is near the .83 cent level. In fact, the price closed right on the 3/4 trend-line of the Blue channel today. This is the third time the price has breached this trend-line and, as is usually the case, the third time is the charm to finally break up and above the line. Currently, there appears to be a resistance level around .70 cents. However, given the ¾ trend-line support at .66 cents and the ever increasing volume these past 6 months (especially the heavy volume this week indicated by the Grey volume bars), the interest in this company’s recent activity seems very positive and this stock is poised to carry on into the upper level of the freshly expanded price channel and beyond. As always, it’s good to keep in mind that the price has reached over 1 dollar before (a 59% increase from today’s closing price) and indicates the price channel is much taller than the conservative channel currently on the chart.
Overall Sentiment
What you have with GTHP is a highly undervalued, high potential company. Take into consideration that this company’s current market cap is hovering around a conservative $10M. Their product LightTouch targets an annual global $1 billion dollar non-invasive cervical cancer market, and has been tested on over 3000 women, 1900 in a critical FDA pivotal clinical trial on route to providing a 46% improvement over the Pap smear test, and thus leading to the company receiving a multi-million dollar grant from the National Cancer Institute on 10/5/09. Factor in the fact that eighty-one percent of women tested wanted it to be used as a replacement for the invasive Pap test, according to a study published in the current edition of the Journal of Lower Genital Tract Disease. Add to that their recent $2.5M grant from the National Cancer Institute which now leaviates their ongoing concerns of potential bankruptcy, and you have yourself one of the most undervalued medical device plays within the small cap bio-tech industry.
———–
Disclosure: Short term position in GTHP
———–
By reading StocksHaven Investments company profiles you agree to the disclaimer, and thereby will not hold Michael Vlaicu accountable for any transactions or decisions you make. It is up to you to do your own due diligence.
StocksHaven Investments is not paid, compensated or in any way incentivized to report news and developments about publicly traded companies, unless otherwise stated.
Man, I love John Wayne!!! Zeng Zeng Zeng! To the moooon :)
Mr Wizard,
Thanks for providing this awesome news - how long do you think ZENG will go till people actually take notice? 1st PR or the way it happened with GVBP by the 4th PR - I think (Opinion Mine) it will be sweeeet regardless. but I definately don't want to be left holding the bag when PRs run out. PSC is a good source of PR though so i'm not worried.
|What a day for a daydream....
Honestly guys; if this momentum continues and we do break that .024 resistance that next resistance of .04 will be backed by huge momentum - accept & expect the sells on the way and if you could buy more into your position.
The Chart analysis posted earlier was superior.
If PSC goes ahead and promotes it will run and not look back; 8 PRs expected and paid in cash :) :) :) lol
What a day for a day dream... (if you missed it it's the NY Lotto commercial)
NYPharmer1
This is a follow up article i posted to SNGX. Do your Due lol There is a video posted as well as a Conference Call. So go to the site to check it out.
Why Soligenix Will be Successful (OTC:SNGX.OB)
Date October 6, 2009
Listen to this article. Powered by Odiogo.com
Soligenix, Inc.
(Public, OTC:SNGX)
Soligenix truly is a magnificent company, its no wonder the government also favours it so much by pouring in grants and funding. It stands tall amongst the other struggling small cap biotechs, and even after changing its company info from DORB Pharma (OTCORB.OB) to Soligenix (OTC:SNGX.OB), it remains ahead of the pack while the others are still searching to make a name for themselves. After profiling the company the first time around, StocksHaven Investments felt it was necessary to paint a more clear picture as to what really makes this company not just a valuable investment, but rather a great one at that. The true potential lies in the company’s liquidity and ability to fund R&D, clinical trials and other important distributional aspects that many other small biopharmas lack. Many investors also may be aware of the main product OrBec which tends to be the company’s standout, however it is important you are also tunned to Soligenix’s BioDefence side of the table. The main scope or aim for this analysis is derived from the company’s conference call at the Rodman & Renshaw convention, where this article will depict and restate the potential target markets and current state of the company within the present and future. With the vaccine market set to double within the next five years, and products with market potentials in excess of $500M, this current state of $51.9M market cap won’t last much longer as investors begin to dig up this undiscovered story.
What’s important to note about this company, is that due to the fact that they have already submitted an NDA, they do not need to resubmit it — thus making FDA approval process significantly faster and more focused. The NDA is in place, and they simply have to respond to an action letter, so with that response which is class II, it is a 6 month review cycle.
For those who are new to this company, we suggest you read the company profile here.
Presentation at Rodman & Renshaw
Christopher J. Schaber, Ph.D., President and Chief Executive Officer, presented at the Rodman & Renshaw 11th Annual Global Investor Health-care Conference on Thursday, September 10, 2009 in the Spellman Salon of the New York Palace Hotel, New York.
