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Is there any info as to whether Sue still had an intact Bruch's Membrane (BrM)? I would have thought that an intact BrM was a patient's requirement to the trial selection.
"I think that after injecting Sue who had 20/500 and improved to 20/320"
Is there anyone on this board that can discuss technical medical reason(s) as to how Sue improved and yet new engraftment has not been identified. Is the FDA waiting for an explanation before allowing AMD patient 2?
It has not been stated what time the 10Q will be released. Possible anytime tomorrow or even AM on Wed Feb 15. Investors will need to make their decision as to buy, sell, or hold. IMO the 10Q may not be as important as to what Elite mgmt will say at the CC.
Elite Pharmaceuticals, Inc. to Discuss Third Quarter 2012 Results of Operations on Wednesday, February 15, 2012 02/13 08:30 AM
NORTHVALE, N.J., Feb. 13, 2012 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. (ELTP:$0.109,0$-0.001,0-0.91%) , a specialty pharmaceutical company dedicated to developing and commercializing oral sustained and controlled release product formulations and generics with high barriers to entry, announced today the Company will host a conference call on Wednesday, February 15, 2012 at 2:00 PM EST to review the third quarter results of operations and provide an update on recent business developments. Company executives will also conduct a question and answer session following their remarks.
To access the conference call:
Domestic callers: (800) 346-7359
International callers: (973) 528-0008
Conference Entry Code: 98840
A digital telephone replay will be available approximately one hour after the conclusion of the call for two weeks until February 29, 2012 by dialing:
Domestic callers: (800) 332-6854
International callers: (973) 528-0005
Conference entry code: 98840
ACT Announces Third Patient with Stargardt’s Disease Treated in U.S. Clinical Trial with RPE Cells Derived from Embryonic Stem Cells
Final Patient from First Cohort in Phase I//II Trial Using hESC-Derived RPE Cells 02/13 08:00 AM
MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. (ACTC:$0.109,0$0.002,01.87%) , a leader in the field of regenerative medicine, announced today the dosing of third patient in its Phase 1/2 trial for Stargardt’s macular dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The patient was treated on Monday (Feb. 6) by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA) and retina division chief at UCLA’s Jules Stein Eye Institute. The outpatient transplantation surgery was performed successfully and the patient is recovering uneventfully.
“With the treatment of this third Stargardt’s patient at Jules Stein Eye Institute, we have now completed the treatment of the first cohort of patients under our clinical protocol for phase I/II of our U.S. SMD trial,” said Gary Rabin, chairman and chief executive officer of ACT. “We will continue to regularly monitor the three SMD patients in this trial, and by early spring anticipate review of their progress and safety-related data by the Data and Safety Monitoring Board (DSMB). With approval of the DSMB, we would then advance to the next cohort of patients and administer a higher dosage of RPE cells. In the context of all three trials we have running, this patient is the fifth person worldwide to be treated with our hESC-derived RPE cells. To date, there have been no complications or side effects due to the RPE cells, and we remain cautiously optimistic that our ongoing clinical programs will demonstrate the safety and tolerability of ACT’s stem cell-derived RPE cells.”
Each of the three clinical trials being undertaken by the company in the U.S. and Europe will enroll 12 patients, with cohorts of three patients each in an ascending dosage format. These trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with SMD or dry age-related macular degeneration (dry AMD) at 12 months, the study’s primary endpoint. Preliminary results relating to both early safety and biological function for the first two patients in the United States, one SMD patient and one dry AMD patient, were recently reported in The Lancet. On January 20, 2012, the first SMD patient to be enrolled in the Company’s U.K. clinical trial was treated at Moorfields Eye Hospital in London
Crawford
Very interesting comment.
"I have a feeling that Dr. Lanza already knows that he is going to succeed and that is why he funded the trials himself."
IYO. Are the criticisms of Dr. Lanza's share sales unjustified? Could Dr. Lanza's selling of shares be a means by which the monies, part or all, are used to provide contributing expense actions in support of ACT's programs for discovery, patents, and clinical trials.
Carbon to Diamonds! Inventors Hall of Fame.
http://www.invent.org/hall_of_fame/419.html
Not looking for the multi-carat fashion diamonds. However ELTP heading for big revenues!
Those with 10% or higher ownership have to file SEC Form 4. These buy and sell actions are considered insider-trading.
http://www.secform4.com/insider-trading/1053369.htm
With 4.9 mil shs last and most of it being accumulated at $0.11, it has been a strange week with each day closing at $0.11
Perhaps Trellus is selling off their remaining shs and with less than 5% ownership Trellus would not have to file a Form 4.
Hopefully there will be a PR early this week as to the date of the CC.
Last year IR had a PR on Feb 10/2011 announcing the Feb 14/2011 CC. Have to wonder if IR will issue a PR pre-announcing the date.
Does anyone know on what date the CC will be?
In 2012 Sirius will continue to reduce debt followed by an inevitable credit rating upgrade which in turn will allow refinancing of remaining debt at a lower interest rate.
For myself it is not the moral issue.
When ASC are used it is best that the ASC be AASC namely autologous. IMO STEM's technology is extremely dangerous as there is no natural engraftment site for these foreign CNS but rather to remain in some limbo state.
