Generex Announces Expansion Plan for the U.S. FDA Expanded Access Treatment IND Program for Generex Oral-lyn(TM) in the United States.

Along With Its Strategic Relationships for the Education, Training and Dispensary Services Involved in the Treatment IND Program, Generex Oral-lyn(TM) Will Also be Introduced to Nurse Practitioners With the State Authority to Prescribe

http://www.globenewswire.com/newsroom/news.html?ref=rss&d=187593&topic=4


WORCESTER, Mass., March 29, 2010 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that it has expanded its plans for its United States Food and Drug Administration (FDA) Expanded Access Treatment IND Program for its flagship product, Generex Oral-lyn™, to include licensed and qualified Nurse Practitioners in the United States.

Nurse Practitioners in a total of 11 states within the United States have the authority to issue prescriptions to patients without medical doctor collaboration.

In September, 2009, the FDA approved the treatment use of Generex Oral-lyn™ under the FDA's Treatment Investigational New Drug (IND).

The FDA's Treatment IND program allows companies to provide early access to investigational drugs for patients with serious or life-threatening conditions for which there is no satisfactory alternative treatment. Drugs that are granted approval by the FDA for the Treatment IND program MUST demonstrate the prospect of efficacy through clinical testing.

Under the Expanded Access Treatment IND program, Generex Oral-lyn™ will be provided to patients with serious or life-threatening Type 1 or Type 2 diabetes mellitus, with no satisfactory alternative therapy available for the treatment of diabetes, and who are not eligible to participate in the Company's ongoing global Phase III pivotal clinical trial.

This Treatment IND will be open to eligible patients that comply with the inclusion/exclusion criteria of the protocol, including those who are taking currently approved anti-diabetic medications. There are no oral or injectable medications contraindicated for this IND program.

The Company continues to work with its key strategic relationships under the Treatment IND Program in the U.S. for Generex Oral-lyn™ including Assured Pharmacy, which will provide Generex Oral-lyn™ dispensary services to physicians and patients in the program. Assured Pharmacy will also undertake the enrollment of family physicians, endocrinologists, and now, nurse practitioners in the program. TS Biopharma, a multi-tiered pharmaceutical development services organization, will continue to assist in mounting a recruitment campaign for the participation in the program consisting of physicians, nurse practitioners and patients. Health Management Resources is also participating in the program recruitment activities.

"We are so pleased to have the opportunity to include nurse practitioners in the FDA's Treatment IND Program in the United States," said Anna Gluskin, the Company's President and Chief Executive Officer. "Nurse practitioners are usually at the front lines of dealing with patients with diabetes and have the skill set to work closely with patients to implement new safe and efficacious tools in the diabetes treatment paradigm."

In order to learn more about the availability of Generex Oral-lyn™ under the program, as per FDA requirements, the Company has provided information within the www.ClinicalTrials.gov website. Details include program design and participating sites and/or physicians.

Generex Pipeline
Review by R J Steffens

http://pipelinereview.blogspot.com/

March 9, 2010
Starting Treatment Early Doubles Chance of Success for People with Diabetes.



(PORTLAND, Ore.)—The sooner people with diabetes start taking metformin, the longer the drug remains effective, according to a Kaiser Permanente study published in the March issue of Diabetes Care, a journal of the American Diabetes Association.

The study found that metformin, an inexpensive, generic drug that helps patients prevent dangerously high blood sugar levels, worked nearly twice as long for people who began taking it within three months of their diabetes diagnosis. This is the first study to compare metformin failure rates in a real-world, clinical practice setting. Other studies compared failure rates of metformin only in clinical trials.

Metformin is recommended as a first-line agent in the treatment of type 2 diabetes, but in most patients it eventually stops working, forcing them to take additional medications to control their blood sugar. Each additional drug adds extra costs and the possibility of more side effects including weight gain, so this study is welcome news for newly diagnosed patients, researchers said.

“This is an important finding for the 30 million people world-wide who are diagnosed with type 2 diabetes every year. The sooner they start taking metformin, the better and longer it seems to work,” said the study’s lead author Jonathan B. Brown, PhD, an investigator with the Kaiser Permanente Center for Health Research in Portland, Ore. “This study suggests that to gain full benefit from metformin, patients should start taking it as soon as they find out they have diabetes.”

Researchers used electronic health records to follow nearly 1,800 people with diabetes in Kaiser Permanente’s health plan in Washington and Oregon for up to five years. Metformin failed at a rate of only 12 percent a year for the patients who began taking it within three months of diagnosis. That compares to a failure rate of 21.4 percent per year for patients who started taking metformin one to two years after diagnosis, and 21.9 percent per year for those who didn’t start taking the drug until three years after they were diagnosed.

