Vandy
09-19-2001, 05:27 PM
Guilford Pharmaceuticals Inc. (NASDAQ:GLFD), announced today that Amgen (NASDAQ:AMGN) has elected to terminate its agreement with Guilford and return all rights to the neuroimmunophilin ligand technology it licensed from Guilford in 1997.
Neuroimmunophilin ligands are a novel class of drugs developed by Guilford that may have the ability to cause nerve growth and repair. In preclinical studies conducted in research laboratories, neuroimmunophilin ligands have demonstrated promising results suggesting they may have utility in a broad range of clinical indications, including Parkinson's disease, age-related cognitive impairment, and spinal cord injury.
"We've enjoyed a very productive relationship with Amgen," said Dr. Craig R. Smith, President and Chief Executive Officer. "Over the course of our collaboration, we've learned a great deal about our neuroimmunophilin ligands and are committed to the further development and commercialization of this technology."
advertisement
In July 2001, Guilford reported preliminary results of the first clinical evaluation of a neuroimmunophilin ligand, 'NIL-A' in the treatment of Parkinson's disease. The clinical trial, which was conducted by Amgen, was a Phase II, randomized, double-blind, placebo-controlled evaluation of the safety, pharmacokinetics and efficacy of NIL-A in patients with mild to moderate Parkinson's disease. The results from this study suggested that NIL-A was well tolerated at doses up to 1,000 mg taken orally four times a day for 6 months, but did not produce a substantial reversal of the motor symptoms of Parkinson's disease.
"The Phase II clinical trial of NIL-A was the first clinical evaluation of our neuroimmunophilin ligand technology, and was an important exploratory study," continued Dr. Smith. "Although NIL-A did not meet its primary endpoint and produce a significant reversal in the motor symptoms of Parkinson's disease, we were encouraged that NIL-A was well tolerated. Our evaluation of the secondary endpoints in the trial suggested there may have been some benefit for certain of the non-motor symptoms of Parkinson's disease. However, these results are preliminary and will require additional study to confirm their significance. Furthermore, we've obtained encouraging results with neuroimmunophilin ligands in a variety of additional preclinical disease models, suggesting this technology may have application in a number of other clinical indications."
About Neuroimmunophilins
In 1990, scientists led by Dr. Solomon Snyder, Director of the Department of Neuroscience at Johns Hopkins Medical School and a co-founder of Guilford, discovered that certain immunosuppressive drugs were able to induce nerve growth in both test tube and animal experiments. After licensing the rights to this technology, Guilford scientists designed a series of novel, proprietary drugs, called neuroimmunophilin ligands, which possessed potent neurotrophic activity but which were not immunosuppressive.
Since this initial discovery, Guilford's neuroimmunophilin ligands have demonstrated neurotrophic activity in a number of animal models of Parkinson's disease and other acute and chronic neurological diseases and conditions. Results from some of these studies have been published in The Proceedings of the National Academy of Sciences and Nature Medicine. Several different laboratories have now confirmed the neurotrophic activity of neuroimmunophilin ligands in models of Parkinson's disease and peripheral nerve damage.
A large number of patents have been issued to Guilford covering the use and composition of several different classes of neuroimmunophilin ligands. The rights to this intellectual property have now been returned to Guilford by Amgen.
Guilford Pharmaceuticals Inc. is a pharmaceutical company engaged in the development of biopolymer-based therapeutics for surgeons and novel products for the diagnosis and treatment of neurological disorders.
This press release contains forward-looking statements that involve risks and uncertainties, including those described in the section entitled "Risk Factors" contained in the Company's Registration Statement on Form S-3 dated June 21, 2001, that could cause the Company's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. Among other things, there can be no assurance that NIL-A or other neuroimmunophilin ligands will be shown in clinical trials to be safe and effective for the treatment of Parkinson's disease or other conditions.
Neuroimmunophilin ligands are a novel class of drugs developed by Guilford that may have the ability to cause nerve growth and repair. In preclinical studies conducted in research laboratories, neuroimmunophilin ligands have demonstrated promising results suggesting they may have utility in a broad range of clinical indications, including Parkinson's disease, age-related cognitive impairment, and spinal cord injury.
"We've enjoyed a very productive relationship with Amgen," said Dr. Craig R. Smith, President and Chief Executive Officer. "Over the course of our collaboration, we've learned a great deal about our neuroimmunophilin ligands and are committed to the further development and commercialization of this technology."
advertisement
In July 2001, Guilford reported preliminary results of the first clinical evaluation of a neuroimmunophilin ligand, 'NIL-A' in the treatment of Parkinson's disease. The clinical trial, which was conducted by Amgen, was a Phase II, randomized, double-blind, placebo-controlled evaluation of the safety, pharmacokinetics and efficacy of NIL-A in patients with mild to moderate Parkinson's disease. The results from this study suggested that NIL-A was well tolerated at doses up to 1,000 mg taken orally four times a day for 6 months, but did not produce a substantial reversal of the motor symptoms of Parkinson's disease.
