DAVID GRANOVSKY

Archive for August, 2009|Monthly archive page

Southampton surgeons – stem cell technique repairs bones

In VICTORIES & SUCCESS STORIES on August 31, 2009 at 11:28 am

Southampton surgeons develop technique to repair bones

11:19am Monday 31st August 2009

SURGEONS from Southampton have developed a pioneering bone repair technique that could end the need for artificial hip replacements.

Six people have undergone the procedure which uses a their own stem cells to repair damaged hip joints. Only one operation has failed.

via Southampton surgeons develop technique to repair bones (From Daily Echo).

Top 10 Signs You Might Not Be A Libertarian – #4

In STEM CELLS IN THE NEWS on August 31, 2009 at 11:26 am

Aug 30, 2009 at 06:00:45 AM PDT

Notice a propensity of newly minted Libertarians showing up lately? Perhaps it’s just coincidence their ranks swelled in inverse proportion to George Bush’s approval rating, ditto that so many are mouthing traditional conservative talking points. But what about the everyday gun toting townhall screamers and taxcutters and deficit hawks we see on cable news: are they really libertarian as so many claim, or just conservatives in glibertarian clothes? Here’s a few warning signs.

  1. You’re probably not a Libertarian if you believe the federal government should remove safety standards and clinical barriers for prescription and OTC medications while banning all embryonic stem cell research, somatic nuclear transfer, RU 486, HPV and cervical cancer vaccination, work on human/non human DNA combos, or Plan B emergency contraception.

New breakthrough ‘could prevent hereditary diseases’ – Health | Bounty

In SCIENCE & STEM CELLS on August 27, 2009 at 8:44 pm

New breakthrough ‘could prevent hereditary diseases’

Couples could be able to have their own biological child, but have the embryo altered at the very early stages to ensure it is born with no hereditary medical conditions.

At least that is what a new research breakthrough has suggested, after experiments were successfully carried out on pregnant monkeys at the Oregon National Primate Research Centre and Oregon Health and Science University.

The proposed procedure could see scientists remove the nucleus from extracted maternal eggs that carry the DNA defects that cause certain diseases and transplant it into a healthy egg, which would then be transplanted back into the pregnant woman’s uterus.

Commenting on the findings, Professor Ian Wilmut, head of the Medical Research Council’s Centre for Regenerative Medicine at the University of Edinburgh, told the Times: “This brings us an important step nearer to being able to prevent the birth of children with a particular type of inherited disease.”

Meanwhile, scientists at the University of Auckland in New Zealand recently revealed that women who gain too much weight while pregnant could give birth to children who enter puberty at a younger than usual age.

via New breakthrough ‘could prevent hereditary diseases’ – Health | Bounty.

Geron Gives Reason for FDA Hold; Shares Rise

In BUSINESS OF STEM CELLS on August 27, 2009 at 1:07 pm

Geron Gives Reason for FDA Hold on Stem-Cell Trial; Shares Rise

By Rob Waters

Aug. 27 (Bloomberg) — Geron Corp. rose as much as 5 percent in Nasdaq trading after saying a hold placed by U.S. regulators on its plan for the first human embryonic stem-cell study was due to “non-proliferative” cysts in test animals.

The Food and Drug Administration cleared Geron in January to test its stem-cell treatment in patients with spinal cord injuries. The company, based in Menlo Park, California, announced the regulatory hold on Aug. 18.

The microscopic cysts seen in an early experiment in a few animals that received the cell-based treatment, GRNOPC1, were found in larger numbers of animals in a recent study. The cysts weren’t linked to complications, the company said in a statement today. A more recent study of rats using a new batch of test chemicals showed no cysts, the company said.

Stephen Brozak, an analyst with WBB Securities LLC in Westfield, New Jersey, said investors would be reassured that the animals didn’t develop a type of tumor known as a teratoma.

“I think it provides people with a reasonable explanation,” Brozak said. “Everybody was afraid of the T- word, teratomas, and it clearly wasn’t that.” Brozak has a “strong buy” rating on the shares.

Geron rose 12 cents, or 1.7 percent, to $7.05 at 11 a.m. New York time in Nasdaq Stock Market composite trading, and traded as high today as $7.28. The shares fell 10 percent after the company announced the FDA’s hold on Aug. 18.

via Geron Gives Reason for FDA Hold on Stem-Cell Trial; Shares Rise – Bloomberg.com.