“We believe that starting the drug early preserves the body’s own ability to control blood sugar, which in turn prevents the long-term complications of diabetes like heart disease, kidney failure, and blindness,” said study co-author Gregory A. Nichols, PhD, an investigator with the Kaiser Permanente Center for Health Research. “The American Diabetes Association recommends that patients start taking metformin and make lifestyle changes as soon as they are diagnosed. This study provides more evidence to back up that recommendation.”

In the study, patients were considered to have failed metformin when their hemoglobin A1C—a test that monitors glucose control---went above 7.5 percent or when they started taking a second anti-hyperglycemic agent. Only patients who initially controlled blood sugar (to less than 7 percent on the A1C test) with metformin were included in the study.

To reduce the possibility that factors other than delay in starting metformin influenced the results of the study, researchers controlled for age, gender, and how well blood sugar was controlled prior to treatment. After controlling for these factors, an even stronger relationship emerged between the time a patient started on the drug, and the amount of time it remained effective. Still, the authors caution that other unmeasured factors could have influenced the results.

The study was funded by Novo Nordisk, Inc., a company that does not make or sell metformin and has no financial interest in, or connection to, Kaiser Permanente.

Study authors include: Jonathan B. Brown, PhD, MPP, and Gregory A. Nichols, PhD, from the Kaiser Permanente Center for Health Research in Portland, Ore., and Christopher Conner, PharmD, PhD, from Novo Nordisk, Inc., Seattle.





Generex files application for oral/buccal metformin patent.
http://www.thefreelibrary.com/Generex+files+application+for+oral%2Fbuccal+metformin+patent-a0132417055

Dow & Nas are green!

GNBT (again) red and the support is broken!
$0.58
503 K

Wed, Feb 10 2010.
Economy and Politics.
Probe on as oral insulin shows up on shelves.

Eleven months after marketing approval was suspended, Oral Recosulin turns up on Delhi pharmacy shelves.
http://www.livemint.com/2010/02/10000457/Probe-on-as-oral-insulin-shows.html


New Delhi: The Central Drugs Standard Control Organisation has launched an investigation into how a suspended anti-diabetic oral insulin drug has been on sale in the Capital, prompted by Mint’s findings.

It is now in the process of “freezing” Oral Recosulin at all retail pharmacies. This means that the pharmacy cannot dispose or sell the stock till further orders from the regulator. The drug is marketed in India by Mumbai-based Shreya Life Sciences Pvt. Ltd.

India’s drugs regulator had halted marketing approval and the import licence for Oral Recosulin in March 2009 following a Mint report in March that revealed the drug, manufactured by Canada-based Generex Biotechnology Corp., had been approved for sales in India without local human clinical trials, as mandated by The Drug and Cosmetics Act.

On Monday, 11 months after its sale was suspended by the Drug Controller General of India (DCGI), Mint was able to purchase Oral Recosulin from a local pharmacy in Delhi for Rs2,389.

The batch number of the drug, which has an import date of 25 April 2008 and expires in July 2010, is 8ER0702. Mint informed DCGI of this.

Calls and emails to both Shreya and Generex remained unanswered at press time. However, a Shreya executive told Mint on condition of anonymity that DCGI had “categorically told us that not a single vial of the drug should be available in the market. DCGI granted us permission to conduct phase III human clinical trials, which we are doing already.”

In August 2009, Mint had reported that DCGI had asked Shreya to conduct the mandatory phase III trials. The trials were needed before marketing approval because under Indian law, it falls under the category of a “new drug” because it is administered by inhalation as opposed to the widely used method of injection. At the time it got marketing approval in India in late 2007, Oral Recosulin (known as Oral-Lyn in other countries), was being sold only in one other country —Ecuador.

“Generex has been in talks with the health ministry for revoking the marketing suspension, but we wrote to them 10 days ago that their Indian agent Shreya Life Sciences has applied for a clinical trial, so how can they ask for an approval before that is complete?” said DCGI Surinder Singh. “We will investigate this matter and find out how this drug is still being sold.”

A December 2009 Generex press release referred to the drug being on sale in the country. “The company’s flagship product, oral insulin (Generex Oral-lyn(TM)), which is available for sale in India, Lebanon, Algeria, and Ecuador for the treatment of subjects with Type 1 and Type 2 diabetes, is in phase III clinical trials at several sites around the world,” it said.

Mint found that other pharmacies too had stocks of the drug readily available for sale.

“We had got 16 packs of the product though none of them have been sold. However, even in this period we have not received any communication from the company to either recall the drug or stop its sale,” said Jai Kumar, who looks after the Apollo Pharmacy chain in Delhi. The stock available with them bears the same batch number as the product purchased by Mint.

Prior to the suspension of its import licence, Generex had obtained marketing and import permission for 10 million packs of the drug.

In April, Ram Shelat, director (domestic business) at Shreya Life Sciences had said in an email response to Mint that “based on DCGI’s letter, we have stopped sales and dispatches of the product. We have not placed any further order to Generex for import.”