"The Phase II clinical trial of NIL-A was the first clinical evaluation of our neuroimmunophilin ligand technology, and was an important exploratory study," continued Dr. Smith. "Although NIL-A did not meet its primary endpoint and produce a significant reversal in the motor symptoms of Parkinson's disease, we were encouraged that NIL-A was well tolerated. Our evaluation of the secondary endpoints in the trial suggested there may have been some benefit for certain of the non-motor symptoms of Parkinson's disease. However, these results are preliminary and will require additional study to confirm their significance. Furthermore, we've obtained encouraging results with neuroimmunophilin ligands in a variety of additional preclinical disease models, suggesting this technology may have application in a number of other clinical indications."
About Neuroimmunophilins
In 1990, scientists led by Dr. Solomon Snyder, Director of the Department of Neuroscience at Johns Hopkins Medical School and a co-founder of Guilford, discovered that certain immunosuppressive drugs were able to induce nerve growth in both test tube and animal experiments. After licensing the rights to this technology, Guilford scientists designed a series of novel, proprietary drugs, called neuroimmunophilin ligands, which possessed potent neurotrophic activity but which were not immunosuppressive.
Since this initial discovery, Guilford's neuroimmunophilin ligands have demonstrated neurotrophic activity in a number of animal models of Parkinson's disease and other acute and chronic neurological diseases and conditions. Results from some of these studies have been published in The Proceedings of the National Academy of Sciences and Nature Medicine. Several different laboratories have now confirmed the neurotrophic activity of neuroimmunophilin ligands in models of Parkinson's disease and peripheral nerve damage.
A large number of patents have been issued to Guilford covering the use and composition of several different classes of neuroimmunophilin ligands. The rights to this intellectual property have now been returned to Guilford by Amgen.
Guilford Pharmaceuticals Inc. is a pharmaceutical company engaged in the development of biopolymer-based therapeutics for surgeons and novel products for the diagnosis and treatment of neurological disorders.
This press release contains forward-looking statements that involve risks and uncertainties, including those described in the section entitled "Risk Factors" contained in the Company's Registration Statement on Form S-3 dated June 21, 2001, that could cause the Company's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. Among other things, there can be no assurance that NIL-A or other neuroimmunophilin ligands will be shown in clinical trials to be safe and effective for the treatment of Parkinson's disease or other conditions.
Sponsor
md1817
09-19-2001, 11:42 PM
Although the result of the Amgen trial was not what we were all hoping for, the findings were not negative, and I personally regard this as progress in developing new strategies to treat Parkinson's disease. The drug was well tolerated, there were some indications of positive effect, and the trial was very short- just 6 months. For the past 35 years we have been treating Parkinson's disease much the same way- by enhancing dopamine. The Amgen trial represented the first large scale attempt to actually encourage the brain to replace connections that had been damaged by the disease. More efforts of new methods of treatment will follow, some are underway now or are soon to start, and eventually they will be successful.
Bernie812
09-19-2001, 11:55 PM
Vandy,
Why the thumbs down? This is a good thing! Amgen was looking for an instant blockbuster and they didn't get it. If Amgen can buy blockbusters outright, why waste time reworking products. Guilford, on the other hand, sees big opportunity here. They need a blockbuster and are obviously now very excited at the prospects of moving ahead on their own.
Besides, the study was not a failure. The product was well tolerated and showed some efficacy, which is usually the goal of a phase II. That's not too bad for a first-time human trial. Instead of being dead, the product has new life. If Guilford has ideas about moving ahead with this, I say...............
GO GUILFORD!!!!!!!!!!!!!!!
Bernie812
Why the thumbs down? This is a good thing! Amgen was looking for an instant blockbuster and they didn't get it. If Amgen can buy blockbusters outright, why waste time reworking products. Guilford, on the other hand, sees big opportunity here. They need a blockbuster and are obviously now very excited at the prospects of moving ahead on their own.
Besides, the study was not a failure. The product was well tolerated and showed some efficacy, which is usually the goal of a phase II. That's not too bad for a first-time human trial. Instead of being dead, the product has new life. If Guilford has ideas about moving ahead with this, I say...............
GO GUILFORD!!!!!!!!!!!!!!!
Bernie812
Shaky John
09-20-2001, 01:38 PM
I'm with you Bernie. Go Guilford.
Googy
09-20-2001, 05:16 PM
Me to:Go Guilford !
Googy
Googy
Bruce
09-21-2001, 12:21 PM
I am sure any pd patients following this study, was hoping for a more successful result, but one of the main reasons it takes so long for a new drug to be marketed, is to satisfy the FDA the drug is safe to use over a long period of time.One thing to keep in mind, is, if this drug was available, is we would be taking this drug for the rest of our life. So it is going to take several years to develop that elusive cure for pd.
Bruce
Bruce