Predix to collaborate with Amgen on drug development
Predix will receive $20 million immediately, and says the deal could reach as much as $300 million.

Gali Weinreb 31 Jul 06 19:58

Predix Pharmaceutical Holdings Inc. has signed a cooperation agreement with biotechnology giant Amgen Inc. (Nasdaq: AMGN), one of the leaders in its field. The two companies will collaborate on the development of existing Predix preclinical compounds.
Under the agreement Amgen will be responsible for clinical development and commercialization of the product candidate. Predix will receive an upfront payment of $20 million, and it will also can earn additional fees of $287.5 million in milestone payments if certain clinical, regulatory and sales milestones are achieved. Predix believes that it could receive up $300 million, should the drug reach the market. Similarly, Predix will have the opportunity to receive potential double-digit royalties on future sales of products resulting from this collaboration, plus an option to promote a product resulting from this collaboration to specialty physicians in the US for a selected indication.

Predix’s S1P1 modulator has not been mentioned as part of its product pipeline since it is still at the pre-clinical stage. It is designed for treatment of autoimmune and inflammatory disorders, a field in which Amgen is considered to have an exceptionally strong presence.

The deal comes at an interesting juncture for Predix, which is about to merge with EPIX Pharmaceuticals (NASDAQ: EPIX), at a value of $90 million for Predix, after it abandoned its plans to make an IPO of its own at a much higher value. EPIX recently suffered a blow when international drug company Schering Plough (NYSE: SGP) waived its option to continue developing and marketing the molecule Vavoyst. The announcement sent EPIX stock down 7% that day, a fall which already includes a partial pricing of Predix’s activity. The US Food and Drug Administration (FDA) subsequently announced a further delay in approval for the product, which has already been postponed a number of times.

Published by Globes [online], Israel business news - www.globes.co.il - on July 31, 2006

Dubi

Fourth Predix drug candidate enters clinical trials
PRX-07034 is a treatment obesity and obesity and cognitive impairment associated with Alzheimer's disease or schizophrenia.

Gali Weinreb 8 Jun 06 11:53

Predix Pharmaceuticals Ltd. has begun Phase I clinical trials of a new drug, PRX-07034 for treating obesity and cognitive impairment (associated with Alzheimer's disease or schizophrenia). This is Predix’s fourth drug undergoing clinical trials. As with the previous drug candidates, PRX-07034 was developed at the company on the basis of its drug development platform for G-protein coupled receptors (GPCR). The company said it expects results of the PRX-07034 Phase I clinical trial by the end of the year.
PRX-07034, an oral pill, influences serotonin in the brain by acting on the human 5-HT6 receptor found mainly in the central nervous system. The company therefore expects the drug to have fewer side effects than existing treatments. Animal trials found that the drug improved the cognitive functioning of brain damaged test animals. For the treatment of obesity, the drug is designed to create the sensation of being sated. Animal trials found that it reduced the quantities of food consumed by test animals, thereby leading to weight loss.

Predix said there was no risk that the molecule would cause anorexia when used to treat cognitive impairment or obesity. Predix founder and CSO Dr. Oren Becker said, “Healthy systems in the body have control mechanisms that would probably prevent these negative side effects.”

Predix is under going a merger with EPIX Pharmaceuticals (Nasdaq: EPIX). The has three other drugs undergoing clinical trials, include an anxiety treatment in Phase III trials, whose results are due to be released in September; a treatment for Alzheimer’s disease in Phase II trials; and a treatment for pulmonary hypertension in Phase IIb trials. In 2007, anxiety treatment is also due to undergo clinical trials for the treatment of depression.

Published by Globes [online], Israel business news - www.globes.co.il - on June 8, 2006

Dubi

Predix Pharmaceuticals Achieves Full Enrollment for Phase III Clinical Trial of PRX-00023 in Generalized Anxiety Disorder; Company Expects Preliminary Efficacy, Safety, and Tolerability Data to be Available in Second Half of 2006

Last Update: 7:00 AM ET May 24, 2006

LEXINGTON, Mass. & RAMAT GAN, Israel, May 24, 2006 (BUSINESS WIRE) -- Predix Pharmaceuticals Holdings, Inc., which recently announced a definitive agreement to merge with EPIX Pharmaceuticals, Inc. (EPIX : EPIX Medical Inc
) , announced today that it has completed enrollment for its first Phase III trial of PRX-00023, the company's novel, long-acting 5-HT1A agonist, in patients with generalized anxiety disorder (GAD). This trial is the first of at least two pivotal trials expected in GAD.
"Our plan for this Phase III trial was to conclude the recruitment process by the end of June, and we have accomplished this milestone ahead of schedule. We believe that the rapid enrollment into this study illustrates the interest by both patients and physicians in new, well tolerated agents to treat anxiety. Based on our success with the enrollment for this trial, we continue to expect to provide preliminary Phase III data later this year," said Michael G. Kauffman, M.D., Ph.D., president and CEO of Predix Pharmaceuticals. "We look forward to updating the market and the clinical community once we have the data from this Phase III trial in hand."
Phase III Study Design
The Phase III trial is an eight-week, double-blind, placebo-controlled, multi-center study. The trial includes 25 sites in the United States and has enrolled approximately 310 patients with moderate-to-severe GAD randomized equally into one of two arms: a placebo arm, or a PRX-00023 treatment arm, in which patients receive a dose of 40 mg once daily for three days followed by 80 mg once daily for the remainder of the study. The primary objectives in this trial are to evaluate the efficacy of PRX-00023 in GAD as measured by the change from baseline in the HAM-A scale, and to assess the safety and tolerability of PRX-00023 during treatment of patients with GAD. The HAM-A scale is the FDA accepted standard for the evaluation of anti-anxiety activity, and it is used in all pivotal trials of drug candidates for the treatment of GAD. This trial will be the first of at least two pivotal trials with PRX-00023 for the treatment of GAD.
About PRX-00023
PRX-00023 is Predix's lead drug candidate and represents a novel, highly selective, non-azapirone class of 5-HT1A agonists discovered using the company's proprietary GPCR modeling, screening and lead optimization technology. Buspirone is currently the only 5-HT1A agonist approved in the United States for the treatment of anxiety, but is taken three times a day, requires approximately three to four weeks of dose adjustment to reach therapeutic levels, and may cause lightheadedness, nausea, headache and restlessness. Several other 5-HT1A agonists have shown efficacy in Phase II and III clinical trials in depression. However, most of these drugs belong to a chemical class of drugs called azapirones, and their development has been hindered by poor tolerability at therapeutic doses, need for dosing up to three times daily, and by the requirement of gradual dose escalation to effective doses because of side effects such as nausea, dizziness, and restlessness which are thought to be caused by azapirones binding to non-5-HT1A G-Protein Coupled Receptors (GPCRs).
In contrast, PRX-00023 is designed to have minimal affinity for the GPCRs believed to be associated with the side effects of 5-HT1A agonists that are in the azapirone chemical class, and to have a more convenient dosing profile than azapirones. PRX-00023 has a half-life of 12 hours, allowing it to be administered once daily.
The Journal of Medicinal Chemistry, the official peer-reviewed journal of the American Chemical Society, recently published a paper highlighting PRX-00023's novel discovery process as illustrative of a new paradigm in drug discovery utilizing in silico methods together with medicinal chemistry that resulted in a substantially reduced discovery timeline for this drug candidate.
About Predix Pharmaceuticals Holdings, Inc.
Predix, based in Lexington, MA, is a pharmaceutical company focused on the discovery and development of novel, highly selective, small-molecule drugs that target G-Protein Coupled Receptors (GPCRs) and ion channels. Using its proprietary drug discovery technology and approach, Predix has advanced three internally discovered drug candidates into clinical trials and has six additional programs in preclinical development and discovery. Predix is expected to complete the first of at least two pivotal Phase III clinical trials for generalized anxiety disorder for its lead drug candidate, PRX-00023, in the second half of 2006. Predix has two other clinical-stage drug candidates: PRX-03140 for the treatment of Alzheimer's disease, which is expected to enter Phase IIa later this year; and, PRX-08066 for the treatment of pulmonary hypertension (PH) and PH associated with chronic obstructive pulmonary disease, which recently completed a Phase Ib trial and is expected to enter Phase IIa in mid-2006. Additional information about Predix can be found on the company's website at www.predixpharm.com.

