* Cortex Pharmaceuticals Inc., of Irvine, Calif., has entered into acooperative research and development agreement with the NationalInstitute of Health, of Bethesda, Md., for the initial clinicalevaluation of CX516 (AMPALEX) in Alzheimer's patients. Thestudy is to begin in the first quarter of 1997 with the objective ofdemonstrating its safety and tolerability. The trial will be arandomized, placebo-controlled, double-blind Phase 1/11a study with16 patients with mild to moderate Alzheimer's participating. Onethird will receive placebo and two thirds will receive escalating oraldoses of AMPALEX over a period of up to 28 days.
* Houghten Pharmaceuticals Inc., of San Diego, has signed a letter ofintent to sell its subsidiary, Multiple Peptide Systems, also of SanDiego, to a company formed by HPI's founder, Richard A. Houghten.Multiple Peptide Systems manufactures and markets GMP peptides,custom peptides and peptide combinatorial libraries for the researchcommunity. HPI will receive $2.25 million, $1.5 million of whichwill be received in 1997. The balance will be received in installmentspaid on the third, fourth and fifth anniversaries of the transaction. Forthe nine months ended Sept. 30, MPS generated approximately $1.7million in revenues.
* OraVax Inc., of Cambridge, Mass., entered into a licensingagreement with bioMerieux Vitek Inc., of Hazelwood, Mo., grantingbioMerieux exclusive worldwide rights to develop human diagnosticproducts incorporating a proprietary Oravax antigen. The antigen,CagA, is a component of Helicobacter pylori and is expected to beused in the development of diagnostic products for the detection ofH. pylori infection.
* Sibia Neurosciences Inc., of La Jolla, Calif., reported animalbehavioral studies have demonstrated a proprietary series of nicotinicacetylcholine receptor-selective compounds significantly reducedshort-and long-term memory deficits associated with aging, memory-impairing drugs and the loss of brain cholinergic neurons due to braininjury. The company plans to pursue development of the compoundsas potential therapeutics for Alzheimer's and other dementias.
SERAGEN'S PSORIASIS DRUG SUCCESSFUL IN PHASE IITRIAL
By Charles Craig
Seragen Inc. said data from a Phase II trial of its interleukin-2 (IL-2)fusion protein for psoriasis revealed 44 percent of patients receivingthe drug experienced more than 50 percent improvement from theautoimmune skin disease, which affects an estimated 6 million peoplein the U.S.
The Phase II U.S. study, involving 39 patients, was stopped in lateDecember 1995 when a participant experienced a blood clot. Thetrial was resumed in April 1996 after it was determined the adverseevent was not linked to the drug, which is identified as DAB389IL-2.(See BioWorld Today, Dec. 29, 1995, and April 5, 1996, p.1.)
Jean Nichols, Seragen's president and chief technical officer, said theIL-2 fusion protein achieved statistically significant results comparedwith a placebo in reduction of disease severity and lesion thickness.Treated patients also experienced quality of life improvements, suchas better performance of daily activities.
Nichols noted the successful conclusion of the delayed Phase II studyputs the drug back on track in clinical development for psoriasis.
The positive data also may help Seragen, of Hopkinton, Mass., attractmuch needed new financing. The company issued its third quarterfiscal report Thursday and noted it has enough money to fundoperations through the fourth quarter of this year.
Seragen's stock (NASDAQ:SRGN) closed Thursday up $0.125 to$1.75.
Cash Position Dwindling
As of Sept. 30, 1996, Seragen had $6.3 million in cash thanks to a $5million private placement of preferred stock and a patent licensingagreement with Sandoz Ltd., of Basel, Switzerland, related to anorgan transplant therapy.
Seragen reported a net loss of $8 million for the third quarter of 1996and $17.5 million for the first nine months of this year.
The IL-2 fusion protein is the company's lead product candidate andalso is under evaluation in Phase III trials for cutaneous T celllymphoma in collaboration with Eli Lilly and Co., of Indianapolis,which has rights to the drug for cancer.
Seragen's cash crunch constitutes a major challenge for its newmanagement team, which was assembled earlier this month.
Joining Nichols _ who was promoted from senior vice president ofclinical and regulatory affairs, research and development, andoperations _ is Reed Prior, former CEO of ActiMed Laboratories, aprivately held medical diagnostics company in Burlington, N.J. Reedis Seragen's new chairman, CEO and treasurer.
Resigning from Seragen were Chairman James Howell, CEO GeorgeMasters and Chief Financial Officer Thomas Konatich. Masters willremain a consultant.
In a prepared statement, Reed said the company "is actively seekingequity and other financing arrangements to fund future operations."
Psoriasis Studies Progressing
To advance its psoriasis program, Seragen already has begun a dose-escalation study involving 30 patients to pinpoint a dosage for aPhase III trial. Nichols said the range will vary at levels below 10micrograms per kilogram of body weight.
Results of the Phase II trial, which tested doses of 5, 10, and 15micrograms per kilogram, showed the drug achieved equal responserates at each level, but adverse events, while not significant, wereexperienced at the two highest dosages. Those side effects, Nicholssaid, included muscle pain, fever and nausea.
In addition to the dose escalation study, Seragen will conduct several,larger concurrent trials in preparation for the Phase III study.
In the Phase II trial, patients were treated three days per week for amonth. Twelve of 27 patients, or 44 percent, experienced more than50 percent improvement as measured by the standard psoriasisseverity index. Nichols said both skin surface area affected andseverity of disease were reduced significantly.
Only three of 12 patients in the placebo group showed improvement.
Psoriasis is a chronic skin disease characterized by periods ofexacerbation and remission. Current treatments involve continuousadministrations of immunosuppressive drugs, such as methotrexate,which can have toxic side effects.
Seragen's IL-2 fusion protein is designed to induce and prolongremissions, greatly reducing frequency of treatments and potential foradverse events.
The fusion protein combines portions of human IL-2 protein withfragments of diphtheria toxin. The molecule is designed to bind toIL-2 receptors present on activated lymphocytes and monocytes aswell as leukemia cells, lymphoma cells and some solid tumor cells.Once bound to the cell, the toxin portion of the molecule enters andkills the cell. Over activation of lymphocytes has been linked topsoriasis and other autoimmune diseases. n
(c) 1997 American Health Consultants. All rights reserved.