‘Hedgehog’ Pathway May Hold Key To Anti-cancer Therapy

In ALL ARTICLES on August 27, 2009 at 10:16 am

‘Hedgehog’ Pathway May Hold Key To Anti-cancer Therapy

hedgehog

ScienceDaily (Aug. 26, 2009) — Scientists in Switzerland have discovered a way to block the growth of human colon cancer cells, preventing the disease from reaching advanced stages and the development of liver metastases. The research, published in EMBO Molecular Medicine, shows that blocking the so-called Hedgehog-GLI pathway can prevent the growth of tumours, metastatic lesions and cancer stem cells, the cells thought to lie at the root of cancer growth…

via ‘Hedgehog’ Pathway May Hold Key To Anti-cancer Therapy.

Ameritrade stalls trading of BIEL & ASFX

In BUSINESS OF STEM CELLS on August 27, 2009 at 8:59 am

Traders angered and confused after Ameritrade stalls trading of two healthcare OTC stocks

August 26, 2009

If your biotech penny stock lost momentum in the last 24 hours, your trading platform may have something to do with it.

Investors following two increasingly popular biomed stocks are reacting angrily after Ameritrade’s decision to halt trading of American Scientific Resources (PINK SHEETS:ASFX) and BioElectronics Corporation (OTC:BIEL). Both stocks had been increasing in both volume and price per share in recent days, but got flagged by the widely used securities brokerage service which resulted in customers finding themselves unable to purchase shares.

Some day traders who use the platform, found themselves locked out after trading out of their positions while taking advantage of some of the wild swings that these penny stocks experience. They were reportedly allowed to trade out of the shares, but not allowed to buy back in. Prices for both stocks experienced pull back as investors pushed the panic button amid the confusion.

via American Chronicle | Traders angered and confused after Ameritrade stalls trading of two healthcare OTC stocks (OTC:BIEL).

Stemedica Selected by World Stem Cell Summit…

In BUSINESS OF STEM CELLS on August 27, 2009 at 8:52 am

Stemedica Selected by World Stem Cell Summit to Present Scientific Discoveries

SAN DIEGO, Aug. 27 /PRNewswire/ — Stemedica Cell Technologies , Inc., (“Stemedica”), a world leader in stem cell research and manufacturing (a licensed manufacturer of clinical grade biological products as licensed by the State of California Food and Drug Branch) continues to advance the stem cell industry with the presentation of two of its latest scientific discoveries at the 2009 World Stem Cell Summit.
Neural Stem Cell Potency Evaluation Model (Chickens)

The first discovery…submitted by Chih-Min Lin, PhD is entitled, “Chicken Embryonic Brain: A Model for Testing Neural Stem Cell Potency.” This Neural Stem Cell Evaluation Model determines the potency of neural stem cells and quickly assesses their ability to migrate and engraft inside the developing brain. Stemedica’s technology allows neural precursors to be distinguished at various stages of their maturation, providing timely and cost effective verification of neural stem cell potency in vivo.

Wound Healing Associated Protein Analysis

The second finding…Ludmila Kharazi, MD, PhD…“Up-Regulation of Wound Healing Associated Proteins in Long-Term Culture of Human Keratinocyte Precursor Cells.” Dr. Kharazi’s work demonstrates that long term cultivation of human keratinocytes in serum free, low-Ca++ media (SFM) leads to the increased expression of genes for wound healing-associated proteins such as fibronectin, metalloproteinase (MMP9, MMP10), and tissue-type plasminogen activator (TPA). The purpose of Dr. Kharazi’s work was to determine how the propagation of human skin keratinocyte precursor cells (KPC) in SFM to clinically significant numbers will affect their ability to produce fibronectin and other wound healing associated proteins.

The 2009 World Stem Cell Summit is being held in Baltimore, Maryland from September 21st – 23rd. Presented by the Genetics Policy Institute, the 2009 Summit is hosted by Johns Hopkins University and other leadership organizations from within the stem cell industry, bringing together more than 1,200 researchers, clinicians, business leaders, key policy makers, regulators, advocates, and experts in law & ethics from around the world.