*Press play to listen
Key Highlights of the Conference
* Potential for exponential growth with approval of OrBec
* Positive confirmatory phase III trial cleared by FDA & EMEA
* Clean cap structure with no debt or preferred stock oustanding
* Completed $30M partnership for North America with Sigma-Tau Pharmaceuticals
* OrBec addresses potential $200M GVHD market, as well as $500M for treatment of other diseases/complications
* Biodefence side is funded entirely by government grant money
* Worldwide leader in Ricin toxin vaccine development
* Not only treating acute GVHD, but also aiming to prevent it in a phase II study which will be completed by year end
* Experienced management team – see here for more details
* Acute GVHD has unmet needs, no treatments currently approved
* OrBec has obtained track Oprhan status from the FDA
* Risk and Benefit Analysis of OrBec: Significant reductions in mortality thus far, far better safety than placebo
* Trials done at multiple centers with 129 patients for phase III, prior to the confirmatory one
* Have experience with filing NDA, stated FDA required additional information and a confirmatory phase III
* Went through highly informative assessment with the FDA very similar to previous trial with 166 patients
* Partnerships throughout the world with the ability to generate revenue once OrBec is approved
* Marketing partnership already established aimed at distributing to Canada, USA, and Mexico
* 35% Royalty on net sales that comes back to Soligenix
* $10M in milestones, with $1M expected upon enrollment of first patient which is imminent
* Other products: Radiation, Prostate Cancer, and Crohn’s Disease have potential markets in excess of $500M
* Rivax vaccine for Ricin: Threat is real
* In 2008 Ricin exposure in Las Vegas motel
* In 2007 FBI terrorism report, Ricin and Anthrax posed biggest concerns as forms of Bioterrorism attacks
* World leader in Ricin vaccine R&D
* Received in excess of $11M in NH funding to date
Overall Sentiment
“Vaccines are quickly becoming an attractive investment option because the market will double during the next five years, because the products aren’t readily reproduced by competitors and because of the investment required to build vaccine plants, Viehbacher said.” News source here
What you have in Soligenix is a company with really diversified portfolio with a Biotherapeutics, and a Biodefence side, which is highly funded by investors, institutions and government grants. This makes them stand apart from many other small biotechs which are struggling with cash burn and ongoing conerns towards future operations. A little patience can go a long way with this FDA play.
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Disclosure: Short term position in SNGX
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Not for nothing - ZENG soared today - i expect nothing less than continued positive momentum.
I bought @ .0195 bc i was skeptical with a portion of my funds. As soon as it broke 2 i bought the rest - scared the crap out of me as it fluctuated but who wouldn't take profits if you were in 50% earlier.
I read the chart;
MACD crossed - RSI not even near overbought (closer to sold); it hit bottom with upward momentum and it's 90% bottomed. (10 cents 3 months ago)
We have the PSC contract which was paid in CASH, CE is imminent & 8 PRs to follow - Give me a break :) 0 Buy or Lose! You Choose (quote mine)
and if i may -
We have pretty promising evidence that
1) PSC has already been compensated $150K (cash) to promote ZENG.
2) The CE should be lifted by the end of this week. (if not tomorrow)
3) It's 90% down from it's 10 cent high 3 months ago and seems to have bottomed and picked up the momentum.
Look forward to a fruitful day tomorrow.
ok, So the stock was @ roughly 10 cents a little less than 3 months ago, you look at the chart and you can't but notice how well poised it is to start an upward momentum; today it crossed the MACD; broke through 2 cent resistance; is a lot closer to the oversold mark than overbought on the RSI and is simply exploding in volume - ohhh and i forgot to mention it popped 50% by end of day!!!
thanks for the gains today
who could RESIST my ZENG! ! ! :)
I TELL YOU HONESTLY! EVEN IF IT DOESN'T BREAK through .025 cents today it wil by no means - i'm holding by end of next week at least - i got a feeling that tonight's gonna be a good night that tonight's gonna be a good good nite.... :) wooohooooo
GO BABY GO BABY GO - we broke 2 loool :)))
ALL THAT GLITTERS IS GOLD!!!
DEFINATELY CE WILL BE LIFTED EVEN IF NOT PSC HAS ITS WAYS!
Not for nothing - but if this stock was @ 12 cents a month ago it makes absolutely no sense to deny it will pop once PSC promotes this stock!!! And you know they will pump it!!!
THE LINK - SPONGEWORTHY - NYPOST
http://www.nypost.com/p/news/business/not_spongeworthy_ZZZ1QlWllnBaSYuVjqYysK
Hi All,
I just bought into EVFL & signing onto IHUB - (have always been a lurker) Looking forward to great things with this stock as well as being a member. GLTA!
NYPharmer1