Unfortunate, but we went slowly down?!
$0.5852
435 K

Too easily break $0.60

$0.589
819 K

<<< I guess some people panic and act first; hence the selling of some shares at .55 in AHs. In addition, I'm sure the MM does what he can by dropping prices and other things to make people think they should sell. >>>

But AH 140 K, are rather a lot of shares!


>>> So, I'm very positive about this company. <<<

Me too.

As filed with the Securities and Exchange Commission on
January 29, 2010

http://www.pinksheets.com/edgar/GetFilingHtml?FilingID=7013939



AH
$0.59
144 K
http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx?selected=GNBT&mkttype=after&symbol=LMRA&symbol=LDK&symbol=SFLK&symbol=FLRP&symbol=GNBT

CRAVE-nx
http://www.crave-nx.com/


Sold Out
http://well.ca/products/crave-nx_14375.html

Business News

Top Healthcare Stocks are INCY, SIGA, GNBT
Healthcare Stocks.

Dallas,
TX 1/06/2010 05:46 GMT (TransWorldNews)
http://www.transworldnews.com/NewsStory.aspx?id=154598&cat=1




Generex Biotechnology Corporation (NASDAQ:GNBT) surged 3.58% to $0.575 with a massive volume of 1.04 million shares. Generex Biotechnology Corporation (Generex) is a development-stage company. The Company is engaged in the research, development and commercialization of drug delivery systems and technologies. The Company is focused on its technology for the administration of formulations of large molecule drugs to the oral (buccal) cavity using a hand-held aerosol applicator.

Or -50% after the R/S!





Comparison of recombinant and plasma-derived antithrombin biodistribution in a rabbit model.
Berry LR, Thong B, Chan AK.
Henderson Research Centre, Hamilton, Ontario L8V 1C3, Canada. lberry@thrombosis.hhscr.org
http://www.ncbi.nlm.nih.gov/pubmed/19652880?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum


Antithrombin (AT) is a native plasma protein that acts as the main inhibitor of enzymes generated by the coagulation cascade. In extreme thrombotic conditions, consumption of plasma AT can make treatment with AT-associated heparin therapies less effective. Supplementation with recombinant human AT (rhAT) has shown promise but altered pharmacokinetics were observed when comparing stable heparin complexes of the plasma-derived AT (pAT) and rhAT proteins. To understand the differential clearance mechanisms, biodistribution of rhAT and pAT was determined. (125)I-labelled ATryn (rhAT) or Kybernin P (pAT) was intravenously injected into rabbits. At various time points, animals were sacrificed and organs analysed for bound radioactivity. (131)I-albumin, injected shortly before termination, was used as a marker for trapped blood. Levels of circulating protein + metabolites were significantly less for rhAT than pAT (p < 0.001) and removal of acid soluble fragments confirmed that differences were due to more rapid rhAT clearance. More rhAT (28% dose) than pAT (3% dose) was liver-associated by the earliest time points, corresponding to elevated rhAT degradation products in urine/feces. However, at intermediate times (4 hours), rhAT showed significantly increased arterial and venous uptake over pAT (p </= 0.001). These vessel wall interactions accounted for the primary differences between clearance of rhAT and pAT during these time periods. Overall, circulating rhAT is more rapidly lost to the liver and vessels than pAT. Increased vessel wall binding may facilitate rhAT treatment of vascular thrombosis.

Journal of Clinical Oncology, 2009 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 27, No 15S (May 20 Supplement), 2009: 3011
© 2009 American Society of Clinical Oncology
This Article

http://meeting.ascopubs.org/cgi/content/abstract/27/15S/3011


Results from the first phase I clinical study of the novel Ii-Key/HER2/neu(776–790) hybrid peptide vaccine in patients with prostate cancer
S. A. Perez, S. Bisias, N. L. Kallinteris, A. Ardavanis, K. G. Georgakopoulou, N. Apostolikas, A. Thanos, M. Papamichail, E. von Hofe and C. N. Baxevanis
Saint Savas Cancer Hospital, Athens, Greece; Antigen Express, Inc., Worcester, MA


Background: HER-2/neu(776–790) represents an immunogenic epitope from the HER-2/neu oncoprotein whose immunogenicity is highly potentiated upon linkage with the Ii-Key moiety (LRMK) from the MHC class II invariant chain. Herein, we present the results of the first phase I clinical trial of the Ii-Key/HER-2/neu(776–790) (AE37) vaccine in patients (pts) with prostate cancer.

Methods: Androgen-dependent (AD) and androgen-independent (AI) pts with HER-2/neu+ (IHC: 1–3) prostate adenocarcinomas were eligible. Concomitant medication with bicatulamide and LHRH or docitaxel was allowed. All pts received 6 monthly vaccinations with the AE37 vaccine (500 µg of AE37 plus 125 µg of GM-CSF) administered in two doses intradermally 5cm apart in the same extremity for each vaccination cycle. Immunologic responses were measured monthly in vitro by the IFN-based ELISPOT assay using pts’ PBMC and in vivo at the beginning and end of immunizations using DTH. Local dermal reactions were also measured after each vaccination.

