Approval of IB1001 would offer people with hemophilia B a choice of recombinant therapies

Inspiration Biopharmaceuticals Announces Filing of Biologics License Application (BLA) for IB1001, a Recombinant Factor IX Product for People with Hemophilia B

Approval of IB1001 would offer people with hemophilia B a choice of recombinant therapies

Cambridge, Mass., April 17, 2012 – Inspiration Biopharmaceuticals, Inc. today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of IB1001, an intravenous recombinant factor IX (rFIX) protein for the treatment and prevention of bleeding in individuals with hemophilia B. 

Based on the terms of its agreement with Ipsen (Euronext: IPN; ADR: IPSEY), Inspiration will receive a $35 million milestone payment associated with its filing of the BLA.  In return, Inspiration will issue a convertible note to Ipsen, bringing Ipsen’s fully diluted equity ownership position in Inspiration to approximately 43.5%.

Approval of IB1001 would represent a significant advance for the hemophilia community, including the estimated 75% of people living with hemophilia worldwide who do not have adequate access to currently available treatments. IB1001 would be the first recombinant therapy for people with hemophilia B introduced in more than 15 years.

Regulatory review is now pending in both the U.S. and Europe. Inspiration’s Marketing Authorization Application for IB1001 was accepted by the European Medicines Agency in September 2011.  The company is currently finalizing plans for additional regulatory filings and preparing for the commercial launch of IB1001.

“The introduction of recombinant factor IX was an important step forward in the treatment of hemophilia B, but a single product is not sufficient to meet the needs of all people affected by this disease,” said John P. Butler, Inspiration’s Chief Executive Officer. “At Inspiration, we are solely focused on the needs of people with hemophilia, and we are proud of the progress we have made towards bringing forward a new choice of treatment for patients. We plan to work closely with regulatory authorities both here in the U.S. and around the world to make IB1001 available as broadly and rapidly as possible.”

The IB1001 BLA filing includes a comprehensive set of pharmacokinetics safety, and efficacy data from a Phase 3 clinical trial in people affected by hemophilia B.  A surgery substudy was also included.

John Taylor, Co-Founder and Chairman of Inspiration, stated, “With sons affected by hemophilia B, Inspiration co-founder Scott Martin and I are acutely aware of the impact of limited treatment options on families. We believe more choice can help us achieve our mission to broaden access to care—increasing the supply of products, driving healthy competition, and supporting prophylaxis, which is rapidly becoming the standard of care in hemophilia. We believe that the approval of IB1001 will be the first step in our journey to make broader access to care a reality for thousands of individuals with hemophilia.”
About IB1001
IB1001 is an intravenous rFIX product being developed for the treatment and prevention of bleeding in individuals with hemophilia B.  IB1001 has completed pivotal Phase 3 clinical studies that support the filling of the BLA, conducted at study sites in the U.S., Europe and India.

To date, IB1001 has been well tolerated by patients and pharmacokinetic (PK) analyses have demonstrated non-inferiority to the one approved rFIX product currently marketed for the treatment of hemophilia B.  Confirmatory PK studies reported at the 53rd Annual Meeting of the American Society of Hematology showed no evidence of development of inhibitors during treatment periods ranging from 4 to 18 months.

Results recently presented at the 5th Annual Congress of the European Association for Haemophilia and Allied Disorders demonstrated that IB1001 provided effective surgical hemostasis in study participants with hemophilia B undergoing major surgical procedures.

About Inspiration Biopharmaceuticals
Inspiration Biopharmaceuticals is exclusively dedicated to developing treatments for hemophilia, with a primary mission to broaden access to care by providing safe and effective recombinant therapies and advancing innovation for people living with hemophilia. Inspiration has a broad portfolio of recombinant hemophilia product candidates, which includes one under review by the FDA and EMA for marketing approval in the U.S. and Europe, one in late-stage clinical development, and two preclinical programs.

Inspiration’s lead product candidates are IB1001 and OBI-1, an intravenous recombinant porcine factor VIII (FVIII) product being developed for the treatment of individuals with congenital hemophilia A who have developed inhibitors against human FVIII, and for individuals with acquired hemophilia.  Inspiration has earlier-stage development programs focused on human recombinant factor VIIa (rFVIIa) for individuals with either hemophilia A or hemophilia B who have developed inhibitors or those with factor VII deficiency, and human recombinant FVIII for individuals with hemophilia A.