IMO it is best to stay 100% with ACT's technologies. ACT also has autologous ASC expertise.
Major differences between STEM and ACT technologies
STEM's HuCNS-SC "adult" cells technology would be an attempt to "preserve human retinal photoreceptors" whereas ACT's hESC RPE cells is an attempt to "restore and preserve human photoreceptors".
STEM's HuCNS-SC "adult" cells are apparently sourced from aborted fetuses. If this is so, this would be very controversial IMO.
STEM's HuCNS-SC "adult" cells remain in some kind of limbo state when injected as "immature phenotype".
http://onlinelibrary.wiley.com/doi/10.1111/j.1460-9568.2011.07970.x/abstract
Abstract
Stem cells derived from the human brain and grown as neurospheres (HuCNS-SC) have been shown to be effective in treating central neurodegenerative conditions in a variety of animal models. Human safety data in neurodegenerative disorders are currently being accrued. In the present study, we explored the efficacy of HuCNS-SC in a rodent model of retinal degeneration, the Royal College of Surgeons (RCS) rat, and extended our previous cell transplantation studies to include an in-depth examination of donor cell behavior and phenotype post-transplantation. As a first step, we have shown that HuCNS-SC protect host photoreceptors and preserve visual function after transplantation into the subretinal space of postnatal day 21 RCS rats. Moreover, cone photoreceptor density remained relatively constant over several months, consistent with the sustained visual acuity and luminance sensitivity functional outcomes. The novel findings of this study include the characterization and quantification of donor cell radial migration from the injection site and within the subretinal space as well as the demonstration that donor cells maintain an immature phenotype throughout the 7 months of the experiment and undergo very limited proliferation with no evidence of uncontrolled growth or tumor-like formation. Given the efficacy findings and lack of adverse events in the RCS rat in combination with the results from ongoing clinical investigations, HuCNS-SC appear to be a well-suited candidate for cell therapy in retinal degenerative conditions.
###
IMO best to remain with ACT until more is learned about the STEM HuCNS-SC "adult" cells technology.
"STEM apparently is doing EXACTLY the same thing as ACTC"
Not exactly
http://finance.yahoo.com/news/StemCells-Inc-Receives-FDA-pz-957812600.html?x=0
"We have published the preclinical evidence demonstrating that our human neural stem cells might offer a safe, effective and simple approach to treating AMD and other retinal diseases," said Stephen Huhn, MD, FACS, FAAP, Vice President and Head of the CNS Program at StemCells, Inc. "Our approach is to provide durable protection of photoreceptors, thereby preserving vision, as opposed to approaches that aim to replace photoreceptors or the retinal pigmented epithelial cells. Furthermore, our preclinical data supports our hypothesis that we can achieve clinical benefit with a single transplant in AMD patients."
Mon Jan 30, 2012
16:03:05 0.1213
15:58:53 0.1217
HOD so far is 0.1238
Do we need to close above 0.1217?
0.122 intraday or close matter?
What is the significance of 0.122?
This is the 2nd patent
http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=1&p=1&f=G&l=50&d=PG01&S1=%22ELITE+LABORATORIES,+INC%22&OS=%22ELITE+LABORATORIES,+INC%22&RS=%22ELITE+LABORATORIES,+INC
This patent has the actual claim for the thickness weight and, as well, can be submitted directly to the European Patent office.
1. A method of preventing the abuse of an oral dosage form of an opioid agonist, comprising: forming an oral dosage form by combining: a first pellet comprising an opioid agonist; and a second pellet comprising: a biologically inert pellet; an opioid-antagonist layer coated on the biologically inert pellet, wherein the opioid-antagonist layer comprises a therapeutically effective amount of an opioid antagonist; and a non-releasing membrane coated on the opioid-antagonist layer, wherein the non-releasing membrane comprises a water-retardant polymer that is a EUDRAGIT.RTM. NE 30D or NE 40D non-ionic poly(ethyl acrylate-co-methyl methacrylate), wherein the at least one water-retardant polymer constitutes about 30% to about 50% by weight of the solids content of the oral dosage form; wherein less than a therapeutically effective amount of the opioid antagonist is released from the dosage form after about 14 to 24 hours in vitro, when measured by the USP Basket method at 100 rpm in 900 ml of water at 37.degree. C.
Also OCR's stem cells are adult bone marrow source, ASC. In addition OCR is strongly against Embryonic ESC.
***The stem cells used in the study were derived from bone marrow. The cells were not taken from human embryos, which is a practice many people abhor.
“Embryonic stem cells are old news, out of fashion and obsolete,” said Jared Shields, a clinical research facilitator at Salt Lake City-based Optimum Clinical Research, the firm conducting the study. ***
SiriusXM will hold a conference call at 8:00 am ET on Thursday, February 9, 2012 to discuss these results. Investors and the press can listen to the conference call via the company's website, www.siriusxm.com, and on its satellite radio service by tuning to Sirius channel 94 or XM channel 145. The call will also be available on the Sports Zone channel on SiriusXM Internet Radio as well as through the SiriusXM Internet Radio
Buy back debt thereby raising credit rating IMO
PreMkt up $2.10/$2.11. Anticipation of CC. Buyback?