Results: Eligible pts [AD (n=18), AI (n=10)] were at stages T1–3N0M0, GS: 3–7 (n=18); T1–3N+M0, GS: 6–7 (n=2); T1–3N0M+, GS: 6–9 (n=4) and T1–3N+M+, GS: 6–9 (n=4). All pts had standard treatment prior to vaccinations, including surgery (S) (n=9); hormonal treatment (HT) (n=4); S+HT (n=6); S+HT+radiotherapy (RT); (n=2); S+chemotherapy (CH) (n=2); HT+RT (n=2); CH (n=3) and S+HT+CH (n=2). During vaccinations, 11 pts were free of any treatment, while 5 pts who had progressive disease received additional chemotherapy; the remainder received HT alone or combined with RT. 25 pts completed all vaccinations. Toxicity and side effects beyond grade-2 were not observed. GM-CSF was reduced by 50% for subsequent vaccinations when a local reaction of 100mm or greater was observed. DTH reactions to the parent HER-2/neu(776–790) peptide were increased (compared to pre-vaccination) for all pts, while approximately half the pts responded with significantly increased IFN responses to AE37 and/or parent HER-2/neu(776–790) peptide in at least 2 sequential vaccination cycles.

Conclusions: <<<<<The AE37 vaccine is safe and well tolerated. AE37 is also capable of eliciting potent and specific immunologic responses in prostate cancer pts.>>>>>

Vaccine Therapy in Treating Patients With Breast Cancer

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), June 2009
First Received: August 31, 2007

Last Updated: June 16, 2009

http://clinicaltrials.gov/ct2/show/NCT00524277?term=AE37&rank=1


AE37 is a blockbuster

<<What's the connection?>>

I don't think you know GNBT?



Here have you two examples:
http://www.generex.com/press_release_desc.php?id=87&year=

BC Vaccine
http://www.generex.com/technology.php



<<How long does it take to finish Phase II?>>
http://clinicaltrials.gov/ct2/show/NCT00524277?term=AE37&rank=1

Nobody?

Vaccine Therapy in Treating Patients With Breast Cancer
AE37
Study Start Date:
January 2007
http://clinicaltrials.gov/ct2/show/NCT00524277?term=AE37&rank=1


How long does it take to finish Phase II?

Very important, this is a great blockbuster.

First Time in Human Study of Protexia

Estimated Study Completion Date: March 2009
http://clinicaltrials.gov/ct2/show/NCT00744146?term=Protexia&rank=1

Anyone?

Pipeline 2008

Launch ATryn® was 2008
http://www.leo-pharma.com/41256A84002BE7FC/(AllDocsByDocId)/2691A92F74995CB1C1256BA00050866D?OpenDocument

Was it 01.01.2008 or 12.31.2008??
There are always so quiet about the launch EU?

BAC to develop Factor VIIa purification ligand for LFB
http://www.in-pharmatechnologist.com/Processing-QC/BAC-to-develop-Factor-VIIa-purification-ligand-for-LFB

GTC BIOTHERAPEUTICS AND LFB BIOTECHNOLOGIES ENTER STRATEGIC COLLABORATION FOR RECOMBINANT PLASMA PROTEINS AND MONOCLONAL ANTIBODIES
http://www.gtc-bio.com/pressreleases/pr100206.html
http://www.lfb.fr/upload/Page/Fichier2/202.pdf

LFB BIOTECHNOLOGIES AND GTC BIOTHERAPEUTICS TO COLLABORATE ON rhAAT PROGRAM
http://www.lfb.fr/Client/EN/page.aspx?Methode=ClientFDetail&IDBase=578&Composant=Information&ref=group

Expert Opin Biol Ther.
2009 Jan

CD4+ T cells in antitumor immunity: utility of an li-key HER2/neu hybrid peptide vaccine (AE37).
Mittendorf EA, Holmes JP, Murray JL, von Hofe E, Peoples GE.
University of Texas MD Anderson Cancer Center, Department of Surgical Oncology, Houston, TX 77030, USA. eamitten@mdanderson.org
http://www.ncbi.nlm.nih.gov/pubmed/19063694?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum


BACKGROUND: Early clinical trials of HER2/neu-derived peptide vaccines indicate that they may be useful for preventing recurrence in breast cancer patients rendered disease-free after standard-of-care therapy. An effective vaccination strategy will probably require stimulation of T helper (Th) cells. AE37 is an HER2/neu-derived peptide that has been modified to enhance antigen-specific stimulation of Th cells by linkage of the Ii-Key moiety of the MHC class II-associated invariant chain (Ii protein).
OBJECTIVE: To review the literature regarding the role of a Th response in immunotherapy with a focus on this novel HER2/neu-derived AE37 peptide.
RESULTS/CONCLUSION: Improved immuno-genicity of the AE37 Ii-key hybrid peptide has been demonstrated in animal models, ex vivo patient cells, and, most recently, in a Phase I clinical trial in breast cancer patients. Future clinical trials incorporating AE37 into a peptide vaccine strategy are warranted.