Dubi

Predix preliminary clinical trial of hypertension drug - successful
Predix Pharmaceuticals recently merged with the Nasdaq-traded EPIX Pharmaceuticals.

Gali Weinreb 20 Apr 06 16:03

Drug development company Predix Pharmaceuticals, announced today it had successfully completed a Phase Ib clinical trial to study the pharmacodynamics and tolerability of PRX-08066, a drug developed for treatment of elevated pulmonary artery pressures induced by low oxygen levels.
Founded in Israel and now registered in the US, Predix recently announced a definitive agreement to merge with EPIX Pharmaceuticals (Nasdaq: EPIX), in a agreement reflecting a value for Predix of $90 million. Epix develops imaging pharmaceuticals targeted at the molecular level for MRI imaging. The company has a pipeline of diagnostic pharmaceutical products for detection of various vascular and coronary diseases.

Published by Globes [online], Israel business news - www.globes.co.il - on April 20, 2006

Dubi

Why was Predix’s value halved?
Shareholders apparently decided to forego value on paper for cash.

Gali Weinreb 5 Apr 06 12:48

On Monday, Predix Pharmaceuticals Holdings Inc. announced a merger agreement with Epix Pharmaceuticals Inc. (Nasdaq: EPIX). The agreement will give Predix access to Epix’s cash lifeline of $125 million, and to the US capital market, which Predix wanted. The only astonishing figure in the deal is the company value of $90 million for Predix.
In October 2005, Predix tried to go public on Nasdaq at a company value of $230 million, but withdrew the IPO, on the grounds that the market conditions were not conducive to success. Market sources claimed that the period was weaker than average, but that companies were able to hold successful issues as planned.

Predix is conducting Phase III clinical trials of a drug with a big market: anxiety disorders. The company says its drug can also treat depression, and it has two other drugs undergoing clinical trials, one for treating Alzheimer’s disease, and the other for hypertension. $90 million is a low valuation not only relative to the company’s ambition at the time of its planned IPO, but also for companies carrying out Phase III clinical trials.

This is usually the stage at which a company signs distribution agreements with international pharmaceutical companies, and may be acquired by them. Epix isn’t a pharmaceutical company and isn’t an especially successful company, at least in terms of its market cap. The main thing it has is cash.

Why wasn’t Predix able to obtain a distribution agreement with a leading pharmaceutical company or hold an IPO at the company value it wanted? First of all, there is the large number of small late-stage companies seeking investment, some of which simply fall off the radar screen. Leader Capital Markets medical market analyst Uri Hershkovitz adds that the anxiety treatment market is especially crowded, and despite its $10 billion size, it has not seen much growth in recent years, and therefore may attract little investor interest.

CE Unterberg Towbin life sciences analyst Andrew Fein recently visited Israel and knows Predix. He says there are many effective drugs in the anxiety treatment market, and even though there is no drug considered perfect, and there is room for more drugs, the market does not excite the drug companies or investors in the way that a market for which there is no effective treatment does, even if the latter is a smaller market or the drug is less advanced.

Hershkovitz and Fein agree that a company’s value should be a function of its ability to offer patients a better treatment than other drugs, and apparently Predix found it difficult to persuade anyone that it was offering a substantial improvement. The results of the company’s Phase III clinical trial, due in September, may be more persuasive.

On the other hand, BioLineRx Ltd. CEO Dr. Morris Laster, who also co-founded Keryx Biopharmaceuticals Inc. (Nasdaq: KERX;) and XTL Biopharmaceuticals Ltd. (Nasdaq:XTLB); LSE: XTL; TASE:XTL), believes that Predix made an excellent deal with Epix. “Although Predix held an issue at a lower value than it had hoped for, it obtained cash, which will help it promote its plans. Epix is not only a company with cash, but also revenue, which will greatly reduce Predix’s risk down the road. They may not have reached the value at which they wanted to go public, but I believe that this deal is better for them, and gives them the chance to raise their value above the one they wanted to get in the IPO.”

Predix’s shareholders will get $35 million in cash from the deal, if Predix’s Phase III clinical trial for its anxiety drug is successful, if it completes Phase II clinical trials for its depression, Alzheimer’s disease and hypertension treatments, or if it signs a strategic agreement with an international pharmaceutical company.

The real question that should be asked is why was Epix traded at less than its cash value? Epix is a company with regular revenue, and has two products in the pipeline. The company had a market cap of $250 million in mid-2005, but its share has been falling steadily since then, to reach its current price. The likely reason is that the US Food and Drug Administration (FDA) has repeatedly postponed approval of the company’s Vasovist molecule. Although Epix has other molecules on the market and in the pipeline, Vasovist is a promising molecule unlike any other. Epix has plummeted in value because it is unclear whether the company will be able to market another promising product in a reasonable timeframe in the event that Vasovist fails.

“We decided it was unwise to put all our eggs in one basket, and we decided to expand beyond diagnostics into therapies, and we’re seeking to buy a pharmaceutical company,” said Epix in March. Its share jumped 20% following the acquisition of Predix.

Published by Globes [online], Israel business news - www.globes.co.il - on April 5, 2006

Dubi

EPIX to acquire Predix for $90m
Later-stage products in the combined EPIX-Predix portfolio will be licensed to big pharma companies.
{Remember PRDX?}

Gali Weinreb 3 Apr 06 18:04

Cambridge, Mass-based EPIX Pharmaceuticals Inc. (NASDAQ: EPIX), a developer of innovative pharmaceuticals for magnetic resonance imaging (MRI), will acquire Predix Pharmaceuticals Holdings Inc.
EPIX will acquire Predix in a transaction valued at approximately $90 million, including the assumption of net debt at closing. In addition, Predix shareholders will be paid a possible milestone payment of $35 million in cash, stock or a combination of both based on the achievement of certain clinical or strategic milestones within a specified period of time.

Upon completion of the merger EPIX will issue to Predix stockholders shares of EPIX common stock such that Predix stockholders will own approximately 47% of the combined company‘s shares outstanding, and EPIX stockholders will own approximately 53%.

The combined company will have a broad pipeline of product candidates, an experienced management team and approximately $125 million in cash and marketable securities at the end of the first quarter.

Ramat Gan-based Predix was founded in 2000 by SVP Dr. Silvia Noiman, CSO Dr. Oren Becker, and Dr. Haim Aviv, the chairman and CEO of Pharmos Corporation (Nasdaq:PARS). (Aviv is no longer a shareholder). In August 2003, Predix merged with Physiome Sciences of the US.

In January 2005, Predix raised $43 million in a financing round led by Forward Ventures, Boston Millennia Partners, and CMEA Ventures, along with new investors Novel Bioventures, Yamanouchi Venture Capital, Yasuda and JAFCO Ventures, and previous investors OrbiMed Advisors LLC, S.R. One, Yozma Group, International Life Science Partners and PA Consulting. Despite its size, the round was oversubscribed. According to IVC data, Yozma owns 10% of the company.

In November 2005, Predix cancelled plans to go public, as demand for the share was reportedly less than half the $50 million that the company had hoped to raise at a company value of $232 million. Predix current market cap is $81.5 million.

EPIX is focused on the discovery and development of innovative pharmaceuticals for imaging that are designed to transform the diagnosis, treatment and monitoring of disease. EPIX‘s lead product Vasovist, a novel blood pool imaging agent, was approved by the European Commission for marketing in the 25 member countries of the European Union in October 2005, and is expected to be marketed in Europe by Schering AG. Vasovist also has been approved for sale in Switzerland. In the US, Vasovist was the subject of a second approvable letter received from the FDA in November, 2005. EPIX has a meeting with the FDA scheduled in early April 2006 to discuss a draft protocol for an additional Phase III trial of Vasovist. EPIX has additional imaging products in development, including EP-2104R, a thrombus-imaging agent in Phase II studies.