Inspiration’s senior management team has broad experience and expertise in hemophilia product development, biologics manufacturing and the successful commercialization of products to treat hemophilia and other rare diseases.

In January 2010, Inspiration entered into a strategic agreement with Ipsen (EURONEXT: IPN; ADR: IPSEY), leveraging the combined expertise and resources of the two companies, to develop a broad portfolio of hemophilia products. As announced in late August 2011, Ipsen and Inspiration extended their agreement to create a hemophilia business unit structure that will act as the exclusive sales organization for all hemophilia products commercialized under the Inspiration brand in Europe. For further information on Inspiration, please visit http://www.inspirationbio.com.
Contacts:
Media
Kate Lewis
Dan Quinn
Feinstein Kean Healthcare
Tel: +1-617-577-8110
Email: kate.lewis@fkhealth.com
dan.quinn@fkhealth.com

Company
Gordon H. Busenbark
Senior Vice President, Chief Financial Officer
Tel: +1-617-588-1802

Positive Data on Recombinant Factor IX for People with Hemophilia B Who Have Undergone Major Surgical Procedures

Inspiration Biopharmaceuticals Highlights Positive Data on its Recombinant Factor IX for People with Hemophilia B Who Have Undergone Major Surgical Procedures

ROME, Feb. 22, 2012 /PRNewswire/ — Inspiration Biopharmaceuticals, Inc. (Inspiration) today announced clinical results for the Company’s lead product candidate, an intravenous recombinant factor IX (FIX) product being investigated for the treatment and prevention of bleeding in individuals with hemophilia B.  The data demonstrated that Inspiration’s FIX product provided effective surgical hemostasis in people with hemophilia B undergoing major surgical procedures.  The data were highlighted in a poster presentation at the 5th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD) in Rome, Italy.

In a poster titled, “Use of IB1001, a new investigational recombinant factor IX, in patients with hemophilia B undergoing major surgical procedures”, the newly reported data showed that a group of subjects who underwent major surgical procedures had effective control of bleeding with IB1001.  Estimated intra-operative blood loss was rated as expected or less than expected in all subjects, and IB1001 was well-tolerated with few adverse events. Fourteen subjects, ages 12 and above, were enrolled in the study. Twelve underwent orthopedic procedures, with one inguinal repair and one hysterectomy.  Subjects received either bolus or continuous infusion of IB1001 to support surgery, and for a minimum of three days post procedure.  Hemostasis was evaluated at 12 hours and 24 hours post procedure. Post-surgical hemostasis was considered adequate or superior at both evaluation points in all subjects.

Howard Levy, M.D., Ph.D., Senior Vice President and Chief Medical Officer of Inspiration commented, “We are very encouraged by the results of this surgery study.  Surgery is especially complicated for individuals with hemophilia due to the potential for significant blood loss.”

For the rest of the press release, click here.

Inspiration Biopharmaceuticals Initiates Second Pivotal Clinical Study of Innovative Hemophilia Therapy OBI-1

 From Inspiration Bio

Laguna Niguel, CA, November 28, 2011 – Inspiration Biopharmaceuticals, Inc. (Inspiration) today announced the initiation of patient enrollment in the second of two pivotal studies in the Company’s OBI-1 Accur8 clinical trial program. In the newly initiated clinical study, OBI-1, an intravenous recombinant porcine factor VIII (FVIII) product, will be evaluated for the treatment of individuals with congenital hemophilia A who have developed inhibitory antibodies (inhibitors) against their human FVIII replacement therapy. In achieving this milestone, Inspiration has received a $25 million milestone payment from the Ipsen Group (Euronext: IPN; ADR: IPSEY), under a partnership agreement signed with Ipsen in January 2010. In return, Inspiration has issued Ipsen a convertible note, bringing Ipsen’s fully diluted ownership position in Inspiration to 40.7%.

The OBI-1 pivotal clinical study is a prospective, non-randomized, open-label study evaluating the efficacy of OBI-1 for the treatment of serious bleeding episodes, including episodes that are a threat to a patient’s life or vital organs.