BrainStorm (BCLI) – Bone Marrow Stem Cell Co. Profile Released

In BUSINESS OF STEM CELLS on August 27, 2009 at 8:42 am

Bone Marrow Stem Cell Company Profile Released

LAS VEGAS, Aug. 27, 2009 (GLOBE NEWSWIRE) — A report addressing one company’s research using human bone marrow stem cells has been released. The report will explore the efforts of BrainStorm (OTCBB:BCLI) and is of interest to investors of leading stem cell equities Geron (Nasdaq:GERN), Osiris Therapeutics (Nasdaq:OSIR), Aastrom Biosciences (Nasdaq:ASTM) and StemCells (Nasdaq:STEM).

From the report: BrainStorm (OTCBB:BCLI) is a leading developer of stem cell technologies to provide treatments for currently incurable neurodegenerative diseases. The Company is focused on developing NTF cells from the patient’s own bone marrow in order to treat, Parkinson, ALS, and Spinal Cord Injury.

The adult stem cells are used to create healthy NTF cells which produce and secrete neurotrophic factors, which are essential for the survival and outgrowth of neurons, and may become beneficial in neurodegenerative diseases. Patients treated with the Company’s NurOwn(tm) therapeutic cells are expected to enjoy a rapid recovery and much enhanced quality of life. BrainStorm’s therapy has the potential to cure underlying pathology, rather than simply treat symptoms. BrainStorm’s management and scientific teams are passionately devoted to the Company’s mission: regenerating the mind… in their lifetime.

via SmallCapSentinel.com: Bone Marrow Stem Cell Company Profile Released.

SSS Announces Q2/09 Fin Results

In BUSINESS OF STEM CELLS on August 27, 2009 at 8:38 am

Stem Cell Therapeutics Corp. TSX VENTURE: SSS
Aug 26, 2009 08:30 ET

Stem Cell Therapeutics Corp. Announces Second Quarter 2009 Financial Results

CALGARY, ALBERTA–(Marketwire – Aug. 26, 2009) – Stem Cell Therapeutics Corp. (“SCT”) (TSX VENTURE:SSS) today announced its financial results for the period ended June 30, 2009. Stem Cell Therapeutics Corp.

Highlights from the second quarter of 2009 and up to August 26, 2009

- May 16, 2009, SCT received a formal letter from the FDA confirming immediate removal of the clinical hold placed on the Phase IIb stroke trial, September 18, 2008. This allowed SCT to commence the recruitment of patients under an amended protocol using NTx®-265 for the Company’s Phase IIb clinical trial treating acute ischemic stroke.

- On July 20, 2009, SCT received a No Objection Letter (“NOL”) from Health Canada for the dose response designed modified REGENESIS protocol using NTx®-265 for a Phase IIb clinical trial treating acute ischemic stroke.

- On July 21, 2009, SCT received an NOL from the Drug Controller General of India (“DCGI”) to initiate the Phase IIb acute ischemic stroke trial.

- On July 27, 2009, the Company announced results from a meta-analysis of the combined BETAS Phase IIa clinical stroke trial data and REGENESIS Phase IIb clinical stroke trial data. At the time the clinical hold was placed on the REGENESIS Phase IIb trial, seven patients had been recruited, and subsequently they completed their 90-day evaluation period. Because this trial was placebo controlled, patients received either placebo or NTx®-265 and so could be combined with patient data from the non-placebo controlled BETAS Phase IIa trial where patients only received NTx®-265. By performing this type of statistical analysis, the Company was able to compare the combined data from 19 patients: 14 of which received drug (12 from BETAS Phase IIa and 2 from REGENESIS Phase IIb) and 5 patients who received placebo (all from REGENESIS Phase IIb). A decrease in the National Institute of Health Stroke Score (“NIHSS”) represents an improvement in a patient’s functionality, and importantly for a recovering patient, a decrease of 4 units in the NIHSS scale is considered a clinically relevant improvement. Of the 5 patients who received placebo, the average NIHSS actually increased by +0.7 points and out of the 14 patients who received NTx®-265, the NIHSS decreased by 8.1 points. The p-value from this meta-analysis was less than 0.0001, statistically significant.

- On August 4, 2009, the Company announced a presentation by Dr. Alan Moore, President and CEO, at the Advanced Technology Applications for Combat Casualty Care (“ATACCC”) 2009 conference which is the U.S. Department of Defense’s premier scientific meeting. Dr. Moore discussed patient recovery from brain injury by pharmacological (‘drug-induced’) activation of endogenous neural adult stem cells in traumatic brain injury (“TBI”) and stroke.

- Pursuant to an early warrant exercise incentive program that closed on August 7, 2009, warrant holders exercised 1,878,000 warrants for the same number of common shares and provided the Company with $300,480 in proceeds.