Predix is a privately-held pharmaceutical company focused on the discovery and development of novel, highly selective, small-molecule drugs that target G-Protein Coupled Receptors (GPCRs) and ion channels. Using its proprietary drug discovery technology and approach, Predix has advanced three internally discovered drug candidates into clinical trials and has six additional programs in preclinical development and discovery.

In addition to Vasovist, the combined company will have PRX-00023 in Phase III for anxiety, and expected to enter Phase II for depression in 2007; EP-2104R in Phase II for imaging arterial and venous blood clots; PRX-03140 which has completed Phase Ib trials and is expected to enter Phase II for Alzheimer‘s disease later this year; PRX-08066 in Phase Ib development for pulmonary arterial hypertension; and a portfolio of several pre-clinical product candidates.

The intention of the combined company is to license later-stage products to larger pharmaceutical or biotechnology companies at a point where it can maximize the value of these products; discussions regarding these potential partnerships have been initiated and are ongoing.

EPIX Interim CEO Michael Astrue said, "One of our goals has been to enter into a transformative transaction to make EPIX a growth company once again, with a robust portfolio of product candidates. The EPIX Board of directors has had the opportunity to evaluate many terrific privately-held therapeutics companies based on criteria we established last September. The result of this process is that we have selected Predix as the first and best choice to create a combined company that gives us many strong opportunities for growth.

"Predix has three promising products in the clinic, an innovative technology platform that has the ability to generate additional drug candidates, and a dynamic leadership team. We believe that this transaction will create a Massachusetts-based specialty pharmaceutical company with significant and lasting value.“

Predix president and CEO Dr. Michael G. Kauffman MD Ph.D said, "The combination of EPIX‘s imaging product portfolio and our therapeutic product pipeline diversifies our risks and provides us with the potential for nearer-term cash flow through royalty revenues. I am excited about the combined capabilities of the two companies because I believe that their complementary nature will enhance our ability to improve patients‘ lives by developing products that meet significant, unmet clinical needs and thereby drive significant shareholder value.“

Following the completion of the transaction, Kauffman will become CEO of the combined company.

Published by Globes [online], Israel business news - www.globes.co.il - on April 3, 2006

http://www.globes.co.il/serveen/globes/DocView.asp?did=1000079857

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Predix Pharmaceuticals Obtains Special Protocol Assessment for PRX-00023 Pivotal Study in Anxiety; Predix Also Initiates Phase Ib Clinical Trial for PRX-08066 in Pulmonary Arterial Hypertension

LEXINGTON, Mass. & RAMAT GAN, Israel--(BUSINESS WIRE)--Nov. 30, 2005--

Predix Pharmaceuticals, a drug discovery and development
company, announced today that under the Special Protocol Assessment
process, it has reached final agreement with the United States Food
and Drug Administration (FDA) on the design and statistical analysis
plan of its first pivotal study for PRX-00023, its 5-HT1A agonist and
lead product candidate, to treat generalized anxiety disorder (GAD).
In addition, Predix announced continued progress on its pipeline of
internally discovered product candidates with the initiation of a
Phase Ib clinical trial of PRX-08066, the company's novel
small-molecule 5-HT2B antagonist, in conditioned athletic adults with
transient pulmonary artery hypertension induced by a low oxygen
environment.



"We are very pleased to have reached final agreement with the FDA
on the Special Protocol Assessment for our Phase III clinical trial of
PRX-00023 in generalized anxiety disorder. With three of our
internally discovered product candidates currently in clinical trials
and an extensive pipeline of novel compounds in preclinical
development, we believe that our targeted drug discovery technology
and approach will enable us to continue to bring at least one new
product candidate into the clinic annually," said Michael Kauffman,
M.D., Ph.D., president and CEO of Predix.



Dr. Kauffman further commented, "The proof-of-concept trial of
PRX-08066 is an exciting event for Predix, as we believe there is a
significant need for improved treatment of pulmonary arterial
hypertension (PAH), a serious and often fatal cardiovascular disease.
Because of its selectivity - in preclinical models PRX-08066 reduces
only pulmonary and not systemic blood pressure - we believe that this
product candidate may lack the systemic blood pressure effects of
currently approved therapies for the disease."



PRX-00023 Phase III Study Design for GAD



Predix and the FDA had previously agreed upon the design and
primary and secondary endpoints for this Phase III trial, which was
initiated in August. The trial is an eight-week, double-blind,
placebo-controlled, multi-center study. The trial includes
approximately 20 sites in the United States and is expected to enroll
up to 310 patients with moderate-to-severe GAD who will be randomized
into one of two arms, consisting of approximately 155 patients each: a
placebo arm, or a PRX-00023 treatment arm, in which patients receive a
dose of 40 mg administered over a three-day period followed by a dose
of 80 mg once daily for the remainder of the study. The primary
objectives in this trial are to evaluate the efficacy of PRX-00023 in
GAD as measured by the change from baseline in the HAM-A scale, and to
assess the safety and tolerability of PRX-00023 during treatment of
patients with GAD. The HAM-A scale is the only FDA accepted standard
for the evaluation of anti-anxiety activity, and has been used in all
pivotal trials of drug candidates for the treatment of GAD. This trial
will be the first of at least two pivotal trials with PRX-00023 for
the treatment of GAD.



About PRX-00023



PRX-00023 is Predix's lead product candidate and represents a
novel, highly selective , non-azapirone class of 5-HT1A agonists
discovered using PREDICT(TM), the company's proprietary G-Protein
Coupled Receptors (GPCR) modeling, screening and lead optimization
technology. Buspirone is currently the only 5-HT1A agonist approved in
the United States for GAD but is generally taken three times a day,
requires approximately three weeks of dose adjustment to reach
therapeutic levels, and may cause lightheadedness and nausea. Several
other 5-HT1A agonists have shown efficacy in Phase II and III clinical
trials in depression. However, most of these drugs belong to a
chemical class of drugs called azapirones and their development has
been hindered by poor tolerability at therapeutic doses, rapid
metabolism, resulting in a short half-life and, therefore, requiring
multiple daily dosing, and the requirement of slow dose escalation to
effective doses because of nausea and lightheadedness, which are
thought to be caused by their binding to off-target G-Protein Coupled
Receptors (GPCRs).



In contrast, PRX-00023 is designed to have minimal affinity for
the GPCRs associated with the side effects of 5-HT1A agonists that are
in the azapirone chemical class, and to have a more convenient dosing
profile than azapirones.



PRX-08066 in PAH



PRX-08066 is a novel, highly selective, oral 5-HT2B antagonist
being developed for PAH. Over the past decade, the 5-HT2B receptor has
been shown to be linked to the development and progression of PAH,
including cases associated with the use of certain diet drugs in
humans. PRX-08066 is the first 5-HT2B antagonist being developed for
PAH and has completed two Phase I clinical trials in healthy
volunteers. The first Phase I clinical trial was a randomized,
placebo-controlled, double-blind, single-dose escalation study with 24
subjects. Over a dose range from 25 mg to 800 mg, PRX-08066 was
well-tolerated and there were no serious adverse events or liver
toxicity issues associated with treatment. A separate 14-day,
multiple-dose Phase I clinical trial in healthy volunteers showed that
PRX-08066 was well-tolerated. Preliminary pharmacokinetic data from
these two Phase I studies is consistent with once or twice daily oral
dosing.



Phase Ib Study Design in PAH



The Phase Ib clinical trial will study the pharmacodynamics and
tolerability of PRX-08066 in approximately 12 adults conditioned to
exercise at high altitudes, with elevated pulmonary artery pressures
induced by low oxygen levels (hypoxia). The trial will explore the
effects of PRX-08066 on pulmonary blood pressure and exercise
capacity.