 Dr. Johnny Mahlangu, MD, Director of the Adult Hemophilia Comprehensive Care Unit at Johannesburg Hospital, and President of the South African Society of Hematology, commented, “There remains a significant unmet medical need when it comes to treating individuals with hemophilia A who have developed inhibitors. Current therapies do not reach the same level of efficacy as replacement therapy for non-inhibitor patients, leading to potential joint complications, increased risk of bleeding, pain and impact on the patient’s quality of life. Unlike available bypassing agents, OBI-1 facilitates the intrinsic hemostatic pathway, and therefore may allow clinicians to correlate activity and efficacy with FVIII levels (a surrogate for efficacy), enabling them to guide dosing and better predict treatment outcomes. We are pleased to have enrolled the first patient in this pivotal clinical study.”

Inspiration in-licensed OBI-1 from Ipsen as part of their January 2010 partnership agreement, whereby Inspiration is responsible for the clinical development, regulatory approval and commercialization of the product. Previously, in November 2010, Inspiration initiated the first pivotal study of OBI-1 for the treatment of individuals with acquired hemophilia A, a rare, potentially life-threatening autoimmune bleeding disorder caused by the development of inhibitors against endogenous FVIII. Results from the first patients in this clinical study were presented in a Scientific Session held in conjunction with the 23rd Congress of the International Society on Thrombosis and Haemostasis (ISTH) in July 2011. Enrollment in the OBI-1 acquired hemophilia clinical trial is ongoing.

John P. Butler, Chief Executive Officer of Inspiration, commented, “Inspiration is committed exclusively to driving innovation that can bring positive impact to the treatment of people with hemophilia. We now have OBI-1 in pivotal development for multiple indications. We also recently announced the filing of a Marketing Authorization Application (MAA) for our other lead program, IB1001, a recombinant factor IX product for the treatment of hemophilia B. These two late stage products, along with our preclinical programs for factor VIIa and FVIII deficiency, gives Inspiration one of the broadest pipelines for hemophilia treatment in the industry. As a company, we are committed to developing and commercializing an array of hemophilia products, which will provide value to physicians and to people living with the condition worldwide.”

About Hemophilia

Hemophilia is a bleeding disorder caused by low levels or the absence of a protein called a coagulation factor, essential for blood clotting. The two most common forms of hemophilia are types A and B. Hemophilia A is caused by a factor VIII deficiency and the congenital form occurs in ~1 out of every 5,000 male births. Hemophilia B is caused by factor IX deficiency and occurs in ~1 out of every 30,000 male births. Approximately 60% of persons with hemophilia have a severe condition, which results in frequent spontaneous bleeding episodes, in addition to serious bleeding after injuries. The annual market for hemophilia treatments is estimated at $8 billion worldwide.

Approximately one-third of individuals with hemophilia A develop an immune reaction (inhibitors) to human FVIII, and can no longer respond to replacement treatment with the coagulation factor. Current therapies, specifically human factor VIIa (NovoSeven®) and FEIBA, work by bypassing the natural hemostatic pathway.

About OBI-1

OBI-1, a recombinant form of porcine FVIII which may possess low cross reactivity to antihuman FVIII antibodies, is a replacement therapy, facilitating the intrinsic hemostatic pathway. This should allow clinicians to correlate activity and efficacy with FVIII levels, a surrogate for efficacy in hemophilia, and therefore guide dosing to better monitor and predict treatment outcomes. OBI-1 presents a unique and alternative approach to address the needs of individuals who have developed inhibitors to FVIII and is highly desired by the medical community.

For more information about enrolling in one of Inspiration’s clinical trials, please visit www.hemophiliaregistry.com or call 1-800-361-3227. For more information on the ongoing clinical studies, please visit http://www.clinicaltrials.gov.

About Inspiration Biopharmaceuticals

Inspiration Biopharmaceuticals is dedicated exclusively to developing treatments for hemophilia, with a primary mission to broaden access to care, including prophylactic therapy, and to improve the treatment of individuals with inhibitor complications. Inspiration has a broad portfolio of recombinant hemophilia products, which includes two products in late-stage clinical development and two preclinical programs.