- On August 11, 2009, SCT announced enrollment of the first patient in its modified REGENESIS Phase IIb acute ischemic stroke trial. The modified REGENESIS trial is a double-blind, randomized, placebo-controlled Phase IIb clinical trial for SCT’s lead program, NTx®-265, for the treatment of acute ischemic stroke. This first patient was enrolled by the clinical team of Dr. Vijaya Pamidimukkala from the Lalitha Super Specialties Hospital Pvt Ltd in Guntur, Hyderabad, A.P.

Financial Review

The Company’s loss for the six month period ended June 30, 2009 decreased by $1,018,030 to $1,873,995 ($0.01 per common share) from the loss of $2,892,025 ($0.03 per common share) reported for the six month period ended June 30, 2008. The primary reasons for the decrease in loss were decreases in research and development costs, general and administration expenses, management and consulting fees and deemed interest charges offset by a decrease in interest income earned during the period.

Capital Position

As of June 30, 2009, the Company’s working capital (current assets minus current liabilities) was $4,241,743 ($5,803,377 as of December 31, 2008).

Outstanding securities as of August 25, 2009 are 134,680,497 common shares, 17,097,000 common share purchase warrants, and 11,002,500 common share options.

Dr. Alan Moore, President and CEO of SCT, commented as follows:

“We are excited to have commenced the modified REGENESIS Phase IIb acute ischemic stroke trial. Due to the cost cutting measures initiated by the Company in the first quarter of this year, we have managed to preserve sufficient capital to complete the modified REGENESIS Phase IIb stroke trial. We anticipate completion of the recruitment phase of the stroke trial by the end of this year and the release of the top-line data by the first quarter of 2010.”

The Company is also announcing that an aggregate of 960,000 stock options will be issued to SCT’s officers and Board of Directors on Friday August 28th based on the closing price of Thursday August 27th. These Options are being granted to those who voluntarily rolled back their salaries as part of the cost-cutting initiative announced earlier this year. These options were awarded in accordance with the Company’s Stock Option Plan.

About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp. is a Canadian public biotechnology company (TSX VENTURE:SSS) focused on the development and commercialization of drug-based therapies to treat central nervous system diseases. SCT is a leader in the development of therapies that utilize drugs to stimulate a patient’s own resident stem cells. The Company’s programs aim to repair brain and nerve function lost due to disease or injury. The Company’s extensive patent portfolio of owned and licensed intellectual property supports the potential expansion into future clinical programs in numerous neurological diseases such as traumatic brain injury, multiple sclerosis, Huntington’s disease, Alzheimer’s disease, and ALS.

GERON SAYS: PRODUCT PRODUCED CYSTS

In STEM CELLS IN THE NEWS on August 27, 2009 at 8:15 am
Geron Comments on FDA Hold on Spinal Cord Injury Trial

MENLO PARK, Calif.–(BUSINESS WIRE)–Geron Corporation (Nasdaq:GERN) today provided additional comments on the recent clinical hold on its Spinal Cord Injury IND.

As biologic therapeutics advance in clinical trials, it is common practice to optimize product characteristics, improve manufacturing efficiency and scale, and to test the product in multiple disease models. As part of these ongoing efforts at Geron with respect to GRNOPC1, various animal studies were, and continue to be, performed to characterize the product’s effects in vivo. In previous animal studies of GRNOPC1 using materials that passed release specifications, a very low frequency of injected animals developed microscopic cysts in the regenerating injury site. These cysts were non-proliferative, confined to the injury site, and had no adverse effects on the animals. No animals developed teratomas or any other ectopic structure. Cysts of much larger size appear in the spinal cord scar tissue of up to 50% of patients with spinal cord injury.

A just completed animal study showed a higher frequency of cysts, although their characteristics were similar to the cysts seen in previous studies: non-proliferative, confined to the injury site, smaller than the injury cavity and not associated with adverse clinical outcomes.

As part of our ongoing product improvement efforts, new candidate markers and assays for product release have been identified that are linked with cyst formation across all animal studies in which cysts were found. Importantly, a manufactured lot of GRNOPC1 that was assessed using these markers and assays showed no cysts in another recently concluded animal study in spinal cord injured rats.

We have submitted these data to the FDA and are in discussions with the agency to answer its questions and proceed with the clinical trial. We are committed to the optimization of all our hESC-based products as we improve the manufacturing process and identify improved product release criteria.

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