This Phase Ib study features a randomized, double-blind,
three-period crossover design, where each subject receives drug or
placebo twice daily for 3 days in three separate periods, with an
interval of 1-2 weeks between visits. Pharmacodynamics of PRX-08066
will be characterized by the noninvasive measurement of pulmonary
artery blood pressure, right atrial pressure, cardiac index (i.e.,
cardiac output indexed to body size) and exercise capacity.



The trial is expected to be completed in mid- to late-2006, and if
the results are favorable, the initiation of a Phase II clinical trial
is anticipated in the second half of 2006.



About PRX-08066



PRX-08066 is Predix's third of three product candidates currently
in the clinic, all of which were internally discovered utilizing
computer-based G-Protein Coupled Receptor (GPCR) models and optimized
with integrated computational-medicinal chemistry. PRX-08066 is a
highly selective, small-molecule 5-HT2B antagonist being developed for
the treatment of PAH and other pulmonary disorders. PRX-08066 was
designed to provide both symptomatic improvement, through selective
dilation of diseased pulmonary blood vessels, and to slow disease
progression, by inhibiting the thickening of the pulmonary arteries
that occurs as PAH worsens.



PRX-08066 has demonstrated selective dilation of pulmonary blood
vessels in both acute and chronic pre-clinical models of PAH, as well
as disease-modifying effects in vivo and in in vitro signal
transduction pathway studies.



About Pulmonary Arterial Hypertension



Pulmonary Arterial Hypertension (PAH) is a serious and often fatal
cardiovascular disease affecting nearly 50,000 Americans and 50,000
Europeans. The disease is characterized by the elevation of pulmonary
artery blood pressure and progressive thickening and narrowing of the
blood vessels to the lungs, which can lead to heart failure. Symptoms
of PAH include fatigue after minimal exertion, dizzy spells, chest
pain, shortness of breath and fainting. The global market for PAH
drugs is growing rapidly, from approximately $600 million in 2004 to
an estimated $1 billion in 2010, as more patients with PAH are
diagnosed and initiated on drug therapy.



PAH results from the accelerated proliferation of
blood-vessel-associated smooth muscle cells that lead to the
constriction of pulmonary arteries. Blood supply to the lungs is
mediated by contraction of the right ventricle in the heart, which can
accommodate normal pulmonary blood pressures but is poorly suited to
tolerate the increased pulmonary pressures associated with the
arterial constriction that occurs in PAH. Over time, as the right
ventricle loses the ability to pump blood into the hypertensive
pulmonary system, the right ventricle heart muscle weakens and becomes
enlarged and dilated, eventually leading to heart failure in many
cases.



About Predix



Predix Pharmaceuticals Holdings, Inc. is a pharmaceutical company
focused on the discovery and development of novel, highly selective,
small-molecule drugs that target G-Protein Coupled Receptors (GPCRs)
and ion channels. Using its proprietary drug discovery technology and
approach, Predix has advanced three product candidates into clinical
trials and has six additional programs in preclinical development and
discovery. Predix initiated the first of at least two pivotal Phase
III clinical trials for generalized anxiety disorder for its lead drug
candidate, PRX-00023, in August 2005, and is conducting this Phase III
study under a Special Protocol Assessment agreed to with the FDA in
November 2005. Predix has two other clinical-stage drug candidates:
PRX-03140 for the treatment of Alzheimer's disease, entering Phase II,
and PRX-08066 for the treatment of pulmonary arterial hypertension,
now in Phase Ib.



Source: Predix Pharmaceuticals

Dubi

Predix’s Alzheimer’s treatment passes Ib clinical trial

The company withdrew a planned Nasdaq IPO in October until further notice.

Gali Weinreb 16 Nov 05 16:28

Predix Pharmaceuticals Inc. yesterday announced the success of Phase Ib clinical trials for its PRX-03140 treatment for mild-to-moderate Alzheimer's disease. Ib clinical trials are intermediate trials between Phase I safety trials and Phase II effectiveness trials on patients. The present trials showed the desired alterations in brain wave activity in patients. Alzheimer’s is characterized by slower brain-wave function; Predix’s drug aims at improving this condition. Phase II clinical trials are scheduled for early 2006.
Based in Ramat Gan, Predix develops new medicines through an integrated computational and medicinal chemistry platform, focusing on the discovery and development of novel, highly selective, small-molecule drugs that target G-Protein Coupled Receptors (GPCRs) and ion channels. The company’s most prominent drug, PRX-00023 for treating anxiety, is now undergoing Phase III clinical trials. PRX-03140 is the company’s second drug now undergoing testing.

Predix was founded in 2000 by SVP Dr. Silvia Noiman, CSO Dr. Oren Becker, and Dr. Haim Aviv, the chairman and CEO of Pharmos Corporation (Nasdaq:PARS). Aviv has not been active in Predix since 2002, and is no longer a shareholder.

In August 2003, Predix merged with Physiome Sciences of the US. In early October, Predix announced plans to hold an IPO on Nasdaq at a company value of $232 million, but then withdrew the plan until further notice. The company said it postponed the IPO because of market weakness, and a fall in the life science index on the US market. However, such postponements are usually due to an inability by a company to raise the desired amount of money.

Predix’s cash burn rate in the second half of 2005 is $19 million; it has $22 million in cash. The company is currently conducting advanced clinical trials, which further increases the cost of activities.

Published by Globes [online], Israel business news - www.globes.co.il - on November 16, 2005

http://www.globes.co.il/serveen/globes/DocView.asp?did=1000029932

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Predix Pharmaceuticals Announces Positive Findings from First Clinical Trial in Alzheimer's Disease Patients
PRX-03140 Preclinical Data to be Presented at the 35th Annual Meeting of the Society for Neuroscience
11/14/2005 9:00:14 AM

LEXINGTON, Mass. & RAMAT GAN, Israel, Nov 14, 2005 (BUSINESS WIRE) -- Predix Pharmaceuticals, a drug discovery and development company, announced today that PRX-03140, its highly selective, proprietary serotonin 4 (5-HT4) receptor agonist, showed the desired alterations in brain wave activity in patients with mild-to-moderate Alzheimer's disease and was well-tolerated in a recently completed 14-day Phase Ib clinical trial.

"The results of this Phase Ib trial in patients with Alzheimer's disease suggest that PRX-03140 is stimulating the 5-HT4 receptor in the brain and is eliciting the desired effects on brain waves consistent with approved drugs for Alzheimer's disease," said Stephen Donahue, M.D., vice president of clinical and regulatory affairs. "The excellent tolerability profile of PRX-03140 at all doses studied, combined with these early indicators of activity, are exciting preliminary results and warrant further evaluation in a Phase II trial."

Michael G. Kauffman, M.D., Ph.D., president and CEO of Predix, added, "We believe there is a significant unmet medical need for a well-tolerated, effective treatment for Alzheimer's disease that can be given once daily, and we are excited about the data we have seen from our experience with PRX-03140 in over 100 patients and healthy volunteers. We expect to initiate a Phase II dose-ranging trial in Alzheimer's disease patients early next year."

In parallel with these clinical development efforts, several positive studies of PRX-03140 in key preclinical models for memory, cognition, and disease modification are the subject of four poster presentations at the 35th Annual Meeting of the Society for Neuroscience in Washington, D.C. on November 12 - 16, 2005.

Study Design

This Phase Ib clinical trial was the second of two multiple dose studies with PRX-03140, Predix's proprietary drug candidate intended to treat Alzheimer's disease and other disorders of cognitive impairment. The primary objectives of these randomized, blinded Phase Ib studies in both healthy subjects and patients with mild-to-moderate Alzheimer's disease were to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound over a 14-day period. A total of 110 healthy volunteers and 12 Alzheimer's patients were enrolled in the Phase I clinical trials.