Inspiration’s two lead programs are IB1001, an intravenous recombinant factor IX (FIX) product being developed for the treatment and prevention of bleeding in individuals with hemophilia B, and OBI-1, an intravenous recombinant porcine factor VIII (FVIII) product being developed for the treatment of individuals with congenital hemophilia A who have inhibitors against human FVIII and for individuals with acquired hemophilia A. Inspiration recently submitted its first marketing application for IB1001 in Europe, with a subsequent regulatory filing planned in the U.S in the first half of 2012. Earlier-stage preclinical programs at Inspiration are focused on human recombinant factor VIIa (FVIIa), for individuals with either hemophilia A or hemophilia B who have developed inhibitors, and for individuals with factor VII deficiency; and human recombinant FVIII, to treat individuals with hemophilia A.

Inspiration has extensive expertise and experience in hemophilia product development, biologics manufacturing, regulatory approval and global commercialization. The Company’s senior leadership was directly responsible for the development and commercialization of the majority of hemophilia products currently on the market.

In addition, in January 2010, Inspiration entered into a strategic partnership with the Ipsen Group (EURONEXT: IPN; ADR: IPSEY), leveraging the combined expertise and resources of the two companies, to develop a broad portfolio of hemophilia products. As announced in late August 2011, Ipsen and Inspiration extended their partnership to create a hemophilia business unit structure that will act as the exclusive sales organization for all hemophilia products commercialized under the Inspiration brand inEurope. For further information on Inspiration, please visit http://www.inspirationbio.com.

Contacts:

Company
Gordon H. Busenbark
Senior Vice President, Chief Financial Officer
Email: gbusenbark@inspirationbio.com

Media
Justin Jackson
Michelle Szwarcberg
Burns McClellan
Tel: +1-212-213-0006
Email: jjackson@burnsmc.com
mszwarcberg@burnsmc.com

Inspiration Biopharmaceuticals Announces Acceptance of European Marketing Authorization Application for IB1001 for the Treatment of Hemophilia B

Press Release Source: Inspiration Biopharmaceuticals, Inc. On Monday October 3, 2011, 1:00 am EDT

LAGUNA NIGUEL, Calif., Oct. 3, 2011 /PRNewswire/ — Inspiration Biopharmaceuticals, Inc. (Inspiration) today announced that the European Medicines Agency (EMA) has validated and accepted the filing of the Marketing Authorization Application (MAA) for Inspiration’s IB1001, a recombinant factor IX (FIX) product for the treatment and prevention of bleeding in individuals with hemophilia B.  In doing so, the EMA has verified that it will begin its regulatory review process of the MAA.

The application includes safety and efficacy data from Inspiration’s clinical program for IB1001, which was conducted in the U.S., Europe, Israel and India.

Based on Inspiration’s partnership agreement with the Ipsen Group (Euronext:IPN – News), which was signed in January 2010, by receiving the IB1001 MAA submission acceptance for review from the EMA, Inspiration will receive a $35 million milestone payment from Ipsen.  In return, Inspiration will issue a convertible note to Ipsen, bringing Ipsen’s fully diluted equity ownership position in Inspiration to approximately 38%.

In late August, Ipsen and Inspiration extended their partnership to create a hemophilia business unit structure that will act as the exclusive sales organization for all hemophilia products commercialized under the Inspiration brand in Europe.

“The MAA submission for our lead program, IB1001, is Inspiration’s first product approval regulatory filing, and a key step in the Company’s transformation toward becoming a commercial-stage company,” stated John Taylor, Co-Founder and Chairman of Inspiration.  ”We believe the hemophilia community would like to see greater product choice. Currently, individuals with hemophilia B only have one marketed recombinant FIX treatment option.  Our IB1001 program is designed to increase product supply, provide patient choice, and help achieve our mission to broaden access to care worldwide.”

About IB1001

IB1001, Inspiration’s lead product candidate, is an intravenous recombinant FIX product being developed for the treatment and prevention of bleeding in individuals with hemophilia B.  IB1001 has completed the pivotal Phase 3 clinical testing for the European regulatory submission, while clinical testing for the U.S. regulatory submission is ongoing.  To date, IB1001 has been well-tolerated by patients and pharmacokinetic results have demonstrated non-inferiority to the one approved recombinant FIX product currently available for the treatment of hemophilia B.