PMID: 19063694 [PubMed - indexed for MEDLINE

Reversal of coagulopathy in critically ill patients with traumatic brain injury: recombinant factor VIIa is more cost-effective than plasma.
http://www.ncbi.nlm.nih.gov/pubmed/19131807?dopt=Abstract

Stein DM, Dutton RP, Kramer ME, Scalea TM.
J Trauma. 2009 Jan.

R. Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, Maryland 21201, USA. dstein@umm.edu

BACKGROUND: Traumatic brain injury (TBI) is the leading cause of death and disability after trauma. Coagulopathy is common in this patient population and requires rapid reversal to allow for safe neurosurgical intervention and prevent worsening of the primary injury. Typically reversal of coagulopathy is accomplished with the use of plasma. Recombinant factor VIIa (rFVIIa; NovoSeven, Novo Nordisk, Bagsvaerd, Denmark) has become increasingly used "off-label" in patients with neurosurgical emergencies to rapidly reverse coagulopathy. We hypothesized that the use of rFVIIa in this patient population would prove to be cost-effective as well as demonstrate clinical benefit.
METHODS: The trauma registry at the R Adams Cowley Shock Trauma Center was used to identify all coagulopatic trauma patients admitted between January 2002 and December 2007 with relatively isolated TBI (head Abbreviated Injury Scale score of >or=4). The medical records of patients were reviewed and demographics, injury-specific data, medications administered, laboratory values, blood product utilization, neurosurgical procedures, length of stay (LOS), discharge disposition, and outcome data were abstracted. Patients who received rFVIIa for reversal of coagulopathy were compared against those who did not receive rFVIIa. t Tests were used to compare differences between continuous variables, and chi2 analysis was used to compare categorical variables. A p value of <0.05 was considered significant for all statistical tests.
RESULTS: During a 6-year period, there were 179 patients who met inclusion criteria. One hundred eleven patients (62.0%) were treated with conventional therapy alone whereas 68 (38.0%) received rFVIIa. Baseline characteristics between the two groups were similar except that Injury Severity Score and admission International normalized ratio were higher in the rFVIIa group and the rFVIIa group had a higher percentage of patients with head Abbreviated Injury Scale score of 5 injuries, patients who underwent neurosurgical procedures and patients with preinjury warfarin use. There was no difference in total charges between these groups (mean US $63,403 in the conventionally treated group vs. $66,086). When patients who required admission to the intensive care unit were analyzed (n = 110, 50% received rFVIIa), total mean charges and costs were significantly lower in the group that received rFVIIa (mean US $108,900 vs. $77,907). Hospital LOS, days of mechanical ventilation, and plasma utilization were lower in the rFVIIa group. Mortality and thromboembolic complication rates were not different between the two groups.
CONCLUSION: In this study, we were able to demonstrate a significant economic benefit of the use of rFVIIa for reversal of coagulopathy in severely injured patients with TBI. Not all patients with coagulopathy and an anatomic brain injury benefit, but in patients who are neurologically or physiologically compromised, using rFVIIa decreases total charges and costs of hospitalization. This decrease in overall cost is directly attributable to the significant decrease in LOS and decrease in the need for mechanical ventilation. This study demonstrates that in coagulopathic patients with TBI who require intensive care unit admission, rFVIIa is cost-effective and safe. Prospective studies are needed to confirm these findings and establish clinical effectiveness.

Publication Types:
Research Support, Non-U.S. Gov't

PMID: 19131807 [PubMed - in process]






Use of albumin fusion technology to prolong the half-life of recombinant factor VIIa.
http://www.ncbi.nlm.nih.gov/pubmed/18929521?dopt=Abstract

Schulte S.
Thromb Res. 2008

CSL Behring GmbH, Emil-von-Behring Strasse 76, Marburg, Germany. Stefan.schulte@cslbehring.com

A significant proportion of patients with haemophilia A develop inhibitors to administered factor VIII (FVIII) and require therapy with bypassing agents such as activated factor VII (FVIIa) or activated prothrombin complex concentrates. NovoSeven is a commercially available recombinant FVIIa (rFVIIa) with a very short half-life of approximately 2.4 hours. As a result, patients generally require multiple, frequent infusions for the management of bleeding episodes. Thus, there is growing interest in extending the circulating half-life of coagulation factors through the use of innovative drug delivery and formulation technologies. One such approach uses albumin fusion technology in which human albumin is genetically fused to the C-terminus of rFVIIa via a flexible glycine serine linker. The properties of this rFVIIa fusion protein (rVIIa-FP) have recently been examined in pre-clinical studies. Results from these investigations demonstrate the feasibility of this approach, which successfully extended the half-life and biological activity of rFVIIa without compromising haemostatic efficacy. These data suggest that rVIIa-FP may be a promising therapy for the treatment of haemophilia patients with inhibitors and warrants further investigation in clinical trials.