The Phase Ib study in patients was a double-blind, placebo-controlled trial, in which patients with mild-to-moderate Alzheimer's disease received a once-daily dose of the study drug or placebo for 14 days. The trial assessed the effects of PRX-03140 on quantitative electroencephalograms (EEGs), a measure of the electrical activity in the brain that has been used to characterize the effects of drugs that act on the central nervous system. In Alzheimer's disease patients, a specific EEG slow wave pattern has been linked with severity of dementia. With PRX-03140 treatment of Alzheimer's disease patients, there was a statistically significant improvement in the quantitative EEG slow wave pattern when compared with placebo. The short-term EEG effects observed with PRX-03140 treatment are similar to the published effects seen in patients that have an improvement in cognitive function after months of treatment with approved acetylcholinesterase inhibitor therapies for Alzheimer's disease. As expected, no change was seen in clinical parameters in this two-week study.

In the single and multiple dose studies in healthy volunteers and Alzheimer's patients, adverse events have all been mild or moderate in intensity, with no serious adverse events or adverse events resulting in discontinuations. No significant gastrointestinal adverse events were observed. The drug concentrations in humans increased in proportion to increases in dose, with a half-life of 10-12 hours, indicating that the drug may be administered once daily.

About PRX-03140

PRX-03140 is Predix's second of three clinical drug candidates discovered utilizing computer-based GPCR models and optimized with integrated computational-medicinal chemistry. PRX-03140 is highly selective for the 5-HT4 receptor in the brain, and preclinical studies have shown that it improves cognitive function, as well as increases levels of acetylcholine (ACh), soluble amyloid precursor protein (sAPP) and brain-derived neurotrophic factor (BDNF) in regions of the brain known to be important for memory.

About Alzheimer's Disease

An estimated 4.5 million Americans have Alzheimer's disease (AD), with epidemiological data suggesting a growing increase in disease incidence with an aging population. Currently, nearly one in 10 people over age 65 and as many as five in 10 people over age 85 have AD. According to recent studies, by the year 2050, the range of individuals with AD could be from 11 million to 16 million.

Acetylcholinesterase (AChE) inhibitors, a class of drugs approved for the treatment of Alzheimer's disease, are active in patients provided that endogenous production of ACh is sufficient to maintain local levels. As Alzheimer's disease progresses, ACh production declines, and brain levels of this critical neurotransmitter decline. In parallel with effective therapeutics in other neurodegenerative diseases (e.g., Parkinson's Disease), replacement of the prominent neurotransmitter lost in Alzheimer's disease should provide significant clinical benefit. However, neither ACh nor its components can be given in sufficient quantities to increase brain ACh levels with tolerable side effects. The search for agents which increase the production and/or release of ACh, which can be used alone or in combination with AChE inhibitors, may therefore yield a drug candidate with significant clinical benefit. Early data suggest PRX-03140 may meet this need.

About Predix

Predix Pharmaceuticals Holdings, Inc. is a pharmaceutical company focused on the discovery and development of novel, highly selective, small-molecule drugs that target G-Protein Coupled Receptors (GPCRs) and ion channels. Using its proprietary drug discovery technology and approach, Predix has advanced three drug candidates into clinical trials and has six additional programs in preclinical development and discovery. Predix initiated the first of at least two pivotal Phase III clinical trials for generalized anxiety disorder for its lead drug candidate, PRX-00023, in August 2005. It has two other clinical-stage drug candidates: PRX-03140 for the treatment of Alzheimer's disease, entering Phase II, and PRX-08066 for the treatment of pulmonary arterial hypertension.

SOURCE: Predix Pharmaceuticals

Dubi

Predix cancels Nasdaq IPO

Predix president and CEO Dr. Michael Kauffman: We’ll continue our clinical trials for our three flagship products.

Tali Tsipori 27 Oct 05 19:34

Only a few weeks after initial reports that drug developer Predix Pharmaceuticals Ltd. would cancel its planned IPO on Nasdaq, the company officially announced that its withdrawal. As “Globes” first reported, Predix said it was cancelling the IPO, due to what it termed “market conditions”.
Demand for Predix’s share was reportedly less than half the $55 million that the company had hoped to raise at a company value of just over $200 million.

Predix’s future operations will now be based mainly on the proceeds from private placements or public financing rounds.

Despite an uncertain future, Predix president and CEO Dr. Michael Kauffman is optimistic. “Although we decided to withdraw the IPO for now, we’ll continue our clinical trials for our three flagship products,” he said.

Published by Globes [online], Israel business news - www.globes.co.il - on October 27, 2005

Dubi

Predix may cancel IPO

The biotech company's flotation has been postponed from one day to the next for a week.

Tali Tsipori 26 Oct 05 20:39

Is the IPO of Israeli biotechnology company Predix liable to be cancelled? After the pricing date has been postponed from one day to the next for a week, it seems that the company will be forced to shelve is flotation plans. On the website IPO Home, the pricing day for the issue is described as D-T-D (day-to-day), a situation in which the lead underwriter has not received enough orders for the company's shares. In other words, there is a fair chance that the flotation will be postponed or even cancelled altogether. Predix seeks to raise $55 million at a company value of $232 million.
The lead underwriters for the flotation are UBS Investment Bank and Deutsche Bank. Co-managers are CIBC World Markets and ThinkEquity Partners.

Published by Globes [online], Israel business news - www.globes.co.il - on October 26, 2005

http://www.globes.co.il/serveen/globes/docview.asp?did=1000022663&fid=942

Dubi

A pity.Would have been a steal at $ 10.
Dubi

Predix Pharma pulls IPO, citing weak market

http://yahoo.reuters.com/financeQuoteCompanyNewsArticle.jhtml?duid=mtfh14708_2005-10-26_19-38-24_wen...

>>
Wed Oct 26, 2005 03:38 PM ET

NEW YORK, Oct 26 (Reuters) - Predix Pharmaceuticals Holdings Inc. on Wednesday withdrew its planned initial public offering, citing "market conditions," according to a statement from the company.

The Lexington, Massachusetts-based company is developing drugs to treat conditions including anxiety and hypertension. It had aimed to raise $55 million to fund development through the IPO.

It had planned to list on the Nasdaq under the symbol PRDX .
<<

Predix postpones

Predix had been supposed to float already. It wants to raise between $50 million and $60 million in proceeds from the IPO by selling million common shares for between $10 and $12 each. The company value will be in the range of $211 million to $253 million, assuming all goes well.

(#msg-8212420)

Dubi

Predix IPO postponed

Predix was expected to raise $55 million on Nasdaq at a company value of $232 million.

Tali Tsipori 20 Oct 05 15:15

Israeli biotechnology company Predix Pharmaceuticals Holdings, which was scheduled to complete the pricing stage for its Nasdaq IPO last night, has apparently been forced to postpone it by one day. Predix was expected to raise $55 million at a company value of $211-253 million (average company value - $232 million). Trading in the company share will therefore begin tomorrow under the PRDX ticker symbol.
Predix will issue five million shares in the $10-12 price range. The underwriters -- UBS Investment Bank, Deutsche Bank Securities, ThinkEquity Partners LLC, and CIBC World Markets Corp. -- will receive an option to buy 750,000 more shares from the company, which would increase the proceeds by $8.3 million.

Predix focuses on the discovery and development of new drugs for treating diseases linked to G-Protein coupled receptors.

Published by Globes [online] - www.globes.co.il - on October 20, 2005

Dubi

Rfj,

Good questions, none of which i can answer, therefore
forwarded to IR.A good opportunity to find how investor
friendly, and helpful they are.

Regards,

Dubi

PRDX

Looking for a place to invest my ill-gotten BCRX gain...

Any sense on when this phase III will complete and how many phase III trials will be required (they say at least two, I suspect more)? Any sense on what kind of data package will be required for submission?

I reviewed the labels for several approved agents for GAD. The venlafaxine (Effexor) label has a total of four studies in GAD, including two 6-week studies and two 24-week studies. I have no idea which data they used for approval.

Although cross-agent comparisons are difficult, it doesn't look like this is any more efficacious than other agents out there for GAD. It might be better tolerated, but speaking from experience APRs are a big deal for the FDA.