About Inspiration Biopharmaceuticals

Inspiration Biopharmaceuticals is dedicated exclusively to developing treatments for hemophilia, with a primary mission to broaden access to care, including prophylactic therapy, and to improve the treatment of individuals with inhibitor complications.  Inspiration has a broad portfolio of recombinant hemophilia products, which includes two products in late-stage clinical development and two pre-clinical programs.

Inspiration’s lead product candidates are IB1001, an intravenous recombinant factor IX (FIX) product for the treatment and prevention of bleeding in individuals with hemophilia B, and OBI-1, an intravenous recombinant porcine factor VIII (FVIII) product for the treatment of individuals with congenital hemophilia A who have developed inhibitors against human FVIII and for individuals with acquired hemophilia.  Both products are in advanced clinical development.  Earlier-stage preclinical programs at Inspiration are focused on human recombinant factor VIIa (FVIIa), for individuals with either hemophilia A or hemophilia B who have developed inhibitors, and for individuals with factor VII deficiency; and human recombinant FVIII, to treat individuals with hemophilia A.

Inspiration has extensive expertise and experience in hemophilia product development, biologics manufacturing, regulatory approval and global commercialization. The Company’s senior leadership was directly responsible for the development and commercialization of the majority of hemophilia products currently on the market.  

In addition, in January 2010, Inspiration entered into a strategic partnership with the Ipsen Group, leveraging the combined expertise and resources of the two companies, to develop a broad portfolio of hemophilia products.  As announced in late August 2011, through an extension of the Company’s existing partnership with Ipsen, Inspiration will be commercializing its hemophilia product portfolio in Europe, utilizing a hemophilia business unit structure being established within Ipsen’s existing European commercial organization. For further information on Inspiration, please visit http://www.inspirationbio.com.

Ipsen’s Partner Inspiration Biopharmaceuticals Announces Non-Inferiority Of IB1001, Its Recombinant Factor IX For Hemophilia B

Ipsen (Paris:IPN) (Euronext: IPN, ADR: IPSEY) announced that its partner Inspiration Biopharmaceuticals, Inc. (Inspiration) presented pharmacokinetic (PK) data on its lead product, IB1001, a recombinant factor IX (FIX) for the treatment and prevention of bleeding in individuals with hemophilia B. According to Inspiration, results of the Phase 1 portion of an ongoing IB1001 clinical study demonstrated non-inferiority of IB1001 in achieving overall levels of replacement factor compared to BeneFIX®, the only approved recombinant FIX product for the treatment of hemophilia B. Currently, IB1001 is in Phase 3 and safety and efficacy results are expected later this year. 

The clinical results were presented at the 4th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD) in Geneva, Switzerland, in a poster presentation titled, “Pharmacokinetics of IB1001, a New Recombinant Factor IX”1.

Marc de Garidel, Chairman and Chief Executive Officer of Ipsen said:
“Pharmacokinetic results presented by our partner Inspiration Biopharmaceuticals emphasize the encouraging medical potential of IB1001, a promising factor IX for the treatment of hemophilia B, a disease for which access to adequate care is a significant unmet medical need globally.”

About the study
The randomized, double-blind, cross-over PK protocol was designed to show non-inferiority of IB1001 compared to the only marketed recombinant FIX product. The study enrolled 32 individuals with severe hemophilia B. Individuals in the study were infused with either IB1001 or the comparator, and their FIX levels were assessed at different time intervals. After a predetermined time period, individuals received the second product and FIX levels were assessed at the same time points.

Inspiration is continuing to recruit patients for the Phase 3 portion of the Company’s IB1001 study, including for the treatment of patients undergoing major surgical procedures. For more information on the ongoing study, please visit http://www.clinicaltrials.gov/ct2/show/NCT00768287.

About Hemophilia

Hemophilia is a bleeding disorder caused by low levels or absence of a protein called a coagulation factor, essential for blood clotting. The two most common forms of hemophilia are types A and B. Hemophilia A is caused by a factor VIII deficiency and the congenital form occurs in ~1 out of every 5,000 male births. Hemophilia B is caused by factor IX deficiency and occurs in ~1 out of every 30,000 male births. Approximately 60% of persons with hemophilia have a severe condition, which results in frequent spontaneous bleeding episodes, in addition to serious bleeding after injuries. The annual market for hemophilia treatments is $7.5 billion worldwide.

