Inform Genomics Announces Results of Study Predicting Risk of Oral Mucositis in Patients Undergoing High Dose …

BOSTON--(BUSINESS WIRE)--

Inform Genomics, Inc., a private company focused on developing novel platforms of personalized medicine products for cancer supportive care and inflammatory diseases, today announced the completion of the first phase of product development to predict a patients risk of developing oral mucositis after receiving high dose chemotherapy prior to hematopoietic stem cell transplant. The results of this single center, 153-patient study demonstrated the products ability to discriminate which patients develop oral mucositis with 99.3% accuracy and an area under the Receiver Operator Characteristic (ROC) curve of 99.7%. Further development will include validation of these initial results in a multicenter study. In addition, Inform Genomics announced that it entered into a collaboration agreement with Swedish Orphan Biovitrum AB (Sobi) to further develop and commercialize the product. Sobi is a leading integrated biopharmaceutical company dedicated to bringing innovative therapies and services to improve the health of rare disease patients and their families.

We are very pleased with the exciting results of this study, said Ed Rubenstein, M.D., President & CEO of Inform Genomics, and our agreement with Sobi demonstrates the value our technology can bring to biopharma partners while expanding the market opportunity for both companies products. When commercialized, this product will be available for the hematology oncology stem cell transplant market and will complement the target market of our lead product, OnPART for patients with solid tumors.

The principal investigator for the study, Stephen T. Sonis, D.M.D., D.M.Sc., Chief Scientific Officer of Biomodels, LLC, who also serves as the Chief of the Division of Oral Medicine at the Dana-Farber Cancer Institute and Professor of Oral Medicine at the Harvard School of Dental Medicine, will present the results of the study at the upcoming 2012 American Society of Clinical Oncology (ASCO) Annual Meeting, as part of the educational session titled Mucosal Injury in Patients with Cancer: Targeting the Biology, taking place from 11:30 am to 12:45 pm on Sunday, June 3, 2012 in Chicago, IL.

About OnPART

OnPART, Oncology Preferences And Risk of Toxicity, will be Inform Genomics first platform molecular diagnostic test for personalizing treatment decisions for patients undergoing chemotherapy for colorectal, breast, lung or ovarian cancer. Based upon response rates and survival, more than one chemotherapy regimen may be considered appropriate care for patients with these common solid tumors, yet the regimens vary widely in their toxicity profiles, including nausea & vomiting, diarrhea, oral mucositis, cognitive dysfunction, fatigue and peripheral neuropathy. OnPART is being developed to assess genomic risk for these side effects, and to provide valuable information for patients and medical oncologists to help clarify clinical choices.

About Inform Genomics

Inform Genomics, Inc. is a private company focused on developing novel platforms of personalized medicine products for cancer supportive care and inflammatory diseases, including its lead product, OnPART, designed to predict an individuals risk of six common toxicities of commonly used chemotherapy regimens based on his or her individual genomic profile. The Companys business model leverages existing technology in conjunction with proprietary analytic methods for conducting genome-wide association studies. Product development programs will lead to commercial, single source laboratory tests consisting of single-nucleotide polymorphism (SNP) clusters that determine the likelihood of individual patient clinical outcomes to drug therapies. The U.S. market opportunity for these differentiated products exceeds $2 billion annually. Inform Genomics is headquartered in Boston, Massachusetts. For more information, please visit http://www.informgenomics.com.

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Inform Genomics Announces Results of Study Predicting Risk of Oral Mucositis in Patients Undergoing High Dose ...

Cryo-Cell Reports Financial Results for First Quarter 2012

OLDSMAR, Fla., April 16, 2012 /PRNewswire/ --Cryo-Cell International, Inc. (OTC:QB Markets Group Symbol: CCEL) (the "Company"), the world's first private cord blood bank to separate and store stem cells in 1992, today announced results for the first quarter ended February 29, 2012.

"Cryo-Cell's first quarter 2012 results are indicative of the many changes that are taking place at the Company," stated David Portnoy, Cryo-Cell's Chairman and Co-CEO. "In particular, the decrease in revenues is primarily a reflection of our increased pricing without the commensurate return from our new branding strategy and national sales force."

Mark Portnoy, Cryo-Cell's Co-CEO, added, "Although we were aware that the timing of the rise in expenses would not correlate directly with the timing of the rise in revenues, given the Company's unique stem cell storage services, large recurring revenue stream and strong cash position, this ongoing investment in the Company's future is the correct strategy at this time. Since Cryo-Cell was the first company in the world to separate and store stem cells in 1992, the new branding and sales initiatives will help maintain our leadership in the field."