Also, what makes them think that this agent is deserving of a SPA?

Thanks,

John

Phase III Study Design
The Phase III trial is an eight-week, double-blind, placebo-controlled, multi-center study. The trial includes approximately 20 sites in the United States and is expected to enroll up to 310 patients with moderate-to-severe GAD who will be randomized into one of two arms, consisting of approximately 155 patients each: a placebo arm, or a PRX-00023 treatment arm, in which patients receive a dose of 40 mg administered over a three-day period followed by an 80 mg once daily for the remainder of the study. The primary objectives in this trial are to evaluate the efficacy of PRX-00023 in GAD as measured by the change from baseline in the HAM-A scale, and to assess the safety and tolerability of PRX-00023 during treatment of patients with GAD. The HAM-A scale is the only FDA accepted standard for the evaluation of anti-anxiety activity, and it is used in all pivotal trials of drug candidates for the treatment of GAD. This trial will be the first of at least two pivotal trials with PRX-00023 for the treatment of GAD.

Biotech co Predix goes public on Wed

Predix Pharmaceuticals Holdings will raise $55 million at $232 million value.

Tali Tsipori 16 Oct 05 20:19

If all goes as planned, Israeli biotechnology company Predix Pharmaceuticals Holdings will hold its initial public offering (IPO) on Nasdaq this week. Predix is expected to complete the pricing stage of the IPO this coming Wednesday, and trading in the share will begin the following day, under the ticker symbol PRDX. Predix intends to raise $55 million at $232 million company value.
Predix will float 5 million shares with a price range of $10-12. The IPO underwriters -- sole book-running manager UBS Investment Bank, co-lead manager Deutsche Bank Securities Inc., and co-managers CIBC World Markets Corp. and ThinkEquity Partners LLC -- will receive the option to acquire an additional 750 shares, thus increasing the total IPO amount by $8.3 million.

Predix is a pharmaceutical company focused on the discovery and development of novel, highly selective, small-molecule drugs that target G-protein coupled receptors (GPCRs) and ion channels.

Predix has three drug candidates in clinical trials: one for the treatment of generalized anxiety disorder, one for the treatment of Alzheimer’s disease, and one for the treatment of pulmonary arterial hypertension. Predix has six additional programs in preclinical development and discovery.

Published by Globes [online], Israel business news - www.globes.co.il - on Sunday, October 16, 2005

http://www.globes.co.il/serveen/globes/docview.asp?did=1000020702&fid=942

IMHO, a company worth following.

Dubi

Predix Pharmaceuticals to raise $55m at $232m value

Three Israeli companies have raised a total of $314 million in IPOs on in New York in 2005.

Tali Tsipori 6 Oct 05 17:35

Biotechnology company Predix Pharmaceuticals took another step towards its IPO on Nasdaq at the end of last week. In its second draft prospectus submitted to the US Securities and Exchange Commission (SEC), Predix said that it planned to become a public company at a company value of $211-253 million (average company value - $232 million). Predix will issue five million shares at $10-12 per share, raising $50-60 million (average - $55 million). The issue does not include an offer to sell by the company’s shareholders. The underwriters - UBS Investment Bank, Deutsche Bank Securities, ThinkEquity Partners LLC, and CIBC World Markets Corp. will receive an option to buy 750,000 more shares from the company, which would increase the proceeds by $8.3 million.
When the issue is completed, Predix will be traded under the ticker symbol PRDX. Other Israeli biotechnology companies listed on Nasdaq include Keryx Biopharmaceuticals Inc. (Nasdaq: KERX;), Compugen (Nasdaq: CGEN; TASE: CGEN), and Pharmos Corporation's (Nasdaq: PARSD). If Predix’s IPO goes through, it will be the fourth IPO in New York by an Israeli company this year, following issues by Shamir Optical Industries Ltd. (Nasdaq: SHMR; TASE: SHMR), Alon USA Energy Inc. (NYSE: ALJ), and Ituran Location and Control Ltd. (Nasdaq: ITRN); TASE: ITRN), which raised an aggregate $314 million.

In its draft prospectus, Predix states that the proceeds from the issue will be used to finance clinical trials, pre-clinical trials, and other R&D activity.

Predix is the result of a merger in 2003 between Israeli start-up Predix and private US company Physiome Sciences. Three people founded Predix in 2000: Dr. Silvia Noiman, Dr. Oren Becker, and Pharmos chairman and CEO Dr. Haim Aviv. Aviv has been inactive in the company since 2002, and does not hold shares in it.

Predix focuses on the discovery and development of new drugs for treating diseases linked to G-Protein coupled receptors.

Predix’s three drugs are currently in various phases of clinical trials, and six more are in the discovery or pre-clinical development phases. The company’s most prominent drug is PRX-00023, designed for treatment of generalized anxiety disorder.

Published by Globes [online] - www.globes.co.il - on October 6, 2005

Dubi

Ramat Gan-based Predix, which develops new medicines through integrated computational and medicinal chemistry platforms, filed for an IPO in August, and, again, although it has not yet specified its share price range, it plans on raising $70 million.

http://tinyurl.com/brjj2

Dubi

Israeli biotech leader asked by Cystic Fibrosis Foundation to develop treatment
By Sharon Kanon August 28, 2005

A company must be doing something right if the American Cystic Fibrosis Foundation provides it with $12.5 million in funding to research and develop an effective treatment for this debilitating genetic disease.

That company, Predix Pharmaceuticals Holdings Inc., founded in Israel in 2000, has won the confidence of the Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), the drug development affiliate of the Foundation.

"We have been extremely impressed with Predix's drug discovery and development track record," says Robert J. Beall, Ph.D., president and CEO of the CF Foundation and CFFT. "This agreement will enable us to work with a cutting-edge company to focus on promising research...We are confident that collaborating on these research programs will move us closer to finding an effective therapy to restore function to CF cells in patients with cystic fibrosis."

Cystic fibrosis (CF) affects approximately 30,000 children and adults in the US alone. A defective gene causes the body to produce an abnormally thick, sticky mucus that clogs the lungs, leading to life-threatening lung infections, and obstructs the pancreas, causing difficulty absorbing food. The median life expectancy has improved from early childhood to the mid-30s today, but many individuals battle lung disease for years.

Why the vote of confidence in Predix? For one thing, the young company has a proprietary technology that has enabled it to develop a series of potential high-demand drugs - two of which are already in human clinical trials - all in the last two years. In fact, the Ramat Gan-based start-up is soon to become the first Israeli biotechnology company to float on the NASDAQ exchange.

The key to the company's success is its proprietary 3-D modeling program (PREDICT) which predicts and simulates the 3-D structure of G-protein coupled receptors (GPCR's), a family of proteins that are involved in many major diseases and form the basis of leading drugs today.

Two of the company's GPCR-type drugs, now undergoing clinical trials, are aimed at treating depression and Alzheimer's disease. A third drug for pulmonary hypertension is expected to enter clinical trials later this year.

"We have the first computer shortcut to GPCR drug discovery," says Dr. Oren Becker, co-founder with Dr.Sylvia Noiman of Predix Pharmaceuticals. Professor Chaim Aviv, a pioneer of biotechnology in Israel, was also involved in the initial founding of the company, originally called. Bio-IT.

The shortcut has enabled the company to identify several compounds that are potential high-demand drugs.

Like bees to honey, the success has attracted investors who raised a total of $43 million in an oversubscribed private offering in January. Predix had already raised $27 million in an earlier round of financing, plus $10 million in the seed stage. The company's computational division is in Israel; its headquarters in Woburn, Massachusetts, were set up in 2002. Predix has begun negotiating with various investment houses to conduct its initial public offering in the coming months according to a company value of between $160 million to $250 million.

"We are very excited with the results of our Phase I trials for the anti-anxiety, anti-depressant drug candidate. It will be developed as a drug with rapid onset of action and no sexual side effects," says Woburn-based President and CEO of Predix, Michael Kaufman (MD, PhD.-Johns Hopkins; post-doc, Harvard).