About IB1001

IB1001, Inspiration’s lead product candidate, is an intravenous recombinant FIX product being developed for the treatment and prevention of bleeding in individuals with hemophilia B. IB1001 currently is in pivotal Phase 3 clinical testing. To date, IB1001 has been well-tolerated, and pharmacokinetic results have demonstrated non-inferiority to the one approved recombinant FIX product for the treatment of hemophilia B. Pending results from clinical studies, regulatory approval and commercialization, IB1001 is expected to be the second recombinant FIX product to market, and thereby to increase product supply and access to care worldwide.

The Group also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to the Group’s activities and financial results.

The Group expressly disclaims any obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. The Group’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers.

1 Authors of the poster presentation were Uri Martinowitz, M.D., of the Israeli National Hemophilia Center; Amy D. Shapiro, M.D., of the Indiana Hemophilia and Thrombosis Center; Doris V. Quon, M.D., Ph.D., of the Hemophilia Treatment Center at Orthopaedic Hospital (Los Angeles, CA); Miguel A. Escobar, M.D., of the University of Texas Houston Health Sciences Center; Christine Kempton, M.D., of Emory University School of Medicine (Atlanta, GA); Peter W. Collins, M.D., of the Arthur Bloom Haemophilia Centre University Hospital of Wales School of Medicine, Cardiff University (Cardiff, UK); Pratima Chowdary, M.D., of the Royal Free Hospital (London, UK); Michael Makris, M.D., of the Royal Hallamshire Hospital (Sheffield, UK); Pier M. Mannucci, M.D., of the University of Milan Haemophilia & Thrombosis Center; Massimo Morfini, M.D., of Azienda Ospedaliero – Universitaria Careggi (Florence, Italy); Leonard A. Valentino, M.D., of Rush University Medical Center (Chicago, IL); and Ed Gomperts, M.D., and Martin Lee, Ph.D., both of Inspiration Biopharmaceuticals.

Ipsen and Inspiration Biopharmaceuticals enter into partnership to create a world leading hemophilia franchise

• Portfolio covers all major hemophilia markets and worldwide sales could exceed $1.0 billion by 2020

• Following the exclusive in-licensing of Ipsen’s OBI-1 alongside its own IB1001, Inspiration’s portfolio now includes two recombinant protein products ready to enter Phase III in 2010 and two earlier development compounds for the treatment of bleeding disorders

• Ipsen to acquire initial 20% stake in Inspiration for $85 million with the potential to increase ownership up to 47% through up to $174 million in additional milestone-based funding.

Ipsen (Euronext:  FR0010259150; IPN) and Inspiration Biopharmaceuticals, Inc. (Inspiration) yesterday announced that they have entered into a partnership to create a world leading hemophilia franchise. The partnership is designed to leverage combined expertise and resources to advance a broad portfolio of recombinant proteins, which address all major hemophilia disorders in a unique way by focusing on two significant unmet needs: wider access to treatment with coagulation factors and treatment for inhibitor complications. The two lead product candidates are scheduled to begin Phase III clinical testing in 2010 including Ipsen’s recombinant porcine factor VIII, OBI-1 (for the treatment of patients with acquired hemophilia and hemophilia A who have developed an inhibitory immune reaction to human forms of factor VIII), and Inspiration’s recombinant factor IX product, IB1001 (for the acute and preventative treatment of bleeding in patients with hemophilia B). Combined with Inspiration’s novel proprietary technology and an early-stage pipeline of additional hemophilia factors, this broad and unique portfolio would provide greater access to care and fulfill unmet needs for patients suffering from bleeding disorders.

For more information on IPSEN, click here.
For more information on INSPIRATION BIOPHARMACEUTICALS, INC., click here.

Inspiration also has an open letter to the community, the letter can be read here.

The current PhaseII study on IB1001  has an estimated completion date of April 2010. (the study started Jan 2009). For more information of this clinical trial, click here.

For the completed clinical trial of OBI-1, click here.

for information on US Clinical Trails in your state, click here.