Publication Types:
Research Support, Non-U.S. Gov't
Review

PMID: 18929521 [PubMed - indexed for MEDLINE]

OK

Thx

BLOOD PRODUCTS ADVISORY COMMITTEE
93rd Meeting –
January 9, 2009
Hilton Hotel, 1750 Rockville Pike, Rockville, MD
http://www.fda.gov/ohrms/dockets/ac/09/agenda/2009-4410A(draft).htm

http://www.fda.gov/ohrms/dockets/ac/09/briefing/2009-4410B1-00-Index.html




One week later!

CSL Behring Receives FDA Approval of RiaSTAP(TM), First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency
http://www.fda.gov/bbs/topics/NEWS/2009/NEW01948.html



Can ATryn® be the next, later this week?

02.07.2009

The Land of Milk and Money
The first drug from a transgenic animal may be nearing approval
By Gary Stix

January 15,
2009 in Health
http://www.sciam.com/article.cfm?id=atryn-the-land-of-milk-and-mone

FDA to adopt more transparent process for GE animals
Thu Jan 15, 2009 2:19pm

By Christopher Doering
http://www.reuters.com/article/scienceNews/idUSTRE50E6VQ20090115

WASHINGTON (Reuters) - The Food and Drug Administration said on Thursday it would make the process it uses to approve genetically engineered animals more transparent, but consumer groups expressed concern the government was not going far enough to protect the pubic.

The guidelines being finalized by the FDA bring the decades-old technology of genetic engineering for animals one step closer to the dinner table. Officials from the FDA would not speculate when the first of the applications, which are in various stages of development, would be approved.

"We recognize that many people have strong views on these subjects," said FDA Deputy Commissioner Randall Lutter.

He vowed the FDA guidelines would provide a "rigorous and predictable science-based framework" to review genetically engineered animals in a timely and transparent manner.

Genetically modified cattle, pigs, fish and goats are being produced for a variety of uses. Some produce pharmaceuticals in their milk or blood. Others are resistant to diseases, such as mad cow, or produce more healthful meat or milk.

FDA said its framework would help producers know what the government will need to determine safety and verify that the genetically engineered trait is doing what it claims.

A draft document outlining the process, first issued in September and later opened to public comment, was criticized by some groups as being secretive and lacking transparency.

In response to more than 28,000 comments from consumers, food and pharmaceutical companies, and others, FDA said it would now hold a public advisory committee meeting before making a decision on an application.

"FDA has made some small but important changes to increase the transparency of the regulatory process, but it really depends on how they implement the new practice," said Gregory Jaffe of the Center for Science in the Public Interest.

He said key questions included what information FDA will release, when will it be released and how the public can participate in the process.

The FDA also said it would make public when it intends to exempt a producer from having to submit an application. Certain animals being used for research and not being consumed as food, such as rats or mice, would qualify.

The framework being finalized by FDA requires producers of genetically engineered animals to describe what DNA they have inserted into the animal, how it behaves in the animal, the impact on the animal's health, and show the product is not different from traditional food.

Labeling would be required only if there is a significant change in the food, such as if pork from pigs is engineered to produce meat with higher levels of omega-3 fatty acids.

"We think it's outrageous that they're not going to require labeling," said Michael Hansen, a senior scientist with Consumers Union. "So many consumers want this."

The FDA said it has the authority to regulate genetically engineered animals through the Federal Food, Drug and Cosmetic Act. The measure identifies a drug as anything that changes the "structure or any function" of a person or animal.

(Editing by Walter Bagley)

New old-fashioned drug makers: Goats

Los Angeles Times
http://www.latimes.com/news/nationworld/nation/la-sci-geneticmilk10-2009jan10,0,242781.story

Chicago Tribune
http://www.chicagotribune.com/news/nationworld/la-sci-geneticmilk10-2009jan10,0,2082362.story

Buyout Binge Begins for Bio-Pharma, Diagnostics
By: Mike Havrilla Saturday, January 10, 2009 2:14 PM
http://www.istockanalyst.com/article/viewarticle/articleid/2942694

With news late Friday that Roche (RHHBY) is prepared to up its bid for complete control of Genentech (DNA) to $95 from a previous offer of $89 per share and a $41M ($1.50 per share) all-stock takeover offer by Sequenom (SQNM) for EXACT Sciences (EXAS); 2009 is off to a strong start for M&A activity in the bio-pharma and diagnostic space.