Speed and efficiency are buzz words in the company. "Our goal is to drive one or two novel drug candidates into clinical testing each year. We did that in 2004 with both our anxiety and depression programs, and our compound for Alzheimer's and other cognitive disorders," says Becker, Chief Scientific Officer.

"Moving a drug from in-silico discovery, through optimization and into clinical trials in less than two years demonstrates the power of our platform," says Becker. The company is already collaborating with one of the five largest pharmaceutical companies on one specific GPCR."

Predix has good reason to focus on G-Protein Coupled Receptors, a superfamily of proteins, which are primary drug targets today. Embedded in membranes, they facilitate "chat-cell talk," communication between the cell and its environment. Passing signals across the cell membrane, they signal a second messenger system to respond. The receptors are involved in a wide variety of body systems and processes and control the physiology of all the major organs in the body. Scientists have identified 800 different human G-PCRs-400 for taste, and 400 for other life functions. They are involved in major diseases?hypertension, cardiac dysfunction, depression, anxiety, asthma, obesity, inflammation, and pain. G-PCR's account for nearly 50% of all drugs on the market, and 30% of the top 50 best-selling drugs.

"It is all about getting the right key in the right lock," explains Dr. Sylvia Noiman, co-founder and general manager of Predix Pharmaceuticals, Israel. Noiman earned her Ph.D. in Molecular Biology at Tel Aviv University, and post-Doctorate at the Weizmann Institute of Science, after earning an MBA in parallel with a Masters in Science at TAU. An entrepreneur, as well as a scientist, Noiman had been been looking for cutting edge technology for drug development when she met Becker.

Co-founder Becker earned his Ph.D. in Theoretical Chemical Physics, wrote a highly praised textbook in the field and has been a Visiting Professor at Harvard.

The first lock Predix is fixing is a faulty GPCR protein that causes anxiety, depression, ADHD, and other similar maladies because it has a malfunctioning key. Initially, it is concentrating on a serotonim-based compound for anxiety.

"Hormones and other molecules (neurotransmitters and peptides) that are expressed in the brain and transmitted to the blood interact with GPCR which is the gateway in the membrane, on the periphery of the cell. If the fit of the key is correct, the hormone binds with the GPCR which then sends out signals that cascade in the cell. If the key is not working properly, there may be too much signaling or other problem which brings on illness," explains Dr. Noiman.

The key is in a database of two million compounds. "We are looking for the best key to interact with the lock," says Noiman. Filtering to a library of 150,000 compounds, Predix computational scientists screen out the best 100 compounds to test with the 3-D modeling technology.

"Our approach allows us to compete with companies with far greater resources because we focus on making fewer compounds, but with the right properties," said Becker. "We are the first to do rational screening rather than random screening which is used throughout the industry."

"We try to do screening in less than one year, screening that would take five years in a lab," says Dr.Yael Marantz, Senior Director, Computational Drug Discovery. Marantz was tapped for a key position at the start-up as soon as she finished her doctorate in computational chemistry at TAU.

She is eager to show a dynamic 3-dimensional image of the GPCR structure, a meshy protein characterized by seven tubular helixes. "We look for a hole, a pocket, a place to dock."

Maranz says that they are not just looking for a "hit." "Our goal is to find the best drug candidate - one that is more active, that does not decompose, has more metabolic stability, does not interact with other receptors, and has no side effects."

Predix's compound for anxiety scored high on the simulation test-stable with no side effects. Phase II trials are underway.

Another medical need, Predix is targeting is cardiac arrhythmia, caused when insufficient oxygen gets to the heart. Expensive defibrillators and ineffective drugs with side effects are not good medical solutions. The Israeli scientists have discovered an ion channel directed compound, which it is optimizing, and expects to reach pre-clinical testing within a year.

With seven drugs in the pipeline (including drug candidates for cancer and inflammation) Predix is setting a new pace in drug discovery. Its edge: "We put the computer up front," says Noiman.

Now the company will be setting its sights on developing a treatment for cystic fibrosis as well, by using its proprietary PREDICT technology to model the structure of a defective ion channel that ultimately leads to the symptoms of CF. Once the exact site of the channel is identified, Predix plans to use its computational drug discovery capabilities to discover a drug that restores proper functioning to the channel in patients with CF.

"Our technology has enabled us to advance two compounds from discovery into the clinic in less than two years," notes Chen Schor, chief business officer of Predix Pharmaceuticals. "We are excited about applying our drug discovery and optimization technology... for the benefit of patients with cystic fibrosis."

"This agreement is a perfect fit for Predix strategically and enables us to use our proven technology and discovery capabilities to help people battling this critical life-threatening disease," adds co-founder Becker.

http://tinyurl.com/bymox

Dubi

Predix Pharmaceuticals Initiates Phase III Clinical Trial of PRX-00023 in Generalized Anxiety Disorder; Provides Positive, Preliminary Findings from Phase II Study
8/15/2005 9:00:19 AM

LEXINGTON, Mass. & RAMAT GAN, Israel, Aug 15, 2005 (BUSINESS WIRE) -- Predix Pharmaceuticals, a drug discovery and development company, today announced the initiation of its first pivotal Phase III trial of PRX-00023, the company's novel 5-HT1A agonist, in patients with generalized anxiety disorder (GAD). The primary objective of the study is to evaluate the efficacy of PRX-00023 in GAD as measured by the change from baseline in the Hamilton Rating Scale for Anxiety (HAM-A).


"The initiation of this pivotal Phase III trial of PRX-00023 is an important milestone for Predix," said Michael G. Kauffman, M.D., Ph.D., president and CEO of Predix Pharmaceuticals. "This is the first of three internally discovered and developed drug candidates, currently in clinical trials, to enter Phase III."

Predix is currently in discussions with the Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for this trial. The FDA has accepted the proposed study design and primary endpoint while making recommendations regarding secondary endpoint selection which we have adopted. At the FDA's request, Predix is developing a detailed statistical analysis plan for this study to complete the SPA.

This Phase III study follows the recent completion of a Phase II study of PRX-00023 in patients with GAD. The Phase II study was an open-label, multi-center outpatient trial in 20 patients with the diagnosis of moderate-to-severe GAD at study entry (HAM-A score of 20 or higher). The primary objective was to assess the safety and tolerability of PRX-00023 during short-term treatment of patients with GAD. Following a one-week, single-blinded placebo run-in period, PRX-00023 was administered to patients in doses of 40 mg once daily orally for four days, followed by 80 mg once daily orally for 10 days and then 120 mg once daily orally for 14 days. The most frequently reported adverse event was flu-like symptoms, occurring in three patients.

There were no serious adverse events or drug-related adverse events leading to discontinuation in the Phase II study. The only patient discontinuation was due to an adverse event that was not deemed drug-related. Although this trial was not designed to demonstrate statistical significance, preliminary results from the secondary efficacy objectives, available for 19 of the 20 patients, were encouraging. PRX-00023, given for four weeks, significantly lowered measures of anxiety from baseline in this trial, including the HAM-A total score, HAM-A psychic subscale score, CGI-Global Improvement score, and Hospital Anxiety and Depression scale. For example, analysis of HAM-A scores showed that 13 of 19 patients (68%) were "responders" with a reduction in their HAM-A score from baseline of at least 40%. Further, six of 19 patients (32%) experienced a "remission" of anxiety (i.e., a return to normal function), with a reduction in HAM-A score to seven or less during treatment with PRX-00023. These results are preliminary and are based on a small number of patients and are not necessarily predictive of results in later-stage clinical trials with larger and more diverse patient populations.

Stephen Donahue, M.D., vice president of clinical and regulatory affairs added, "Our goal in this program is to develop PRX-00023 as a once-daily drug to treat anxiety and depression with no sexual side effects and with a rapid onset of action. We are very pleased with the initial safety and efficacy data from our Phase I and II trials. Our Phase II study demonstrated that PRX-00023 was well-tolerated over four weeks, and none of the patients discontinued due to drug-related adverse events. Further, we observed significant improvement from baseline in key markers of anxiety over four weeks, and more than 30 percent of patients treated with PRX-00023 returned to normal function, free of anxiety symptoms."