Financial Results

Consolidated revenues for the first quarter of fiscal 2012 were approximately $4.2 million compared to approximately $4.5 million for the first quarter of fiscal 2011. The revenues for the first quarter of fiscal 2012 consisted of approximately $3.8 million in processing and storage fee revenue and approximately $342,000 in licensee income compared to approximately $4.1 million in processing and storage fee revenue and approximately $323,000 in licensee income for the first quarter of fiscal 2011. Licensee income for the three months ended February 29, 2012 consisted of approximately $337,000 in royalty income earned on the processing and storage of cord blood stem cell specimens in geographic areas where the Company has license agreements. The remaining licensee income related to installment payments of non-refundable up-front license fees from the licensees of the Company's umbilical cord blood program in Nicaragua. Licensee income for the three months ended February 28, 2011 principally consisted of approximately $318,000 in royalty income earned on the processing and storage of cord blood stem cell specimens in geographic areas where the Company has license agreements. The remaining licensee income related to an installment payment of a non-refundable up-front license fee from the licensee of the Company's umbilical cord blood program in Nicaragua.

The Company reported a net loss for the three months ended February 29, 2012 of approximately ($1.7 million), or ($0.15) per basic and diluted share, compared to net income of approximately $233,000, or $0.02 per basic and diluted share for the three months ended February 28, 2011. The decrease in net income for the three months ended February 29, 2012 principally resulted from the cancellation of the Bio-Stor Revenue Sharing Agreement resulting in a pre-tax charge for extinguishment of debt in the amount of approximately $1,200,000. Also, included in the decrease in net income is a 26% increase in selling, general and administrative expenses, due mainly to an increase of $191,000 in stock option compensation and the increase in sales and marketing initiatives. This is partially offset by a 12% decrease in cost of sales. In addition, research and development expenses were approximately $15,000 for the three months ended February 29, 2012, a decrease of approximately $21,000 or 59% in comparison to the same period in 2011.

At February 29, 2012, the Company had cash and cash equivalents of $4,320,073. The Company's cash decreased by approximately $2,000,000 during the first three months of fiscal 2012, primarily as a result of the cancellation of the Bio-Stor Revenue Sharing Agreement and the stock repurchase plan pursuant to which the Company has repurchased 415,117 shares of the Company's common stock for a total of approximately $754,000. The cancellation of the Bio Stor Revenue Sharing Agreement will result in an approximate $400,000 cash savings per year from a reduction of interest expense. As of February 29, 2012 the Company had no long-term indebtedness.

About Cryo-Cell International, Inc.

Cryo-Cell International, Inc. was founded in 1989 and was the world's first private cord blood bank to separate and store stem cells in 1992. Today, Cryo-Cell has over 240,000 clients worldwide from 87 countries. Cryo-Cell's mission is to provide our clients with the premier stem cell cryopreservation service and to support the advancement of regenerative medicine.

Cryo-Cell operates in a state-of-the-art Good Manufacturing Practice and Good Tissue Practice (cGMP/cGTP)-compliant facility, is ISO 9001:2008 certified and accredited by the AABB. Cryo-Cell is a publicly traded company. OTC:QB Markets Group Symbol: CCEL. Expectant parents or healthcare professionals may call 1-800-STOR-CELL (1-800-786-7235) or visit http://www.cryo-cell.com.

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Cryo-Cell Reports Financial Results for First Quarter 2012

Autologous bone marrow-derived mononuclear cell transplants can reduce diabetic amputations

Public release date: 18-Apr-2012 [ | E-mail | Share ]

Contact: David Eve celltransplantation@gmail.com Cell Transplantation Center of Excellence for Aging and Brain Repair

Tampa, Fla. (April. 18, 2012) Autologous (self-donated) mononuclear cells derived from bone marrow (BMMNCs) have been found to significantly induce vascular growth when transplanted into patients with diabetes who are suffering from critical limb ischemia caused by peripheral artery disease (PAD), a complication of diabetes. The team of researchers in Seville, Spain who carried out the study published their results in a recent issue of Cell Transplantation (20:10), now freely available on-line at http://www.ingentaconnect.com/content/cog/ct/.

"Critical limb ischemia in diabetic patients is associated with high rates of morbidity and mortality; however, neovascularization induced by stem cell therapy could be a useful approach for these patients," said study corresponding author Dr. Bernat Soria of the Andaluz Center for Biologic and Molecular Regenerative Medicine in Seville, Spain. "In this study we evaluated the safety and efficacy of inter-arterial administration of autologous bone marrow-derived mononuclear cells with 20 diabetic patents with severe below-the-knee arterial ischemia."

The researchers noted that surgical or endovascular revascularization options for patients such as those in the study are limited because of poor arterial outflow. Although optimum dose, source and route of administration were outstanding questions, proper BMMNC dose for best results was an issue that the researchers hoped to clarify. They subsequently used a dose ten times smaller than other researchers had used previously in similar studies.