Larger and well funded bio-pharma and diagnostic companies are opportunistically looking to expand their product offerings, pipeline prospects, patent portfolios, and drug discovery technology platforms with the huge declines in the stock prices for the 250 companies included in the following ETF Innovators Indexes:

Emerging Diagnostic Index: Average loss of 63.2%, including 39 companies with average market cap of $50M

Emerging Bio-Pharma Index: Top 40 Rated Companies

Emerging Bio-Pharma Index: 36 Additional Companies

Micro-Cap Bio-Pharma Index: Click to enlarge accompanying table of 130 companies with an average loss of 43.6% in past year and average market cap of $58M

Some examples of buyouts in these indexes include:

1.) EXAS is up over 140% in the past month and the $41M takeover offer by SQNM represents a 50% premium from the closing price of 99 cents on Friday

2.) SGX Pharma was acquired for $64M cash by Eli Lilly (LLY) for its cancer drug discovery platform

3.) Kosan Biosciences was acquired by Bristol-Myers (BMY) for its cancer drug pipeline

4.) Pfizer's (PFE) $164M cash buyout of cancer drug developer Coley Pharma

5.) GlaxoSmithKline's (GSK) $57M buyout of Genelabs (GNLB) at a 400%-plus premium.

Over the past year, the declines in the indexes outlined above were more severe than the overall market and benchmark healthcare ETFs comprised of larger companies, such as iShares Nasdaq Biotech (IBB), PowerShares Dynamic Pharma (PJP), the Healthcare Sector SPDR (XLV), and SPDR S&P Biotech (XBI).

Many of the companies in the accompanying table also have pending FDA decisions which will likely have major impacts on the stock prices, including Labopharm (DDSS), BioDelivery Sciences (BDSI), Advanced Life Sciences (ADLS), Discovery Labs (DSCO), GTC Biotherapeutics (GTCB), and Northfield Labs (NFLD).

The common theme for the buyouts listed above includes spending a very small amount of money or issuing stock to acquire patents, pipeline compounds, marketed products, or technology platforms which are trading at distressed prices – with three of the five deals focused on cancer drug development while EXAS is being acquired for its patent portfolio focused on prenatal + cancer diagnostics just one day after announcing that its stool-based DNA screening test was added to the colorectal cancer screening options in 12 more states + Washington DC.

Animals for drugs
January 10, 2009 by Richard
http://pathtosustainable.wordpress.com/2009/01/10/animals-for-drugs/

ROCKVILLE, Maryland (Reuters) - The first drug made using genetically engineered animals to near U.S. approval won key support on Friday from an advisory panel that judged it safe and effective despite concerns from groups worried about the genetic tinkering.

GTC Biotherapeutics Inc’s experimental anticlotting therapy, called Atryn, is made using a human protein gathered from female goats bred to produce it in their milk.

Producing therapeutic drugs in animals rather than in human cell culture or bacteria could have substantial effects on the costs associated with many drugs. The physical plants needed to produce many protein-based drugs are extremely costly. Actual capacity is limited and can take years to build.

In addition, there are difficulties with the cost of manufacture itself (i.e. the specialized media needed to grow the cells) as well as waste disposal problems after the protein has been produced.

Pharming overcome these difficulties with a more sustainable approach. Not only are media costs much less (i.e. potentially actual chicken feed) but the production levels (that is, the amount of protein per volume of ‘media’) can be much greater. This means a herd of 150 goats could produce the world’s supply of a drug, rather than a $100 million manufacturing facility.

Using farm animals hold advantages over using plants. Plant fertilization can be problematic, since pollen is air-borne. It is much easier to monitor the whereabouts of animals than of plants, so it is unlikely that the GM animals will trade genes with other animals. Production animals can be neutered so that no genes will be passed in any unintended fashion. Disposal could proceed much like current drug facilities but the ‘waste’ should be much smaller. Energy costs would be less.

Animals from rabbits to cows can be used. The economic footprint of this approach appears to be much lower than the huge footprint of a 10,000 liter manufacturing plant. In addition, scaleup would be much easier and more quickly performed using animals.

Often new products render a current therapeutic obsolete. Currently, the expensive manufacturing facility must then be modified for a new product or sold to someone who needs the capacity. Mothballing a facility can be very expensive and modifying it can also entail a large cost, which is passed onto us. Not so with animals.

A big plus is that instead of only producing drugs with a billion dollar market, the economies of this approach could make it easier to produce drugs for much smaller markets. Thus a more sustainable approach for the production of therapeutics could be maintained.



Technorati Tags: Environment, Science, Sustainability

Gtc Biotherapeutics Inc (NASDAQ:GTCB)

http://www.mffais.com/gtcb.html

Phase 2 Study of MM-093 to Treat Patients With Uveitis
This study has been completed.

http://clinicaltrials.gov/ct2/show/NCT00444743?term=MM-093&rank=1&flds=Xabcm
Last Updated
December 16, 2008

Vaccine Therapy in Treating Patients With Breast Cancer

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008

Last Updated
December 6, 2008
http://clinicaltrials.gov/ct2/show/NCT00524277?term=AE37&rank=1

What about the launch ATryn® in the UK?
Nothing hear since june 2006?