Phase III Study Design

The Phase III trial is an eight-week, double-blind, placebo-controlled, multi-center study. The trial includes approximately 20 sites in the United States and is expected to enroll up to 310 patients with moderate-to-severe GAD who will be randomized into one of two arms, consisting of approximately 155 patients each: a placebo arm, or a PRX-00023 treatment arm, in which patients receive a dose of 40 mg administered over a three-day period followed by an 80 mg once daily for the remainder of the study. The primary objectives in this trial are to evaluate the efficacy of PRX-00023 in GAD as measured by the change from baseline in the HAM-A scale, and to assess the safety and tolerability of PRX-00023 during treatment of patients with GAD. The HAM-A scale is the only FDA accepted standard for the evaluation of anti-anxiety activity, and it is used in all pivotal trials of drug candidates for the treatment of GAD. This trial will be the first of at least two pivotal trials with PRX-00023 for the treatment of GAD.

About PRX-00023

PRX-00023 is Predix's lead drug candidate and represents a novel, highly selective , non-azapirone class of 5-HT1A agonists discovered using PREDICT(TM), the company's proprietary GPCR modeling, screening and lead optimization technology. Buspirone is currently the only 5-HT1A agonist approved in the United States for GAD, but must be taken three times a day, requires approximately three weeks of dose adjustment to reach therapeutic levels, and may cause lightheadedness and nausea. Several other 5-HT1A agonists have shown efficacy in Phase II and III clinical trials in depression. However, most of these drugs belong to a chemical class of drugs called azapirones and their development has been hindered by poor tolerability at therapeutic doses, rapid metabolism, resulting in a short half-life and, therefore, requiring multiple daily dosing, and the requirement of slow dose escalation to effective doses because of nausea and lightheadedness, which are thought to be caused by their binding to off-target G-Protein Coupled Receptors (GPCRs).

In contrast, PRX-00023 is designed to have minimal affinity for the GPCRs associated with the side effects of 5-HT1A agonists that are in the azapirone chemical class, and to have a more convenient dosing profile than azapirones.

About Predix

Predix Pharmaceuticals Holdings, Inc. is a pharmaceutical company focused on the discovery and development of novel, highly selective, small-molecule drugs that target GPCRs and ion channels. Using its proprietary drug discovery technology and approach, Predix has advanced three drug candidates into clinical trials and has six additional programs in preclinical development and discovery. Predix's lead clinical-stage drug candidate, PRX-00023, completed a Phase II clinical trial in patients with GAD in July 2005 and entered the first of at least two pivotal Phase III clinical trials for this indication in August 2005. Its two other clinical-stage drug candidates, PRX-03140 for the treatment of Alzheimer's disease and PRX-08066 for the treatment of Pulmonary Arterial Hypertension are in Phase I clinical trials. For more information on Predix, please visit www.predixpharm.com.

Dubi

Predix Pharmaceuticals Files for Initial Public Offering
Wednesday August 3, 6:11 pm ET


LEXINGTON, Mass. & RAMAT GAN, Israel--(BUSINESS WIRE)--Aug. 3, 2005--Predix Pharmaceuticals, a drug discovery and development company, today announced that it has filed a registration statement with the Securities and Exchange Commission (SEC) relating to the proposed initial public offering of primary shares of its common stock.
UBS Investment Bank will be acting as the sole book-running manager. Deutsche Bank Securities Inc. will be a co-lead manager and CIBC World Markets Corp. and ThinkEquity Partners LLC will be co-managers.

This offering will be made only by means of a prospectus. When available, a written preliminary prospectus relating to this offering may be obtained from UBS Investment Bank, Prospectus Department, 299 Park Avenue, New York, NY 10171.

A registration statement relating to these securities has been filed with the SEC, but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any State in which such offer, solicitation or sale would be unlawful prior to their registration or qualification under the securities laws of any such State.

About Predix

Predix Pharmaceuticals Holdings, Inc. is a pharmaceutical company focused on the discovery and development of novel, highly selective, small-molecule drugs that target G-Protein Coupled Receptors (GPCRs) and ion channels. Using its proprietary drug discovery technology and approach, Predix has advanced three drug candidates into clinical trials and has six additional programs in preclinical development and discovery. Predix's lead clinical-stage drug candidate, PRX-00023, completed a Phase II clinical trial in patients with Generalized Anxiety Disorder in July 2005, and Predix expects to begin screening patients for the first of at least two pivotal Phase III clinical trials for this indication in early August 2005. Its two other clinical-stage drug candidates, PRX-03140 for the treatment of Alzheimer's disease and PRX-08066 for the treatment of Pulmonary Arterial Hypertension, are in Phase I clinical trials.

Contact:
Predix Pharmaceuticals
Kim Drapkin, CFO, 781-372-3272
or
Pure Communications
Andrea Johnston, 910-681-1088
Sheryl Seapy, 949-608-0841


Source: Predix Pharmaceuticals

http://biz.yahoo.com/bw/050803/35982.html?.v=1

Company: PREDIX PHARMACEUTICALS ISRAEL

DOCUMENT STRUCTURE:

General information
Available R&D capabilities

--------------------------------------------------------------------------------

CONTACT DATA Organization: PREDIX PHARMACEUTICALS ISRAEL
Contact: Name: Dr. Silvia Noiman
Position: General Manager Israel

Address: 3 Hayetzira St., S.A.P. Building
Ramat Gan
ISRAEL, 52521
Telephone: 03-6128590
Fax: 03-6128528
Email: noiman@predixpharm.com
WEB site: www.predixpharm.com




--------------------------------------------------------------------------------

GENERAL INFORMATION


Established: 2000
Ownership: Private

Core business

Bioinformatics;
Computational drug discovery.


Employees: 33
Market regions: USA, Europe
Main Markets: Biotechnology & Pharmaceutical Companies


Overview

PREDIX PHARMACEUTICALS (formerly Bio Information Technologies
Ltd. (Bio-IT)) is a computational drug discovery company, which
develops novel computational tools that accelerate and improve
drug discovery. The Company has developed cutting-edge, unique
and revolutionary algorithms to predict the 3-dimensional
structure of G protein coupled receptors (GPCRs), which are
considered to be the most important protein targets for drug
discovery.

PREDIX has developed a unique proprietary computational
technology (PREDICT) for predicting the three-dimensional
structure of any G-protein coupled receptors. The company's
technology overcomes the limitations of existing models. Predix's
approach is very general, and has the advantage that it requires
only the protein primary sequence (genomic information) as input,
making it a true bridge from the genome to drugs.

The PREDICT technology has so far been applied to a variety of
GPCRs. The results validate the technology both with respect to
the quality of the models and with respect to their value in the
context of drug discovery. The results also indicate that the
technology can handle the expected diversity of GPCR structures.

PREDIX PHARMACEUTICALS intends to use its proprietary
computational technologies to find small molecule lead drugs for
a broad range of human disease in which GPCRs are involved.



AVAILABLE R&D CAPABILITIES

Expertise
R&D technology: Bioinformatics
R&D applications: Drug leads, drug discovery
Available R&D facilities
R&D employees: 6
R&D professionals: 6



http://www.matimop.org.il/newrdinf/company/c3810.htm

Dubi

Background info & archived material.

http://www.investorshub.com/boards/read_msg.asp?message_id=5749204&txt2find=predix+

http://www.investorshub.com/boards/read_msg.asp?message_id=6028921&txt2find=predix+

http://www.investorshub.com/boards/read_msg.asp?message_id=6804002&txt2find=predix+

http://www.investorshub.com/boards/read_msg.asp?message_id=7224765&txt2find=predix+

http://www.investorshub.com/boards/read_msg.asp?message_id=7224917&txt2find=predix+

http://www.investorshub.com/boards/read_msg.asp?message_id=7225075&txt2find=predix+

Dubi