According to the authors, the rationale for their study was that intra-arterial infusions of autologous BMMNCs contain endothelial progenitors that are locally profuse at severely diseased vascular beds in the lower limb. Their hope was that the BMMNCs could promote early and effective development of new vascularization.

Patients were evaluated at three months and twelve months post-transplantation.

"As previously reported, the one-year mortality rate for diabetic patients with PAD - most of which are associated with cardiac complications - has been found to be 20 percent," explained Dr. Soria. "Our study documented significant increases in neovasculogenesis for the majority of our study patients and a decrease in the number of amputations. However, overall PAD mortality for our patients was similar to that generally experienced."

The researchers concluded that BMMNC therapy for lower limb ischemia was a "safe procedure that generates a significant increase in the vascular network in ischemic areas" and promotes "remarkable clinical improvement."

"While this study did not demonstrate a significant effect on mortality, it does suggest an improvement in the quality of life based on limb retention as shown by the significant reduction in the number of amputations", said Amit N. Patel, director of cardiovascular regenerative medicine at the University of Utah and section editor for Cell Transplantation.

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Autologous bone marrow-derived mononuclear cell transplants can reduce diabetic amputations

Stemlogix Selects Butler Schein Animal Health to Distribute Versatile In-Clinic Stem Cell Therapy System to …

WESTON, Fla., April 17, 2012 (GLOBE NEWSWIRE) -- Stemlogix, a regenerative medicine company offering premier in-clinic stem cell therapy solutions to veterinarians, announced today that it has selected Butler Schein Animal Health(TM) to distribute its regenerative medicine system, stem cell therapy kits and other biological therapies. Butler Schein Animal Health(TM) - a Henry Schein Company - is the largest companion animal health distribution company in the U.S.

Based in the U.S., Stemlogix is an innovative leader in the rapidly emerging field of veterinary regenerative medicine. The Company develops and manufactures stem cell therapy kits and platelet rich plasma kits domestically according to FDA cGMP regulations. Stemlogix offers scientifically validated technologies and protocols that will enable veterinarians to provide their patients with affordable, versatile regenerative medicine solutions including adipose (fat) and bone marrow derived stem cells, platelet rich plasma (PRP) and cytokine therapies at the point-of-care, all in less than 90 minutes. The Company also offers stem cell banking and stem cell expansion services to veterinarians around the country.

Butler Schein Animal Health(TM) will now offer the Stemlogix regenerative medicine system to its network of over 26,000 veterinary clinics in the U.S., helping Stemlogix to expand its market presence across North America. "We are excited to be working with Butler Schein to offer the Stemlogix in-clinic regenerative medicine system to their vast network of veterinarians," said Kristin Comella, CEO of Stemlogix. "This partnership will enable Stemlogix to help standardize and advance the field of regenerative medicine."

Clinical research has shown that regenerative stem cell therapies have been safely and effectively used to treat degenerative diseases and acute tissue injuries including arthritis, laminitis, tendon injuries and ligament injuries. Stemlogix has developed an array of convenient, affordable, same-day regenerative therapies designed to achieve reproducible and superior clinical outcomes. Stemlogix also has developed an innovative technique to remove stem cell rich fat tissue from horses in a minimally invasive, scar-free method, called Equine VetLipo(TM).

About Stemlogix, LLC

Stemlogix is an innovative veterinary regenerative medicine company committed to providing veterinarians with the ability to deliver the best possible stem cell therapy to dogs, cats and horses at the point-of-care. Stemlogix provides veterinarians the ability to produce PRP and isolate regenerative stem cells from a patient's own fat tissue or bone marrow in their own clinic. Stemlogix is the first company to provide veterinarians with the ability to produce multiple cellular therapies using the same system and the company offers the most versatile regenerative medicine system available. Stemlogix has a full scale cGMP stem cell manufacturing facility and a scientific team with expertise in developing stem cell products, FDA compliance and clinical research. For more information about veterinary regenerative medicine please visit http://www.stemlogix.com.

About Butler Schein Animal Health(TM)

Butler Schein Animal Health (Butler Schein) -- the veterinary division of Henry Schein (Nasdaq: HSIC - News) is the leading companion animal health distribution company in the United States headquartered in Dublin, Ohio. Butler Schein employs approximately 900 team members including 300 field sales representatives and 200 telesales and customer support representatives. With 15 strategically positioned, state-of-the-art distribution facilities and 10 inside sales centers nationwide, we maintain 98%+ order-fill ratio, accomplishing our mission of providing the right product at the right place and at the right time.

Partnering with over 400 leading animal health manufacturers in the world, Butler Schein is positioned to bring the broadest selection of veterinary products and strategic solutions to veterinary professionals nationwide, including:

1.

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Stemlogix Selects Butler Schein Animal Health to Distribute Versatile In-Clinic Stem Cell Therapy System to ...