$0.12 bahhh

13 cent to go, and it's over!!!

What a f.... share is this??

GTC Biotherapeutics Inc Is Working With LFB Biotechnologies to Develop Recombinant Forms of Human Factor VIIa and A CD20 Monoclonal Antibody

Last update: 11/6/2008 9:44:01 AM
http://www.tradingmarkets.com/.site/news/Stock%20News/2001105/

DUBLIN, Ireland, Nov 06, 2008 (BUSINESS WIRE) -- Research and Markets () has announced the addition of the "GTC Biotherapeutics Inc: Premium Company Profile" company profile to their offering.

GTC Biotherapeutics is engaged in the development, production and commercialization of therapeutic proteins expressed and purified from the milk of transgenic animals such as goats and cattle. ATryn, the companys major product, is a recombinant human antithrombin produced in the milk of transgenic goats.

Scope of this title - Contains corporate strategy, value chain presence and SWOT Analysis - Provides detailed business description, segment analysis, 5-year financial trends, key products and key competitors - Includes information on suppliers/ partners, shareholding structure and key employees with biographies Highlights of this title GTC develops, produces, and commercializes therapeutic proteins through transgenic animal technology.

In addition to ATryn, GTC is working with LFB Biotechnologies to develop recombinant forms of human factor VIIa and a CD20 monoclonal antibody. Total revenues of the company witnessed decline at a CAGR of 11% during 2002-2006, from $10 million to $6 million.

It derives its revenues from collaborative agreements which include non-refundable license fees, funding of research and development, payments based upon the achievement of certain milestones and royalties.

Between 2006 and 2010, the company's revenues are forecasted to increase at a CAGR of 22% from $6 million to $13 million. There will be an absolute growth of +$7 million in the company's total revenues by 2010. The company is expected to receive all of its revenues through collaborative agreements with its partners.

First Time in Human Study of Protexia
This study is currently recruiting participants.

Verified by PharmAthene, Inc., October 2008
http://clinicaltrials.gov/ct2/show/NCT00744146?term=Protexia&rank=1
Phase I

First Time in Human Study of Protexia

This study is not yet open for participant recruitment.
Verified by PharmAthene, Inc., August 2008
http://clinicaltrials.gov/ct2/show/NCT00744146?term=rBChE&rank=1






PharmAthene to Present Data for Protexia and Valortim at HHS PHEMCE Stakeholders Workshop 2008
September 19th, 2008
http://google-sina.com/2008/09/19/pharmalive-pharmathene-to-present-data-for-protexia-and-valortim-at-hhs-phemce-stakeholders-workshop-2008/

Safety, Tolerability and Immunogenicity of Recombinant Anthrax Vaccine Compared With Anthrax Vaccine Adsorbed
http://clinicaltrials.gov/ct2/show/NCT00170469?term=Anthrax&rank=2&flds=Xabco

PharmAthene UK Limited
This study has been completed.
Phase II


Last Updated
September 12, 2008





PharmAthene Response to DHHS Request for Proposals for Recombinant Protective Antigen Anthrax Vaccine Deemed Technically Acceptable and Within Competitive Range for Procurement Consideration
http://www.genengnews.com/news/bnitem.aspx?name=41875418

CD137 Induces Proliferation of Murine Hematopoietic Progenitor Cells and Differentiation to Macrophages.Jiang D, Chen Y, Schwarz H.
Department of Physiology, and Immunology Programme, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
http://www.ncbi.nlm.nih.gov/pubmed/18768847?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum

CD137 is a member of the TNFR family, and reverse signaling through the CD137 ligand, which is expressed as a cell surface transmembrane protein, costimulates or activates APCs. CD137 and CD137 ligand are expressed on small subsets of bone marrow cells. Activation of bone marrow cells through CD137 ligand induces proliferation, colony formation and an increase in cell numbers. Compared with total bone marrow cells, the small subpopulation of progenitor cells that express no lineage markers but express CD117 cells (or Lin(-), CD117(+) cells) responds with the same activities to CD137 ligand signaling, but at a significantly enhanced rate. Concomitantly to proliferation, the cells differentiate to CFU granulocyte-macrophage and CFU macrophage, and then to monocytes and macrophages but not to granulocytes or dendritic cells. Hematopoietic progenitor cells differentiated in the presence of CD137 protein display enhanced phagocytic activity, secrete high levels of IL-10 but little IL-12 in response to LPS, and are incapable of stimulating T cell proliferation. These data demonstrate that reverse CD137 ligand signaling takes place in hematopoietic progenitor cells, in which it induces proliferation, an increase in cell numbers, colony formation, and differentiation toward monocytes and macrophages.

-- Company to file Investigational New Drug (IND) Application with the United States Food and Drug Administration (FDA) for Protexia(R) and plans to initiate Phase I clinical trial in September 2008

http://www.pharmacychoice.com/news/article.cfm?Article_ID=87051